Supplementary Explanatory Memorandum
(Circulated by authority of the Minister for Health and Aged Care the Hon Mark Butler MP)AMENDMENTS TO THE THERAPEUTIC GOODS AND OTHER LEGISLATION AMENDMENT (VAPING REFORMS) BILL 2024
OUTLINE
The proposed Government amendments would amend the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (the Bill).
The amendments respond to queries from the Senate Standing Committee for the Scrutiny of Bills, as well as concerns raised during the Senate Community Affairs Legislation Committee Inquiry on the Bill and separately by individual Senators in their considerations.
Review of operation of amendments
The proposed Government amendments insert a requirement for an independent review of measures introduced by the Bill and associated legislative instruments to commence no later than 1 July 2027.
This requirement addresses the concerns raised in the additional comments from Coalition Senators to the Senate Community Affairs Legislation Committee Inquiry's Report on the Bill, that the Government has no quantifiable measures of success.
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This review provides an opportunity for the vaping reforms to be monitored and evaluated. Additionally, conducting such a review is consistent with the advice in the impact analysis on the proposed reforms to the regulation of vapes published on the Office of Impact Analysis website:
www.oia.pmc.gov.au
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Retail possession offence and civil penalty provisions
The proposed Government amendments replace the offence and civil penalty provisions in the Bill for the possession of less than a commercial quantity of vaping goods (proposed section 41QD) with new, more targeted, offence and civil penalty provisions. The new provisions prohibit the possession of less than a commercial quantity of vaping goods by a retailer in retail premises in Australia. The purpose is to target deliberate dealings in small quantities of unlawful vaping goods by retailers. Consumers and individual users are not covered by these prohibitions.
An exception has also been inserted in the offence and civil penalty provisions for the possession of more than a commercial quantity of vaping goods (new section 41QC) if the vaping goods are for personal use. This amendment is to further reinforce that the purpose of the measures is not to penalise individual users.
Consent scheme
The Bill amends proposed a new section 41RC to require the Secretary to comply with decision-making principles (if any) when exercising the power to consent to applications to manufacture, supply or possess vaping goods. The proposed Government amendments would empower the Minister to make a legislative instrument to determine decision-making principles that the Secretary must comply with in making a decision to grant consent. This legislative instrument would be subject to Parliamentary scrutiny and disallowance.
The provision would respond to concerns raised by the Senate Standing Committee for the Scrutiny of Bills about the conferral of a broad discretionary power on the Secretary.
Merits review of enforceable directions
The Bill provides that the Secretary may give directions to a person in prescribed circumstances. The proposed Government amendments specify that a person to whom directions are given may seek merits review of the decision by the Minister and the Administrative Appeals Tribunal. This responds to a query from the Senate Standing Committee for the Scrutiny of Bills about the availability of merits review.
Forfeiture
The proposed Government amendments ensure that the new forfeiture powers apply to vaping goods that were seized under warrant, and are in an authorised person's custody, immediately before commencement of those powers. This will assist with the safe and orderly disposal and destruction of significant numbers of seized unlawful vaping goods.
Advertising provisions
The proposed Government amendments would remove the proposed Ministerial power to make a legislative instrument excluding advertisements to health practitioners, and certain other classes of persons, from the operation of the new advertising controls. This amendment addresses the concerns raised by certain Senators and stakeholders in the Senate Community Affairs Legislation Committee Inquiry about the breadth of the exclusion in light of aggressive marketing practices of certain sponsors.
Offence and civil penalty provisions concerning breach of a condition
The proposed Government amendments would update the penalty regime in the Therapeutic Goods Act 1989 (TG Act) for breach of a relevant condition of exemption, approval or authority to import or supply a medicine or medical device not included in the Australian Register of Therapeutic Goods (Register).
Supply of therapeutic goods by pharmacists with or without prescription
To facilitate greater patient access to therapeutic vaping goods under health practitioner supervision, the proposed Government amendments would down schedule nicotine in therapeutic vaping goods from Schedule 4 (prescription only medicines) to Schedule 3 (pharmacist only medicines) to the current Poisons Standard in specified circumstances with appropriate safeguards.
These amendments would allow a pharmacist to supply certain therapeutic vaping goods to an adult without a prescription from a medical or nurse practitioner provided certain conditions are met, including that the pharmacist provides professional advice to the patient on alternative cessation supports and therapies. The Government amendments would also propose to amend two other instruments to support the down scheduling of nicotine in certain therapeutic vaping goods.
Financial Impact Statement
There are no financial implications arising from these amendments for the Government's budget.