Chapter 1Introduction
1.1The Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2025 was introduced by the Assistant Minister for Health and Aged Care and Assistant Minister for Indigenous Health, the Hon. Ged Kearney MP (the Assistant Minister), to the House of Representatives on 28November2024.
1.2On 6 February 2025, the Senate referred the provisions of the bill to the Community Affairs Legislation Committee (the committee) for inquiry and report by 3 April 2025.
Structure of the report
1.3This report contains two chapters. This chapter sets out:
the purpose of the bill;
background information relating to the Independent Review of Medicare Integrity and Compliance and the broader context for these reforms;
an overview of the bill’s key provisions;and
general information outlining the conduct of the inquiry and other committees’ consideration of the bill.
1.4Chapter 2 examines the key views of submitters and concludes with the committee’s view and recommendation.
Purpose of the bill
1.5This bill would amend the Health Insurance Act 1973 (the Health Insurance Act), the National Health Act 1953 (the National Health Act), the Human Services (Medicare) Act 1973 (the Human Services Medicare Act), the Dental Benefits Act 2008 (the Dental Benefits Act), the Therapeutic Goods Act 1989 (the Therapeutic Goods Act), and the Public Health (Tobacco and Other Products) Act 2023 (theTobaccoAct).
1.6According to the Revised Explanatory Memorandum, these measures are intended to ‘protect the integrity of Medicare, enhance the regulation of goods under the Therapeutic Goods Act and make minor amendments to the TobaccoAct’.
1.7The Department of Health and Aged Care (the Department) provided a broad overview of the bill’s amendments in its submission. It noted that the amendments relating to Medicare integrity are principally intended to:
(a)change the usual timeframe for making claims for payment in respect of bulk-billed services from 2 years to 1 year;
(b)update and broaden investigative powers to ensure they can be used appropriately across health benefits schemes and in relation to a broader number of offences;
(c)improve pharmacy approval processes;
(d)improve powers to obtain information about potential non-compliance and readily ascertain amounts that should not have been paid;and
(e)remove restrictions on the admission of some information, obtained under the notice to produce powers of the Professional Services Review (PSR), as evidence in certain proceedings.
1.8Additionally, in its submission, the Department provided an overview of the amendments to the Therapeutic Goods Act:
(a)enhance the effectiveness of the Secretary’s power to address and alleviate the consequences of critical shortages of therapeutic goods inAustralia;
(b)enable regulations to be made to prescribe circumstances in which the Secretary must not authorise a medical practitioner, under the Authorised Prescriber Scheme, to supply therapeutic goods that are not included in the Australian Register of Therapeutic Goods;
(c)revise several provisions in Part 6-2 that deal with entry to and searches of premises, as well as warrants to undertake such action, to ensure they are better aligned with the model provisions in the Regulatory Powers (Standard Provisions) Act 2014;and
(d)improve the flexibility and effectiveness of the Secretary’s compliance and enforcement powers to remove unlawful and unsafe therapeutic goods and vaping goods from the market.
1.9Finally, the Department noted that the Tobacco Act would also enable the making of regulations to facilitate phase in and phase out of future series of regulated tobacco product requirements.
1.10The bill’s key provisions are discussed in further detail later in thischapter.
Background
1.11The Revised Explanatory Memorandum noted that a number of the amendments in the bill form part of the government’s response to the Independent Review of Medicare Integrity and Compliance, conducted by Dr Pradeep Philip (the Philip Review). Key findings of the Philip Review are discussedbelow.
1.12Additionally, the Department also consulted on the amendments to the Therapeutic Goods Act and the Tobacco Act, which is outlined below.
Independent Review of Medicare Integrity and Compliance
1.13In November 2022, the Minister for Health and Aged Care, the Hon. Mark Butler MP (the Minister), announced an independent review into Medicare compliance, led by health economist Dr Pradeep Philip (the Philip Review).
1.14The Philip Review was announced following a 2020 Australian National Audit Office report that estimated ‘the value of Medicare non-compliance at between $366 million and $2.2 billion a year’.
1.15As such, the Minister stated that the Philip Review would assess ‘the possible value of fraudulent, non-compliant or over servicing risks in Medicare and provide a methodology and evidence-based estimate of the likely value of non-compliance in Medicare’.
1.16In March 2023, Dr Philip presented his final report of the Independent Review of Medicare Integrity and Compliance. Dr Philip reported that:
Legislation, governance, systems, processes, and tools are currently not fit for purpose and, without significant attention, will result in significant levels of fraud.
1.17Dr Philip further noted that it is ‘entirely feasible the value of non-compliance could exist in the range of $1.5 billion to $3 billion’ but emphasisedthat:
… the main lesson to learn from this Review is that we must focus on the structural issues and controls in the system, to build trust in Medicare and materially reduce non-compliance and fraud.
1.18Dr Philip emphasised that ‘non-compliance and fraud is about trust in Medicare’, and that non-compliance and fraud also impact the quality of care that patients receive.
1.19In its submission, the Department explained that the Philip Review made a range of recommendations about how to strengthen the integrity of Medicare programs, and how to improve compliance processes.
1.20The Philip Review did so after consultation with 21 interested parties, including health professional representative groups, the medical indemnity sector, individual and independent consumers and Government agencies.
1.21Further, the Revised Explanatory Memorandum explained that the Philip Review referred to the need for integrity activities to identify and respond to actors within the system who are unintentionally or dishonestly obtaining an incorrect payment. The Revised Explanatory Memorandum also highlighted the need to ensure patient safety in all aspects of health services, as referred to in the Philip Review.
1.22In 2023, the Health Insurance Amendment (Professional Services Review Scheme) Act 2023 and the Health Insurance Amendment (Professional Services Review Scheme No. 2) Act 2023 made priority amendments in response to the PhilipReview.
1.23As noted above, a number of the bill’s provisions also form part of the government’s response to the Philip Review, including amendments related to the integrity of Australia’s health schemes, as well as amendments that ensure robust systems are in place to prevent, identify, and respond to instances of non-compliance and fraud. Provisions related to the reduction in claims timeframe, which is discussed later in this chapter, were also announced as a measure in the 2024–25Budget.
Consultation on amendments
1.24The Revised Explanatory Memorandum advised that the Department consulted with the Attorney-General’s Department, the Department of Social Services, Services Australia, the Commonwealth Director of Public Prosecutions, and the Professional Services Review Agency on the Medicare integritymeasures.
1.25Additionally, the Revised Explanatory Memorandum outlined that the Department consulted with stakeholders on the proposed amendment to clarify that section 61 of the Therapeutic Goods Act is not a ‘secrecy’provision.
1.26It noted that while most respondents did not have concerns about this amendment, Medicines Australia and Complementary Medicines Australia opposed it on the basis that they considered it to be unnecessary.
1.27The Revised Explanatory Memorandum also advised that the Attorney-General’s Department was generally supportive of other therapeutic goods and vaping goods measures, such as amendments relating to forfeiture arrangements, enforceable direction and delegations.
1.28The Attorney-General’s Department recommended that the Department undertake a privacy impact assessment to support the proposed amendments in relation to the Secretary’s delegation power under the Therapeutic Goods Act, noting that it would increase the entities who may collect, use, disclose and retain personal information, and may also include the handling of sensitive personalinformation.
1.29The Revised Explanatory Memorandum advised that jurisdictions were generally supportive of the proposed amendments, noting that the amendments would enhance the ability to monitor, investigate and enforce compliance with the Therapeutic Goods Act and regulations.
1.30Each jurisdiction was also consulted on whether or not it would be practical to limit these powers to the Senior Executive Service. Queensland stated this would not be practical, whereas other jurisdictions were either agreeable or did notrespond.
1.31The Revised Explanatory Memorandum noted that in the absence of any consensus, the Department intends to consider other mechanisms to protect privacy prior to delegating powers to state and territory officers. This includes making a direction under the Therapeutic Goods Act to require delegatesto:
Take reasonable steps to limit the collection of personal information (unless relevant to an investigation); and
Make best efforts to comply with the requirements of the Commonwealth PrivacyAct.
1.32The Revised Explanatory Memorandum also advised that the Department did not undertake any consultation in relation to other amendments to the Therapeutic Goods Act, as they are minor, machinery or consequential in nature, or would correct an error.
1.33Similarly, it noted that extensive consultation was conducted by the Department on the Tobacco Act, and that it was therefore not considered necessary to further consult on the amendments to the Tobacco Act in this bill as they are clarifications consistent with original policy intent.
Financial impact statement
1.34The bill’s financial impact statement advised that reducing the usual maximum timeframe for making bulk-billed claims is expected to produce savings of up to$33.6million.
1.35The financial impact statement also noted that the government will provide $82.0 million over four years from 2023–24 to support vaping reforms, awareness raising and enforcement activities,which includes:
$56.9 million over two years from 2023–24 to the Therapeutic Goods Administration to support regulatory development activities; and
$25.0 million over two years from 2023–24 to support the Australian Border Force’s regulatory and enforcement activities.
1.36Further, the financial impact statement explained that this measure builds on the Vaping Regulation Reform and Smoking Cessation Package under the 2023–24Budget. It elaborated that the ‘package committed to ban all vapes, other than therapeutic vapes imported, manufactured or supplied in accordance with the Therapeutic GoodsAct’.
1.37Additionally, the financial impact statement stated that the vaping reforms support the government’s implementation of the National Tobacco Strategy2023–2030.
1.38Finally, the financial impact statement noted that other measures within the bill ‘are expected to result in increased recovery of amounts to the Commonwealth but have not been specifically costed’.
1.39The Supplementary Explanatory Memorandum advised that the amendments to the bill (discussed later in this chapter) do not alter the financial impact ofthebill.
Key provisions of the bill
1.40This section outlines the bill’s key provisions. The bill contains four Schedules, each containing multiple parts:
Schedule 1 – Medicare integrity amendments.
Schedule 2 – Therapeutic goods amendments.
Schedule 3 – Public health tobacco amendments.
Schedule 4 – Additional amendments to improve medicare integrity.
Commencement
1.41Clause 2 provides that the bill, if passed, would commence as follows:
Sections 1 to 3 commence on the day of Royal Assent. The measures in Schedules 1 and 4 have various commencement arrangements, and the measures in Schedules 2 and 3 commence the day after RoyalAssent.
Schedule 1 – Medicare integrity amendments
1.42Schedule 1 contains three Parts. It would amend the Dental Benefits Act, Health Insurance Act, Human Services (Medicare) Act, and the National Health Act.
Part 1 – Amendments relating to timeframe for bulk-billed claims
1.43Part 1 consists of three Divisions. Division 1, comprised of items 1 and 2, relates to the Dental Benefits Act. Item 1 would change the timeframe for claims relating to assigned dental benefits from two years to one year, unless the Chief Executive Medicare has allowed a longer period.
1.44The Revised Explanatory Memorandum explained the process for assigned dental benefits by stating:
An assigned dental benefit involves a person transferring their right to the payment of a dental benefit to a provider who accepts the assignment as full payment for the expenses incurred in respect of a dental service. This practice is commonly known as “bulk billing”. When a service is bulk-billed, the dental provider is not allowed to charge the person an additional fee for the dentalservice.
1.45The Revised Explanatory Memorandum noted that the legislation currently enables a person to make an application for a longer period to make a claim and clarified that this provision would not change.
1.46It also commented that this change is ‘likely to have minimal impact on patients and dental providers’, as most claims are made within one year.
1.47Item 2 clarifies that the amendment 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.
1.48Provisions within Division 2 make amendments to the Health Insurance Act. For instance, Item 3 would change the timeframe for making claims relating to some assigned Medicare benefits from two years to one year, unless the Minister has allowed a longer period.
1.49The Revised Explanatory Memorandum emphasised that changing the timeframe from two years to one year would improve the integrity of payments, and, like Item 1, that the change is likely to have minimal impact on patients and practitioners, as most claims are already made within one year.
1.50The Revised Explanatory Memorandum underlined that the changes do not affect claims for benefits assigned or taken to have been assigned under subsection20A(2A).
1.51Item 4 refers to the Minister’s discretion to consider applications for assigned medicare benefits claims made outside the usual timeframe.
1.52Provisions within Division 3 also relate to the Health Insurance Act. For instance, according to the Revised Explanatory Memorandum, Item 7 changes the timeframe for claims relating to bulk billing assignments from two years to one year, unless the Minister has allowed a longer period under subsection3A.
Part 2 – Amendments relating to criminal offences
1.53Provisions under this Part relate to criminal offences in the Human Services (Medicare) Act. Item 9 replaces the definition of ‘relevant offence’ under section 3A. The Revised Explanatory Memorandum explained that this new definition would enable ‘a broader and more consistent use of the investigative powers contained in Part IID of the Human Services (Medicare) Act’.
1.54The Revised Explanatory Memorandum explained that Part IID includes notice to produce information or documents, searches of premises with the occupier’s consent, and search and seizure powers under a warrant.
1.55The Revised Explanatory Memorandum noted that existing definitions in the Human Services (Medicare) Act have resulted in ‘arbitrary gaps in the ability to exercise investigative powers’. It also highlighted existing limitations that ‘significantly impact the Department’s ability to appropriately respond to high value potential PBS fraud matters’.
1.56As such, it concluded that a single uniform definition of a relevant offence would enable ‘the investigative powers in Part IID to be used consistently in respect of health benefits schemes and in relation to a broader range of Criminal Codeoffences’.
1.57Specifically, it noted that the new, single definition would enable the investigation of an offence that relates to:
claims for payment in respect of a professional service, dental service or the supply or purported supply of a pharmaceutical benefit;
an indemnity scheme payment; or
a Commonwealth contribution (within the meaning of the Midwife Professional Indemnity (Commonwealth Contribution) Scheme Act 2010).
1.58Item 10 would amend section 8U to omit ‘within the previous 60 days’. The Revised Explanatory Memorandum explained that the current power to search a premises with consent is subject to a 60-day timeframe. It noted that this is a short timeframe, and that by removing this time limit it would make the provision consistent with other sections of the Human Services (Medicare) Act.
1.59It concluded that the timeframe expansion is reasonable and proportionate for the purpose of being able to enforce the relevant offences, noting the ‘practical reality of time delays in reporting and detecting fraud and commencinginvestigations’.
1.60Item 11 would amend section 8ZG to introduce ‘an option for data copied at warrant premises to be returned to the occupier of the premises at that time, instead of having to be destroyed’.
1.61Similarly, Item 12 would amend section 8ZGA to ‘introduce an option for data copied from electronic equipment found at warrant premises to be returned to the occupier of the premises at that time, instead of having to be destroyed’.
1.62Item 13 relates to application provisions. The Revised Explanatory Memorandum clarified that the amendments to the ‘relevant offence’ definition will apply to the investigation of conduct (including an omission) which relates to a relevant offence, where the conduct occurs before, on or after commencement. It noted that this will enable:
… investigative powers to be used to investigate conduct that relates to a relevant offence, regardless of whether that conduct was within the definition of “relevant offence” at the time it took place.
Part 3 – Amendments relating to approvals of pharmacists
1.63Division 1 of this Part (Items 14 to 23) pertains to requests for the Minister to approve pharmacists under the National Health Act, including some provisions that are consequential amendments.
1.64Currently, the National Health Act currently provides that the Secretary may, upon application by a pharmacist, approve that pharmacist to supply pharmaceutical benefits from particular premises.
1.65Where applications do not meet certain requirements related to location, section 90A of the National Health Act provides the Minister with a discretionary power to substitute the Secretary’s decision to reject an application because it did not meet these requirements with a decision to approve the pharmacist to supply pharmaceutical benefits at particular premises.
1.66Section 90B provides the process by which a pharmacist may request the Minister to exercise this discretionary power to substitute a decision. The amendments within this Part reduce the timeframe in which the Minister can use this power by replacing the existing two-stage process with a shorter, single stageprocess.
1.67Additionally, Item 20 would add new subsection 90C(3) to prevent a request to the Minister being made within 12 months of the Minister making a decision in relation to a request by the same applicant for the same premises. The Revised Explanatory Memorandum explained that this is because it is unlikely the circumstances would have changed within this period.
1.68The Revised Explanatory Memorandum elaborated that this would reduce administrative burden for the Minister, the department, pharmacies applying for approval, and nearby pharmacies who are invited to comment each time a pharmacist reapplies for approval.
1.69Division 2 (Items 24 to 26) relates to other amendments to the National Health Act. For instance, Item 24 provides for delegation of approval of the form on which a request to the Minister must be made by amending paragraph 6(1)(ab) of the National Health Act.
1.70The Revised Explanatory Memorandum explained that this would enable the delegation of the Minister’s power to determine and approve the form in which a request is made under subsection 90B(1). It elaborated that this would remove the need for the Minister to approve the form, which is an administrative matter, thereby allowing more timely changes to be made to the form as needed.
1.71Additionally, Item 25 would provide that the Australian Community Pharmacy Authority’s appointment membership term be increased from two years tothree.
Schedule 2 – Therapeutic Goods Amendments
1.72Schedule 2 would amend the Therapeutic Goods Act. It contains nine Parts, which are discussed in the following sections.
Part 1 – Vaping measures
1.73Part 1 of Schedule 2 would make amendments to Chapters 2A, 4A, 5 and 7 of the Therapeutic Goods Act, which would clarify regulatory arrangements following the commencement of the Therapeutic Goods andOther Legislation Amendment (Vaping Reforms) Act 2024 (the Vaping Reforms Act).
1.74The Revised Explanatory Memorandum provided an overview of the key amendments’ effect, which are as follows:
Chapter 2A – would enable the making of regulations to prohibit dealings in vaping goods that are the subject of an international agreement to which Australia is a party;
Chapter 4A – would clarify in the offence and civil penalty provisions for supplying, and possessing, vaping goods, that the authority under which the Secretary may make a determination that the supply of particular vaping goods cease resides in the regulations;
Chapter 5 – would clarify that Part 5-1A of the Therapeutic Goods Act exclusively regulates the advertising of, and dissemination of generic information concerning vaping goods, and ensure the effective operation of that part by amending the circumstances in which a direction in relation to generic information can be made;and
Chapter 7 – would amend section 52G to preclude the Secretary from making an instrument under section 41R, or from giving a consent under section 41RC, relating to vaping goods that are the subject of a prohibition because those goods are the subject of an international agreement to which Australia is a party, under Chapter2A.
Part 2 – Persons assisting
1.75Part 2 would amend Part 6-2 of the Therapeutic Goods Act, according to the revised Explanatory Memorandum, to align certain provisions within Part 6-2 more closely with the model provisions of the Regulatory Powers (Standard Provisions) Act2014.
1.76The Revised Explanatory Memorandum stated that broadly, it is intended that these amendments will:
make the rights and obligations of occupiers of premises clearer, by ensuring that the powers and functions of persons assisting an authorised person under Part 6-2 are appropriately defined and regulated under the Therapeutic Goods Act; and
allow authorised persons who are executing a section 50 warrant improved flexibility to temporarily cease the execution of the warrant and leave the premises without precluding them from returning to complete the execution of the warrant.
Part 3 – Forfeiture
1.77The Revised Explanatory Memorandum explained that Part 6-2A provides a framework for the forfeiture of things seized in the exercise of certain powers under the Therapeutic Goods Act.
1.78Currently, Section 52AAA of the Therapeutic Goods Act sets out that things may be forfeit when seized under a section 50 warrant. Further, section 52AAB provides for the return or retention of a thing that is declared by a court not to be forfeited to the Commonwealth.
1.79The Revised Explanatory Memorandum outlined that Part 3 principally amends section 52AAA to broaden the circumstances in which the forfeiture arrangements in Part 6-2A are enlivened. It noted that the effect of these amendments is to provide that ‘section 52AAA applies not only in relation to things that are seized under a section 50 warrant, but also in relation to things that are seized under other provisions in Part 6‑2 (Entry, searches andwarrants)’.
Part 4 – Enforceable directions
1.80Part 4 of Schedule 2 would amend section 42YT of the Therapeutic Goods Act, which would substitute a new threshold that must be satisfied before the Secretary can give a direction to a person under that provision.
1.81The Revised Explanatory Memorandum explained that the purpose of these amendments is to better ensure the availability of such directions to protect Australians from new and emerging public health threats.
Part 5 – Delegation
1.82According to the Revised Explanatory Memorandum, Part 5 would amend subsection 57(1A) of the Therapeutic Goods Act to enable the delegation of the Secretary’s powers and functions under sections 45AB, 45AF and 45AG of the Therapeutic Goods Act to certain state and territory officers.
1.83The Revised Explanatory Memorandum highlighted that currently, subsection 57(1A) does not allow for the delegation of many of the Secretary’s powers to state or territory officers to require the provision of information or the production of documents under the Therapeutic Goods Act.
1.84The Revised Explanatory Memorandum explained that such powers are ‘essential’ in order to provide investigators with necessary information, so they can investigate potential non-compliance and develop a case against a person where non-compliance is found.
1.85It concluded that the Secretary’s current inability to delegate powers and functions under sections 45AB, 45AF and 45AG limits the extent to which the states and territories can monitor, investigate and enforce compliance with the Therapeutic Goods Act and raised that this is inconsistent with the objects of the Therapeutic Goods Act.
Part 6 – Therapeutic goods shortages
1.86Part 6 would amend sections 19A, 32CO and 41HD of the Therapeutic Goods Act. These amendments would clarify the circumstances in which the Secretary may approve the importation or supply of a therapeutic good that is not registered, or a biological or medical device that is not included, in the Australian Register of Therapeutic Goods (the Register).
1.87The Revised Explanatory Memorandum explained that these changes would enhance the Secretary’s capacity to manage and alleviate the potentially grave consequences of a shortage of a medicine, biological or medical device inAustralia.
Part 7 – Biologicals and breaching conditions of exemptions, approvals orauthorities
1.88According to the Revised Explanatory Memorandum, Part 7 of the Schedule ‘revises certain offence and civil penalty provisions in Part 32A of the Therapeutic Goods Act’.
1.89It explained that these provisions ‘apply in relation to breaches of a condition of an exemption, approval or authority granted or applying under the Therapeutic Goods Act in relation to an unapproved biological’, which are biologicals not included in the Register.
1.90It noted that the current offences and civil penalty provisions are not consistent with the tiered approach of most of the other offence provisions in the Therapeutic Goods Act. As such, the Revised Explanatory Memorandum noted that the intent of these amendments is to replace the existing offences with a ‘consolidated set of tiered offences and corresponding civil penaltyprovisions’.
1.91The Revised Explanatory Memorandum also highlighted that this is in line with provisions under Part 10, Schedule 1 of the Vaping Reforms Act, which are related to medicines and medical devices.
Part 8 – Review of decisions
1.92Part 8 of the Schedule would amend sections 7 and 60 of the Therapeutic Goods Act to ‘better clarify that the Secretary’s power to declare that a good meets, or does not meet, the definition of a ‘therapeutic good’ under the Act is legislative in nature’, and consequently:
section 7 should not include the mechanism currently in subsection 7(2), under which a person may apply to the Secretary for an exercise of the power; and
section 60 should not include merits review rights in connection with a refusal to make, vary or repeal a legislative instrument under section 7.
1.93The Revised Explanatory Memorandum outlined that the repeal of subsection 7(2) and paragraph 60(1)(a) would:
‘remove the reference to applications to the Secretary by a person for the Secretary to exercise their powers under subsection 7(1)’;and
‘exclude merits review rights in relation to a decision of the Secretary to refuse to make, or refuse to vary or repeal, a declaration under section 7 upon an application made under subsection 7(2)’.
1.94The Revised Explanatory Memorandum explained that the exclusion of merits review rights reflects that the power in section 7 to declare that a good meets, or does not meet, the definition of a ‘therapeutic good’ under the Therapeutic Goods Act, is legislative in nature and of broad application across classes ofproducts.
1.95It noted that in instances where the Secretary is of the view that a good falls within the scope of the ‘therapeutic goods’ definition, or that it falls outside the scope, section 7 provides the means to ensure clarity on the legislative parameters for affected product classes.
1.96It further observed that this approach is consistent with the Administrative Review Council’s ‘What decisions should be subject to merit review’ publication. This publication noted that:
… legislation-like decisions of broad application that are not directed to the circumstances of particular persons but which would apply generally to the community, are considered to be unsuitable for meritsreview.
Part 9 – Other amendments
1.97Part 9 of the Schedule makes other amendments to the Therapeutic Goods Act. The Revised Explanatory Memorandum provided an overview of the purpose of these amendments:
protect the privacy and safety of authorised persons under the Therapeutic Goods Act, by removing the Secretary’s obligation to publish the names of such persons in the Gazette or on the Department’s website;
clarify that the Secretary is not required to consider an application for consent under section 14, 14A, 41MA or 41MAA, or subsection 32BF(6), unless the applicant has paid the prescribed application fee;
enable regulations to be made that prescribe circumstances in which the Secretary must not grant an authority to a medical practitioner under the Authorised Prescriber (AP) Scheme;
more closely align the Secretary’s power to cancel the registration or listing of medicines from the Register that are also covered by an exemption, with the Secretary’s equivalent powers with respect to biologicals and medical devices; and
ensure that regulations that are made under the Therapeutic Goods Act may prescribe matters by reference to not only ‘instruments’, but also ‘other writing’, as in force or existing from time to time.
Schedule 3 – Public health tobacco amendments
1.98Schedule 3 contains four Parts which amend the Tobacco Act. An overview of these four Parts is provided below.
Part 1 – Advertisements of e-cigarette products that are vaping goods
1.99According to the Revised Explanatory Memorandum, amendments under Part 1 of Schedule 3 clarify the interaction between the Therapeutic Goods Act and the Tobacco Act advertising provisions relating to e-cigarettes (also known as vaping goods).
1.100The Revised Explanatory Memorandum noted that both of these Acts prohibit the advertisement of vaping goods (with a small number of exceptions), and that unauthorised advertising may be subject to offences and civil penalties under either of these Acts.
1.101Further, it outlined that a small number of provisions are repealed to harmonise the advertising prohibitions across both of these Acts.
Part 2 – Sponsorship
1.102The Revised Explanatory Memorandum explained that the Tobacco Act sets out a general prohibition of advertising and sponsorship for regulated tobacco items and includes equivalent prohibitions for e-cigarette products. The definitions of tobacco sponsorship and e-cigarette sponsorship are provided by sections 39 and 66respectively.
1.103Under this Part, Item 6 and 7 would amend subsections 39(1) and 66(1) to omit the word ‘individual’ in these provisions and instead substitute ‘person’. The Revised Explanatory Memorandum noted that the use of the word ‘individual’ potentially confines the application of the provision to individual persons.
1.104As such, it outlined that the substitution of ‘person’ would provide for a wider application, for instance, to sponsorships relating to either or both individual persons and companies.
1.105Item 8 would provide for an application provision for these amendments, in which amendments made by this Part apply in relation to a contribution (financial or otherwise) made on or after the day on which this Itemcommences.
Part 3 – Phasing-in and phasing-out of tobacco product requirements
1.106The Revised Explanatory Memorandum stated that the requirements under this Part ‘support the introduction of new tobacco product requirements in the future’, which is consistent with the policy intent of maintaining the currency and impact of tobacco product requirements.
1.107The Revised Explanatory Memorandum also noted that this facilitates the shutting off of offence provisions in the Tobacco Act for certain periods, which is necessary for industry to be able to engage in preparation work without committing an offence.
1.108It concluded that these provisions are important to facilitate the practical introduction of new tobacco product requirements, which in turn supports ongoing compliance with such requirements.
Part 4 – Appointment of authorised officers
1.109Section 150 of the Tobacco Act provides for the appointment of authorised officers for the purpose of Tobacco Act compliance and enforcement. Item 15 would omit ‘in the Department’ from paragraph 150(1)(a) of the Tobacco Act, which would allow Australian Public Service employees from other departments to be appointed as ‘authorised officers’.
Schedule 4 – Additional amendments to improve medicare integrity
1.110On 5 February 2025, the Assistant Minister presented a Supplementary Explanatory Memorandum. Additionally, on the motion of the Assistant Minister, Government amendments (1) and (2) were made together. The bill, as amended, was agreed to by the House of Representatives.
1.111The amendments added Schedule 4 to the bill. The Schedule consists of four Parts that are outlined below.
Part 1 – Amendments relating to administrative inquiries and recovery ofoverpayments
1.112Part 1 contains two Divisions that amend the Health Insurance Act:
Division 1 – Administrative inquiries:
Provisions in this Division relate to information that is relevant to Act administration. For instance, new section 129AACA would allow the Chief Executive Medicare to issue a notice requiring a person to give information, a document or a thing (required material) relevant to the administration of theHealth Insurance Act.
The Revised Explanatory Memorandum noted that the Chief Executive Medicare can issue a notice if they have reasonable grounds to suspect the person has the required material.
Section 129AACB provides the consequences of failure to give information relevant to Act administration. For instance, subsections 129AACB(1)-(2) would provide that a person commits a strict liability offence, with a maximum penalty of 30 penalty points, if they fail to comply with a notice under section 219AACA within the requiredperiod.
Division 2 – Recovery of overpayments:
This Division makes amendments in relation to overpayments. For instance, Item 5 inserts new section 129AAK (Recovery of amounts – overpayments in general). According to the Revised Explanatory Memorandum, this section is intended to complement existing powers to recover amounts under sections 129AC and 129AAD, and to provide a separate basis to recover unauthorised payments.
Part 2 – Contingent amendments relating to recovery of overpayments
1.113Part 2 contains three Divisions relating to the commencement of amendments:
Amendments if Modernising My Health Record amendments commence before or at the same time as Part 1;
Amendments if Modernising My Health Record amendments do not commence before or at the same time as Part 1;and
Amendments if Modernising My Health Record amendments commence after Part1.
Part 3 – Use and derivative use immunity
1.114Provisions in this Part relate to use and derivative use immunity. For instance, subsection 106ZPQ(1) of the Health Insurance Act currently specifies that a person who is required under subsection 89B(2) or 105A(2) to produce documents for inspections is not entitled to refuse on the ground that such a production might tend to incriminate him or her.
1.115Item 17 under Part 3 would insert a note under this provision to explain the operation of subsection 89B(2) or 105A(2). The Revised Explanatory Memorandum outlined that:
Under these subsections, a person may be required to produce documents relevant to a review of the person’s provision of services by the Director of the Professional Services Review (Director), and documents relevant to the referral made by the Director to a Professional Services Review Committee(Committee).
1.116Additionally, item 19 would amend subsection 106ZPQ(2) to identify ‘further kinds of criminal or civil proceedings in which documents, information or things produced under subsection 89B(2) or 105A(2) could be admitted in evidence’. This would include:
proceedings for an offence against subsection 106ZPN(1) (failing to produce documents), or section 106ZPP (false or misleading documents)
proceedings before a Committee or a Determining Authority;
proceedings to recover an amount recoverable, or required to be paid to the Commonwealth under Part VAA of the Health Insurance Act (which relates to the Professional Services Review Scheme); [and]
any other proceedings in relation to compliance with a requirement under Part VAA of the Health Insurance Act.
1.117Item 20 would insert new subsections 106ZPQ(3) and 106ZPQ(4), which relate to use and derivative use of materials compulsorily acquired under subsection 89B(2) or 105A(2).
1.118The Revised Explanatory Memorandum explained that these new subsections would set out limited exceptions to use and derivative use immunities where the material has been referred to persons or bodies under sections 106XA and 106XB of the Health Insurance Act.
Part 4 – Transitional rules for amendments made by this Schedule
1.119Item 22 under Part 4 relates to transitional rules. It enables the Minister, by legislative instrument, to make rules prescribing matters of a transitional nature to the enactment of the Schedule.
Compatibility with human rights
1.120The bill’s Statement of Compatibility with Human Rights (the statement) noted that the bill is ‘compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011’.
1.121As discussed above, this bill would amend various Acts. The human rights that the bill engages are outlined below.
Health Insurance Act, National Health Act, Dental Benefits Act, andHuman Services (Medicare) Act
1.122The statement noted that the bill engages the following human rights in relation to the proposed amendments to the Health Insurance Act, National Health Act, Dental Benefits Act, and Human Services (Medicare) Act:
the right to health under Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR);
the right to social security under article 9 of the ICESCR;
the right to privacy under Article 17 of the International Covenant on Civil and Political Rights (ICCPR);
the right to a fair trial and fair hearing rights under Article 14(1) of theICCPR;
the right to a presumption of innocence under Article 14(2) of the ICCPR;and
the right to be free from self-incrimination under Article 14(3)(g) of theICCPR.
Therapeutic Goods Act
1.123The statement highlighted that the bill engages the following human rights in relation to the proposed amendments to the Therapeutic Goods Act:
the right to health under Article 12 of the ICESCR;
the right to privacy under Article 17 of the International Covenant on Civil and Political Rights (ICCPR);
the right to freedom of expression under Article 19(2) of the ICCPR;
the right to a fair hearing under Article 14(1) of the ICCPR;and
the right to the presumption of innocence under Article 14(2) of the ICCPR.
Tobacco Act
1.124The statement outlined that the bill engages the following human rights under the Tobacco Act:
right to health under Article 12 of the ICESCR;
right to life under Article 6 of the ICCPR;
right to freedom of expression under Article 19(2) of the ICCPR;
right to a fair trial and fair hearing rights under Article 14(1) of the ICCPR;and
right to a presumption of innocence under Article 14(2) of the ICCPR.
1.125The statement concludes that the bill is compatible with human rights, as it ‘promotes and supports the right to health and other rights and, to the extent that it limits other rights, the limitations are reasonable, necessary andproportionate’.
Consideration by other committees
1.126Commentary on the bill by the Senate Standing Committee for the Scrutiny of Bills and the Parliamentary Joint Committee on Human Rights is consideredbelow.
Senate Standing Committee for the Scrutiny of Bills
1.127The Senate Standing Committee for the Scrutiny of Bills (Scrutiny of Bills committee) commented on the bill’s provisions in its Scrutiny Digest 1 of 2025, tabled on 5February2025.
1.128The Scrutiny of Bills committee also commented on the amendments in its Scrutiny Digest 2 of 2025. Key matters from both digests are summarised in the following sections.
Delegation of administrative powers
1.129The Scrutiny of Bills committee observed that currently, the Therapeutic Goods Act provides that the Secretary can delegate specified powers and functions under the Therapeutic Goods Act to state and territory officers.
1.130It noted that the bill seeks to amend this provision to expand the powers that may be delegated, including powers that relate to requiring information or documents, inspecting and copying documents, and retaining documents.
1.131The Scrutiny of Bills committee raised that it has ‘consistently drawn attention to legislation that allows the delegation of administrative powers to a relatively large class of persons, with little or no specificity as to their qualifications orattributes’.
1.132The Scrutiny of Bills committee commented that it generally prefers to see a limit set on the scope of powers that may be delegated or on the categories of people that the power can be delegated to. Specifically, the Scrutiny of Bills committee prefers that delegates are confined to the holders of nominated offices or to members of the Senior Executive Service.
1.133Further, where broad delegations are provided for, the Scrutiny of Bills committee stated that an explanation as to why these are considered necessary should be included in the explanatory memorandum.
1.134The Scrutiny of Bills committee noted information contained within the explanatory memorandum that advised that the intent is to ‘only delegate these powers to senior investigating officers and ensure there is national consistency in the use of these powers’. However, the Scrutiny of Bills maintained its concern that the provision does not specify this limit and allows for the Secretary to delegate specific powers to an officer, which would be expanded by the bill’samendments.
1.135Additionally, the Scrutiny of Bills committee noted that that while the stated intent to delegate to officers with appropriate seniority, it emphasised that this intent should be reflected in the bill’s provisions itself.
1.136As such, the committee sought the following advice from the Minister:
… the committee seeks the minister’s advice as to whether proposed subsection 57(1A) of the bill can be amended to either:
limit the persons to whom these powers can be delegated, such as to senior investigating officers or to specified persons of sufficient seniority in state and territory departments and offices; or
provide that the Secretary may only delegate the specified powers to the heads of relevant departments or agencies and those heads may only subdelegate when satisfied the subdelegate possesses the appropriate skills, qualification or experience to exercise the powers or perform thefunctions.
1.137In response, the Minister advised that they did not consider it was ‘practical, appropriate or desirable for these powers to be limited in either way’.
1.138The Minister provided several reasons for why it was appropriate to have flexibility in delegating powers to state and territory officials. This included enhancing the ability of state and territory officers to monitor, investigate and enforce compliance with the Therapeutic Goods Act, and accommodating for differing titles and position levels and organisational structure of state and territory agencies that may change from time to time.
1.139In relation to limiting the subdelegation arrangements only to those possessing appropriate skills, qualifications and experience, the Minister advised of a number of technical difficulties and that the Therapeutic Goods Administration (TGA) is well-equipped to advise the Secretary on the classes of persons whom delegations in state and territory authorities would be appropriate.
Strict liability offences
1.140The Scrutiny of Bills committee commented that it expects the explanatory memorandum to provide ‘a clear justification for any imposition of strict liability, including outlining whether the approach is consistent with the Guide to Framing Commonwealth Offences’, as strict liability ‘undermines fundamental common law principles’.
1.141Particularly, the Scrutiny of Bills committee noted that the Guide to Framing Commonwealth Offences states that strict liability is only considered appropriate where the offence is not punishable by imprisonment, and is only punishable by a fine of up to 60 penalty units for an individual.
1.142The Scrutiny of Bills committee observed that the penalty for the bill’s strict liability offence is 100 penalty units, which is higher than the threshold of 60 penalty units in the Guide to Framing Commonwealth Offences.
1.143In conclusion, the Scrutiny of Bills committee drew its scrutiny concerns to the attention of senators and left to the Senate as a whole the appropriateness of the strict liability offence under subsection 32CP(3), which carries a maximum penalty of 100 penalty units.
1.144The Minister provided additional information regarding these penalties and noted that the policy objective is to protect Australian patients from harm. In particular, the Minister noted that the inclusion of strict liability would enable the TGA to tailor enforcement action. The Minister further noted that he proposed higher maximum penalty of 100 penalty units (above the usual 60 penalty units) was justified because of the heightened potential risk to public health was consistent with other strict liability penalties in the Therapeutic Goods Act.
Abrogation of privilege against self-incrimination
1.145In its Scrutiny Digest 2 of 2025, the Scrutiny of Bills committee also commented on the two Government amendments agreed to by the House of Representatives on 5 February 2025.
1.146Commentary focussed on the abrogation of privilege against self-incrimination. The Scrutiny of Bills committee noted that section 106ZPQ of the Health Insurance Act abrogates the privilege against self-incrimination by providing that persons are not entitled to refuse to produce documents on the grounds that production of documents might tend to incriminate them.
1.147It further observed that use and derivate use immunity is applicable in relation to documents and information obtained, except for proceedings for an offence of providing false or misleading documents.
1.148The Scrutiny of Bills committee noted that Item 19 would limit when the existing use and derivative use immunities are applicable, meaning that any information, document or other material obtained under this provision is applicable in the following proceedings:
for offences for failing to produce documents or give information or for producing false or misleading documents;
before a Committee or the Determining Authority;
to recover an amount that is recoverable as a debt to the Commonwealth or otherwise required to be repaid to the Commonwealth; and
any other proceedings in relation to compliance with a requirement under Part VAA of the Health Insurance Act.
1.149Additionally, the Scrutiny of Bills committee observed that Item 20 would provide circumstances when information and certain derivative materials are admissible as evidence in these proceedings.
1.150Circumstances include where information, documents or other material is obtained by an appropriate person or body (who are prescribed by the regulations) under sections 106XA or 106XB of the Health Insurance Act for proceedings that are for the purposes of the National Law.
1.151The Scrutiny of Bills committee particularly noted that the exceptions to when use and derivative use immunity is not applicable would include proceedings to recovery a debt to the Commonwealth and any other proceedings in relation to compliance with a requirement under Part VAA of the Health InsuranceAct.
1.152As such, it observed that use and derivative use immunity could potentially not be applicable in a wide range of proceedings under this scheme, including criminal proceedings.
1.153The Scrutiny of Bills committee raised concerns and reiterated that the privilege against self-incrimination is a fundamental right under the common law and that any abrogation of that right represents a significant loss to personal liberty and the presumption of innocence.
1.154As such, the Scrutiny of Bills committee requests the Minister’s advice as to:
why it is necessary and appropriate that the exceptions to when use and derivative use immunity apply be expanded to include any proceedings in relation to compliance with a requirement under Part VAA of the Health Insurance Act 1973 (noting this can include criminal proceedings);
why it is necessary and appropriate derivative use immunity not apply to documents that are obtained by regulatory bodies or other appropriate persons under sections 106XA and 106XB of the Health Insurance Act 1973, allowing these documents or information to be admissible as evidence in certain proceedings; and
whether the Criminal Justice Division of the Attorney-General’s Department has been consulted in relation to this matter.
1.155It also noted that the consideration of this information would be assisted if the Minister’s response made reference to the principles in the Attorney-General’s Department’s Guide to Framing Commonwealth Offences, Infringement Notices and Enforcement Powers.
Parliamentary Joint Committee on Human Rights
1.156The Parliamentary Joint Committee on Human Rights made no comment on the bill in its Report 1 of 2025.
Conduct of the inquiry
1.157Details of the inquiry were made available on the committee’s website. The committee also contacted a number of organisations to invite them to lodge written submissions by 7 March 2025.
1.158The committee received nine submissions, which are listed at Appendix 1 of thisreport.
Acknowledgements
1.159The committee thanks the organisations and individuals who contributed to the inquiry by making written submissions.