Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2024 - Commentary on Ministerial Responses [2025] AUSStaCSBSD 37 (27 March 2025)

• Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 202490
• Broad delegation of administrative powers91
• Minister for Health and Aged Care response95
• Committee comment
• Strict liability offences96
• Additional correspondence from the Minister for Health and Aged Care102
• Committee comment

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Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2024^[90]

Purpose	The Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2024 (the Bill) seeks to amend the Health Insurance Act 1973, the National Health Act 1953, the Human Services (Medicare) Act 1973, the Dental Benefits Act 2008, the Therapeutic Goods Act 1989, and the Public Health (Tobacco and Other Products) Act 2023 to implement a number of public health measures.
Portfolio	Health and Aged Care
Introduced	House of Representatives on 28 November 2024
Bill status	Before the Senate

Broad delegation of administrative powers^[91]

2.34 The Therapeutic Goods Act 1989 (TG Act) currently provides that the Secretary can delegate specified powers and functions under the TG Act to state and territory officers.^[92] This bill seeks to amend this provision of the TG Act to expand the powers that may be delegated. These include powers in relation to requiring information or documents, inspecting and copying documents and retaining documents.^[93]

2.35 In Scrutiny Digest 1 of 2025 the committee requested the minister’s advice as to whether proposed subsection 57(1A) of the bill could be amended to:

• limit persons to whom the powers can be delegated, such as senior investigating officers or specified persons of sufficient seniority in state and territory departments and offices; or

• provide that the Secretary may only delegate the specified powers to heads of relevant departments or agencies, and those heads may only subdelegate when satisfied the subdelegate possesses appropriate skills, qualifications or experience to exercise these statutory powers or functions.^[94]

Minister for Health and Aged Care response^[95]

2.36 In response to whether the above amendments can be made, the minister advised that they did not consider it was ‘practical, appropriate or desirable for these powers to be limited in either way.’ The minister advised that the states and territories have enacted corresponding laws that apply the TG Act as part of a cooperative scheme where the Commonwealth has principal responsibility for the enforcement of regulations relating to therapeutic and vaping goods. For the purposes of effective and timely enforcement, the minister advised that state and territory officials are empowered to exercise certain powers and functions under the TG Act and officials delegated or authorised to exercise those powers may also exercise similar powers under the corresponding law of each state and territory.

2.37 In relation to limiting delegation of powers based on seniority, the minister provided a number of reasons for why it was appropriate and desirable to have flexibility in delegating powers to state and territory officials who may not have sufficient seniority, including:

• enhancing the ability of state and territory officers to monitor, investigate and enforce compliance with the TG Act;

• the operational need for the individuals running time-critical investigations to exercise such powers, which may be frequent with large volumes of active investigations;

• providing for effective engagement with state or territory officers actively involved in conducting compliance and enforcement activities under the TG Act, with the intention that these delegates will have the relevant training, skills and experience to carry out such activities;

• accommodating for differing titles and position levels that may change from time to time depending on organisational design and structure of state and territory agencies (which may include departments of state, administrative units of a territory, incorporated and unincorporated authorities); and

• existing oversight of activities by the Secretary, who may consider exercising bespoke powers to withdraw delegations or issue a binding direction that officers adhere to standard operating procedures where there is ‘less than exemplary activity’.

2.38 In relation to limiting the subdelegation of powers only to those possessing appropriate skills, qualifications and experience, the minister advised that the law in certain jurisdictions will only recognise delegations that have been made under section 57 of the TG Act that is not a subdelegation from the head of a state or territory entity.

2.39 As such, the minister stated that such a subdelegation arrangement would be ineffective. The minister further stated that the TGA is well-equipped to advise the Secretary on classes of persons whom delegations in state and territory authorities should be given, noting their responsibility in overseeing the appropriate exercise of delegated powers and functions.

Committee comment

2.40 The committee thanks the minister for this response. The committee appreciates the minister’s advice as to why flexibility may be desirable in the delegation of its powers to state and territory officials without limitations on the seniority of the official. In particular, that delegation of powers to lower levels of seniority may be required where there is an operational need, to ensure effective enforcement of regulations and to accommodate titles and position levels for differing state and territory agencies. However, the committee notes the minister’s response acknowledges that there may be situations of ‘less than exemplary activity’ being undertaken in the exercise of delegated powers. This raises concerns as to whether the proposed framework itself ensures powers are only appropriately delegated.

2.41 The committee further notes the minister’s advice on technical difficulties that may arise in relation to subdelegation arrangements for certain state jurisdictions. It also notes the minister’s advice that the TGA is well-equipped to advise the Secretary on the classes of persons whom delegations in state and territory authorities would be appropriate. Noting the advice that the TGA is well-equipped to advise as to the appropriate level of delegation, it would appear the bill itself could specify that the Secretary be satisfied that the delegate possesses appropriate skills, qualifications or experience to exercise these statutory powers or functions.

2.42 The committee requests that an addendum to the explanatory memorandum containing the key information provided by the minister be tabled in the Parliament as soon as practicable, noting the importance of these explanatory materials as a point of access to understanding the law and, if needed, as extrinsic material to assist with interpretation.

2.43 The committee draws its scrutiny concerns to the attention of senators and leaves to the Senate as a whole the appropriateness of the broad delegation of the Secretary’s powers without a limitation to those possessing the appropriate skills, qualification or experience to exercise those powers.

Strict liability offences^[96]

2.44 The TG Act currently provides for a number of offences, which this bill seeks to consolidate into a set of tiered offences.^[97] These offences include doing an act or omitting to do an act that breaches a condition of an exemption, approval or authority granted under various sections of the TG Act. The first ‘tier’ is where the act or omission has resulted in, will result in or is likely to result in harm or injury to any person, the maximum penalty is imprisonment for 5 years or 4000 penalty units or both.^[98] The second tier captures fault-based offences with the same conduct that do not result in harm or injury and carries a maximum penalty of 12 months imprisonment or 1000 penalty units or both.^[99] The third tier is in relation to the same conduct but creates strict liability offences with a maximum penalty of 100 penalty units.^[100]

2.45 In Scrutiny Digest 1 of 2025 the committee drew its scrutiny concerns to the attention of the Senate, noting that the strict liability strict liability offence under proposed subsection 32CP(3) of the bill carrying a maximum penalty of 100 penalty units was inconsistent with the Guide to Framing Commonwealth Offences.^[101]

Additional correspondence from the Minister for Health and Aged Care^[102]

2.46 The minister provided additional information regarding these penalties, noting the policy objective underpinning the inclusion of the proposed offences is to protect Australian patients from harm. The minister noted that the inclusion of strict liability, in this three-tiered offence regime, would enable the TGA to tailor enforcement action in relation to the breach of a relevant condition based on the circumstances of each case, and a requirement to prove fault may hinder the Commonwealth’s capacity to protect the public.

2.47 The minister further noted that the proposed higher maximum penalty of 100 penalty units (above the usual 60 penalty units) is justified because of the heightened potential risk to public health arising from unlawful dealings in approved biologicals, and is consistent with other strict liability penalties in the TG Act.

Committee comment

2.48 The committee thanks the minister for the additional information provided. The committee notes the minister’s advice regarding the penalties for the strict liability offences and the importance of protecting the public from harm. However, the committee reiterates that the imposition of strict liability undermines fundamental common law principles. As previously noted, under general principles of the common law, fault is required to be proven before a person can be found guilty of a criminal offence. This ensures that criminal liability is imposed only on persons who are sufficiently aware of what they are doing and the consequences it may have. When a bill states that an offence is one of strict liability, this removes the requirement for the prosecution to prove the defendant’s fault. In such cases, an offence will be made out if it can be proven that the defendant engaged in certain conduct, without the prosecution having to prove that the defendant had the intention to engage in the relevant conduct or was reckless or negligent while doing so.

2.49 The committee reiterates that the Guide to Framing Commonwealth Offences states that the application of strict liability is only considered appropriate where the offence is not punishable by imprisonment and only punishable by a fine of up to 60 penalty units for an individual.^[103] The committee agrees with this approach and does not consider penalties above this amount to be appropriate where strict liability is applied. The committee notes that the bill already provides for a tiered approach with a lower penalty when strict liability applies and a higher penalty applicable if fault has been established. The committee considers this should ensure behaviour that puts the public at risk is still subject to punishment when fault is not able to be established, but higher penalties should only be applicable once it has been established that the person to be punished intended to do, or omit to do, the specified act and was reckless as to whether the act or omission would breach a condition.

2.50 The committee reiterates its scrutiny concerns and leaves to the Senate as a whole the appropriateness of the strict liability offence under proposed subsection 32CP(3) of the bill carrying a maximum penalty of 100 penalty units (which are inconsistent with the Guide to Framing Commonwealth Offences).

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^[90] This entry can be cited as: Senate Standing Committee for the Scrutiny of Bills, Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Bill 2024, Scrutiny Digest 3 of 2025; [2025] AUSStaCSBSD 37.

^[91] Schedule 2, item 51, proposed subsection 57(1A). The committee draws senators’ attention to this provision pursuant to Senate standing order 24(1)(a)(ii).

^[92] Therapeutic Goods Act 1989, subsection 57(1A).

^[93] Proposed subsection 57(1A).

^[94] Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 1 of 2025 (5 February 2025) pp. 12–14.

^[95] The minister responded to the committee’s comments in a letter dated 18 February 2025. A copy of the letter is available on the committee’s webpage (see correspondence included with the committee’s assessment of this bill).

^[96] Schedule 2, item 78, proposed section 32CP. The committee draws senators’ attention to this provision pursuant to Senate standing order 24(1)(a)(i).

^[97] Proposed section 32CP.

^[98] Proposed subsection 32CP(1).

^[99] Proposed subsection 32CP(2).

^[100] Proposed subsection 32CP(3).

^[101] Senate Standing Committee for the Scrutiny of Bills, Scrutiny Digest 1 of 2025 (5 February 2025) pp. 14–16.

^[102] The minister responded to the committee’s comments in a letter dated 18 February 2025. A copy of the letter is available on the committee’s webpage (see correspondence included with the committee’s assessment of this bill).

^[103] Attorney-General’s Department, A Guide to Framing Commonwealth Offences, Infringement Notices and Enforcement Powers, May 2024, pp. 25–26.