This is a preliminary Bills Digest produced on an urgent basis to assist early consideration of the Bill. It provides links to relevant sources, rather than analysis, and will be replaced with a comprehensive Bills Digest in due course.

Purpose of the Bill

The purpose of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (the Bill) is to amend the Therapeutic Goods Act 1989 and other Commonwealth Acts to prohibit the importation, domestic manufacture, supply, commercial possession and advertisement of non-therapeutic and disposable vaping goods.

The Bill proposes to create ‘a single consistent framework that applies nationally to regulate the importation, domestic manufacture, supply, commercial possession and advertisement of all vapes, irrespective of nicotine content or therapeutic claims’ (p. 1). Under this framework, vapes will be regulated as therapeutic goods and will only be supplied by registered pharmacists, medical practitioners or nurse practitioners authorised to do so under state or territory law.

The Bill also introduces criminal and civil penalty provisions relating to the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods. This includes an exception for personal use relating to the possession of less than a ‘commercial quantity’ of vaping goods (with ‘commercial quantity’ to be prescribed in the regulations).

Background

Prior to the recent reforms, vapes containing nicotine have been regulated as medicines under the Therapeutic Goods Act, meaning that they cannot be imported into, manufactured in or supplied in Australia, unless registered in the Australian Register of Therapeutic Goods (ARTG), or a lawful exception to registration applies. As there are currently no nicotine vapes registered on the ARTG, nicotine vapes have been supplied to patients with a prescription as ‘unapproved therapeutic goods’ (p. 16). State/territory legislation also restricts the supply of nicotine vapes without a prescription.

Vapes which do not contain nicotine are not currently regulated under the Therapeutic Goods Act, unless represented to be for therapeutic use, although states and territories restrict the supply of these vapes, through tobacco control laws and/or public health laws (p. 17).

Vaping reforms

In November 2022, the Minister for Health and Aged Care Mark Butler announced a public consultation process on the regulation of nicotine vaping products to be run from 30 November 2022 to 16 January 2023 by the Therapeutic Goods Administration (TGA). The public consultation process was instigated largely in response to evidence of an increase in e-cigarette use by children.

Mr Butler also signalled the Government’s intention to cooperate with the states and territories to tighten the regulatory framework that applies to vaping products—both those that contain nicotine and those that do not.

Following the TGA consultation process, Mr Butler announced in May 2023 that the Government, subject to consultation with states and territories, would be proposing stronger regulation and enforcement of all vaping products, ‘including new controls on their importation, contents and packaging’.

On 1 September 2023, Commonwealth and state/territory Health Ministers ‘agreed to extend the operation of the Therapeutic Goods Act 1989 to restrict the importation, manufacture, and supply of all vapes’. Further details about these reforms were announced on 28 November 2023.

In December 2023, the Government made amendments to three regulations and nine new or revised legislative instruments under the Therapeutic Goods Act and the Customs (Prohibited Imports) Regulations 1956 to give effect to the first stage of these reforms:

From 1 January 2024:

the importation of all disposable vapes is banned, with very limited exceptions

the Special Access Scheme C (SAS C) pathway, is available to facilitate legitimate patient access to therapeutic vapes, for smoking cessation and the management of nicotine dependence

a form for importers and manufacturers of therapeutic vapes is available to notify the TGA about compliance with the relevant product standards prior to importation into Australia, or release for supply of vapes manufactured domestically (notices are required for goods imported or released for supply on or after 1 March 2024)

an application form for therapeutic vape importers is available to apply for licences and permits for importing therapeutic vapes (licences and permits are required for goods imported on or after 1 March 2024).

From 1March 2024: 

the importation of all vapes is banned unless importers have an import licence and permit from the Office of Drug Control

therapeutic vape importers and manufacturers are required to notify the TGA about compliance with the relevant product standards before importation to Australia or release for supply in Australia

the Personal Importation Scheme for vapes is closed

travellers may bring a small quantity of vapes into Australia

some changes to the quality requirements for therapeutic vapes for smoking cessation and the management of nicotine dependence, including restrictions on flavours to mint, menthol and tobacco

a new medical device standard applies to therapeutic vaping devices that were previously excluded from the therapeutic goods framework.

Further information about these reforms is set out in detail in the Impact Analysis prepared by the Department of Health and Aged Care (DoHA) published in October 2023.

Committee consideration

At the time of writing, the Bill has yet to be referred to committee.

Senate Standing Committee for the Scrutiny of Bills

At the time of writing, the Senate Standing Committee for the Scrutiny of Bills had not considered the Bill.

Policy position of non-government parties/independents

Liberal Party of Australia

The Liberal Party is yet to announce its position on the Bill. The Shadow Minister for Health and Aged Care, Anne Ruston stated that “the Coalition is still working through the details of the legislation” and expressed concerns that the current model “will not prevent children from having access to vaping products and will further drive the sale of these products to the black market”. She has previously stated that the Opposition is open to “all sensible and workable options that will prevent children from getting access and becoming addicted to vaping”. More recent media reports suggest that the Liberal Party is leaning towards supporting a regulatory model, in which vaping products are taxed and regulated in a similar manner to tobacco products. In a radio interview the Opposition Leader, Peter Dutton, stated that his instinct is to “treat it [vapes] the same as tobacco.”

The Nationals

The Nationals do not support the Bill, instead favouring a regulatory approach. In November 2023, the leader of the National Party, David Littleproud, called on the Government to “urgently regulate and tax e-cigarettes” to address increasing vaping rates. In the same media release, the Leader of the Nationals stated that:

“[t]he prescription-only model is not working and it’s time to stamp out the illegal black market and move in a constructive way towards regulation to protect children.”

…

“Licencing retailers for e-cigarettes, selling only to age 18 and above, removing flavours that are deemed attractive to children, while also ensuring harsh penalties for those illegally selling products, should be trialled, because prohibition isn’t working.”

More recent media reporting reiterates the National Party policy. An article in The Guardian quoted the Nationals leader as saying, “It’s the unanimous position of the National party that we need to regulate vapes the same as cigarettes. We need better regulation, not prohibition. Prohibition hasn’t worked.” The Nationals have previously stated that under their proposal any revenue generated through taxes on vapes would be directed towards regional healthcare.

Australian Greens

The Greens are yet to confirm their position on the Bill. Previously the New South Wales Greens have proposed regulating vaping by undertaking such measures as: legalising nicotine vapes to reduce harms and provide a pathway to quitting smoking; placing limits on nicotine levels; requiring health warnings on all vaping products and making nicotine vapes available to over 18s only. Recent reporting suggests that the Greens are not in favour of a prohibition model, with Greens leader, Adam Bandt stating, “we take a harm minimisation approach to issues concerning drugs … When it comes to other drugs, the Greens don’t support a prohibition model. We think history has suggested that prohibition models tend not to work.” The Greens have also stated that they are happy to have discussions with the government and would like to see an inquiry into the legislation.

Other parties

At this stage neither One Nation nor the Jacqui Lambie Network appear to have commented on the Bill.

Independents

At this stage many independent MPs are yet to comment on the Bill.

The member for Kooyong, Dr Monique Ryan expressed support for the legislation in a recently published opinion piece, noting that “[t]he government’s vaping legislation is important. It’s possibly too late – and it’s going to be tough to enforce – but I congratulate Mark Butler for having the courage to take on this scourge of an industry.”

Dr Sophie Scamps, member for Mackellar, does not appear to have commented on the Bill, but has previously called for stronger government action in relation to vaping. Kate Chaney, member for Curtin, Allegra Spender, member for Wentworth, Kylea Tink, member for North Sydney and Zali Steggall, member for Warringah have all previously spoken about strengthening regulations in relation to vaping.

Position of major interest groups

A number of public health organisations, including the Australian Medical Association (AMA), the Royal Australian College of General Practitioners (RACGP), the Cancer Council, the Lung Foundation Australia and the Heart Foundation strongly support the legislation and have called on MPs to support it. The president of the AMA stated that “this is a national health crisis that must be stopped in its tracks, and the only way to do that is to stop the retail sale of vapes and give people the help they need to kick this dangerous habit by moving to a prescription only model”. While the Cancer Council noted that “Children and young people are…around three times more likely to take up tobacco smoking compared to young Australians who have never vaped.”

The CEO of the Australian Association of Convenience Stores, Theo Foukkare, has expressed concern that the prescription model in the Bill may lead to an increase in the black market supply of vaping products. Concerns about the effect of the legislation on the black market have also been raised in some media reports. For example, James Martin and David Bright, ‘Australia’s restrictive vaping and tobacco policies are fuelling a lucrative and dangerous black market’, The Conversation, 12 March 2024.

Media reports

Melissa Davey, ‘Doctors urge politicians not to be swayed by 'misleading' comments on vaping ban from industry-funded lobbyists’, The Guardian, 21 March 2024.

Natasha Robinson, ‘Vapes crackdown ‘to ignite black market’’, The Australian, 16 March 2024.

Wayne Hall, ‘For the new vape laws to succeed, these 3 things need to happen – or users may look to the illicit market’, The Conversation, 24 January 2024.

Becky Freeman, ‘From today, new regulations make it harder to access vapes. Here’s what’s changing’, The Conversation, 1 January 2024.

Janet Hoek and Anna DeMello, ‘Why tobacco companies’ warnings about a black market are inflated and misleading’, The Conversation, 3 May 2023.

Financial implications

According to the Explanatory Memorandum, ‘the Government will provide $82.0 million over four years from 2023–24 to support the vaping reforms, awareness raising and enforcement activities’ (p. 7). This funding will include:

• $56.9 million over two years from 2023–24 to the TGA 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.

This measure builds on the 2023–24 Budget (p. 154) measure titled Vaping Regulation Reform and Smoking Cessation Package (see the Parliamentary Library Budget Review which discusses these measures).

Statement of Compatibility with Human Rights

As required under Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed the Bill’s compatibility with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of that Act. The Government considers that the Bill is compatible.[1]

Parliamentary Joint Committee on Human Rights

At the time of writing, the Parliamentary Joint Committee on Human Rights had not considered the Bill.