Katy Gallagher (ACT, Australian Labor Party, Minister for the Public Service) Share this | Hansard source

I move:

That this bill be now read a second time.

I seek leave to have the second reading speech incorporated in Hansard.

Leave granted.

The speech read as follows—

Today, I introduce the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024.

The Bill builds on Labor's long history of pioneering tobacco control reforms, harking back 50 years ago to when the Whitlam Government introduced the first restrictions on tobacco advertising. That legacy continued with the introduction of Australia's world-leading tobacco plain-packaging reforms just over 10 years ago, and again with the Albanese Government's push to reignite the fight against tobacco, with the Public Health (Tobacco and Other Products) Act 2023, which was passed in Parliament last year.

Tobacco plain packaging was bold policy achieved in the face of some often savage legal and rhetorical assault. It was imaginative policy. And it was world-leading policy: 26 countries have followed our lead and introduced their own such laws. It's a policy that has saved lives and will continue to save lives. When plain packaging was introduced, around 16% of Australian adults smoked. Today, just over 10% do.

But all that progress could be undone, if we do not urgently address the threat posed by a new public health menace: vaping.

E-cigarettes and vapes were sold to governments and communities around the world as a therapeutic good: a product that could help hardened smokers—usually people in their 40s or 50s—to quit smoking and kick the habit.

If vapes are therapeutic goods then it is entirely appropriate that Australia should regulate them as therapeutic goods, instead of allowing them to be sold alongside candy bars in convenience stores, often down the road from schools.

Importantly, this Bill does not take away the ability for patients to legitimately access therapeutic vapes to help them quit smoking or manage their nicotine dependence, if that is deemed to be clinically appropriate for that patient.

The Bill affirms Australia's commitment to its international obligations as a party to the World Health Organization Framework Convention on Tobacco Control. Under this Convention, parties are obliged to develop and implement effective policies to not only to prevent and reduce tobacco consumption and exposure, but also to prevent and reduce nicotine addiction.

It is critical to introduce new safeguards in accordance with this commitment, to prevent the current and future public health risks associated with vaping.

The Bill takes strong action to ban the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods, except in limited circumstances. It is a necessary step to address the growing risk posed by vaping in Australia, particularly to youth and young adults, while preserving legitimate patient access to therapeutic vaping goods for smoking cessation and the management of nicotine dependence, where clinically appropriate.

These measures complement changes that have been instituted at the border. Together, these are intended to arrest and reverse the increasing rates of vaping, and to prevent long term adverse effects on population health.

The reforms in this Bill are world-leading. Vaping is a very serious public health menace and the rapid rise in vaping among young people is creating a whole new generation of persons with nicotine dependence in our schools and communities. It poses a major threat to population health and Australia's success in tobacco control, and that is why this Bill is so critical to addressing these challenges now. The global health community is watching us closely.

The highly addictive nature of nicotine, the sophisticated marketing to vulnerable populations, and the direct inhalation of substances into the lungs, mean that risks to population health associated with vaping can be severe. Numerous studies highlight concerns about potential adverse effects, including impact on adolescent brain development, worsened pregnancy outcomes, cardiovascular disease, respiratory disease and cancer.

This is not surprising, as vapes have been found to include over 200 chemicals, including listed poisons, heavy metals such as nickel and chromium, and chemical by-products produced during heating such as formaldehyde, nitrosamines, acetone, and acrolein. Some of these chemicals are used in weed killer, nail polish remover and even to embalm dead bodies. A range of other health risks are also associated with vape use, including severe burns, poisoning and seizures.

The evidence is clear: people who have never smoked, and who use vapes, are more likely to take up cigarette smoking than those who do not.And dual use of vaping and tobacco products may even result in worse health outcomes compared to smoking alone.

Perhaps most worryingly, the long-term health risks of vaping are not yet fully known. Nicotine vapes may worsen mental health conditions, and amplify stress, anxiety and depressive symptoms. Parents, teachers and doctors are reporting that nicotine dependence is impacting learning behaviours and well-being in schools. In addition, the Australian Dental Association warns that vaping may be setting the next generation up for a raft of oral health issues.

The latest national data show that 1 in 6 (16%) secondary school students aged 12 to 17 years reported recent vaping in 2022/23—a four-fold increase since the previous survey from 2017 (4%). These statistics are alarming and support the need for strong, decisive and urgent action.

Vapes are being deliberately marketed and supplied to young Australians, with colours, flavours and packaging specifically designed to attract them. Vaping goods are aggressively promoted by the vaping industry in online advertising and other youth-focused media channels. Many vapes are deliberately mislabelled as containing 'no nicotine' or 'zero nicotine' or even unlabelled to avoid detection and seizure. However, the Therapeutic Goods Administration has reported that approximately 90% of all tested vapes are found to contain nicotine, no matter what appears on the label.

Further, we know that a significant number of vape stores around Australia are located within walking distance of schools—in some states it is as high as 9 in 10 stores—and worryingly, around one in six high school students is now a regular vaper. Allowing these trends to continue is not an acceptable option. This is a crisis that deserves our national attention.

The Bill appropriately responds by implementing the second stage of the Government's vaping reform measures. The first stage commenced earlier this year through amendments to regulations. The importation of disposable single use vapes, irrespective of nicotine content or therapeutic claims, was banned on 1 January 2024, subject to very limited exceptions. The importation of all other vapes was banned on 1 March 2024, unless certain requirements are met in relation to those vapes, including licences and permits, and pre-market notifications under the Therapeutic Goods Act. These reforms focus on turning off the tap at the border as a necessary first step to combat supply.

The second stage, to be effected by this Bill, will regulate the importation, domestic manufacture, supply, possession and advertisement of all vapes under the Therapeutic Goods Act. This is achieved by extending the scope of the Therapeutic Goods Act to all vapes, not simply therapeutic vapes.

The Bill institutes changes to ban non-therapeutic vapes and ensure that therapeutic vapes are supplied through pharmacy settings. Advertisements targeted at young people will be banned. Disposable vapes will be banned and widespread promotion and availability will be limited.

The Bill will be complemented by changes to regulatory settings for therapeutic vapes to increase quality standards, significantly reduce flavours and introduce plain packaging. Similar safeguards already apply to other prescription medicines, including those for smoking cessation and the management of nicotine dependence.

Because let us not be in any doubt: vapes were sold to the Australian community as therapeutic goods, to aid those seeking to quit cigarette smoking. And so, it is entirely appropriate to regulate them as we do any other therapeutic goods—through regulation that simultaneously ensures legitimate access and provides sound public protection.

The Government is not taking away the ability for patients to legitimately access vaping goods for smoking cessation or the management of nicotine dependence, where clinically appropriate. The reforms simply ensure that vapes are only accessed under the clinical supervision of a medical or nurse practitioner, to provide an opportunity for users to receive appropriate advice on the risks associated with vaping, the benefits of not smoking, and any up-to-date health advice as part of their usual care.

Deliberately mislabelling vapes to conceal the presence or content of nicotine will no longer be a means for suppliers to avoid compliance and enforcement. It will be easier for authorities to prove that vapes are unlawful and to enable their seizure. Importantly, there will be no legitimate supply through vape shops, convenience stores or other retail outlets, such as petrol stations or milk bars.

The reforms to strengthen the regulation of all vaping goods irrespective of nicotine content was recommended in the National Tobacco Strategy 2023-2030. The Strategy was developed in consultation with a wide range of stakeholders and was endorsed by all Commonwealth, state and territory health ministers in 2023.

The Bill provides a single consistent framework that will apply nationally to the regulation of all vapes. The federal cooperative scheme between Commonwealth, states and territories for the regulation of therapeutic goods will be extended to vaping goods to ensure comprehensive controls. The scheme is achieved through the application of corresponding laws enacted in each state and territory, with Western Australia having recently introduced legislation to the Parliament of Western Australia to enact their own corresponding law.

The extension of the Therapeutic Goods Act to vapes is appropriate and necessary in the circumstances and will facilitate a national approach by enabling all jurisdictions to use the same legislation.

Under the Bill, there are significant penalties for importing, manufacturing, supplying, possessing and advertising vapes except in certain circumstances. Consistent with the federal cooperative scheme, the Commonwealth will take responsibility for enforcing importation, manufacture, sponsor supply and advertisement. The states and territories will take responsibility for enforcing wholesale supply, retail supply and commercial possession. The Australian Border Force will lead enforcement at the border.

The Therapeutic Goods Administration and state and territory officers will exercise powers and functions, in concert with police authorities as required, and particularly when organised crime is involved.

Advertising of vapes to the public will be banned in almost all instances. Offences and civil penalties will apply to this conduct and operate in conjunction with bans on advertising in the new tobacco control laws passed in Parliament last year.

Bans on the supply of vapes outside of pharmacy settings go to the heart of these reforms and will be principally enforced by the states and territories, with the support of the Commonwealth.

For the first time under the Therapeutic Goods Act, there will be offences and civil penalties for the commercial possession of vapes. These are aimed at unlawful retailers and operators of warehouses and other persons with significant quantities of vapes who deny having been involved in supply. These are tiered offences, with higher maximum penalties depending on the quantities of vapes possessed.

The new ban on possession includes an exception for personal use, including by young Australians who are deliberately being targeted by an industry determined to make a profit. This Bill is not about penalising persons who are using vapes, whether adults or children.

The focus of the Bill is to criminalise the illicit importation, manufacture, supply, advertisement and commercial possession of vapes. This is needed to protect young Australians in particular.

The penalties for breaching the new requirements are significant. These are designed to ensure that the reforms provide a strong deterrence from engaging in conduct that may harm Australians.

The Government knows that some people will say that the reforms will simply grow the black market. However, effective enforcement has been hampered by the current regulatory settings.

The Bill will address the methods that certain operators are using to import, advertise and supply nicotine vapes illegally. Strengthening the regulation of all vapes, through enhancing border controls, banning all disposable single use vapes and ending the supply of vapes outside of pharmacy settings, will make it easier to identify and disrupt the illicit supply of vapes and take effective enforcement action.

Strengthened enforcement activities across all levels of the supply chain will also combat the black market. To support the implementation and enforcement of these reforms, the Government is providing an additional $25 million to the Australian Border Force and $56.9 million to the TGA over two years. And all states and territories are committed to sharing and increasing compliance action and supporting a national enforcement approach.

The vaping reforms complement a wider set of actions being taken by the Government. This includes $63.4 million for new public health information campaigns to prevent and reduce the use of tobacco and e-cigarettes. This includes a dedicated Youth Vaping Education campaign, the first phase of which launched in February, with future phases planned to start later this year; and the National Tobacco and E-Cigarette campaign, which is planned to launch mid-year. These campaigns together will ensure all Australians are aware of the risks associated with vaping, and the supports available to help them quit.

The measures in this Bill reflect evidence that a comprehensive range of demand and supply reduction measures can be highly effective in changing drug related attitudes and behaviours. Reforms recommended by the TGA and implemented in 2018 to make codeine a prescription only medicine are one example of this. Evidence showed that, after the codeine reforms were implemented, rates of codeine misuse and sales reduced substantially.

In the meantime, a range of support services continue to be available nationally to help people quit smoking and the use of e-cigarettes. This includes programs run through state and territory health services and Aboriginal Community Controlled Health Services, and the provision of quit advice and support through Quitline counsellors and other health professionals, such as GPs, pharmacists and specialists. It also includes 'first line' smoking cessation products that continue to be available, including medicines and patches that are subsidised on the Pharmaceutical Benefits Scheme.

The Government is also providing $29.5 million to expand specialised programs and services to support Australians to quit smoking and vaping, and $141 million to extend and widen the Tackling Indigenous Smoking program to reduce both vaping and smoking among First Nations people.

We must slow and reverse the importation, manufacture, supply and advertisement of vapes in Australia, other than for legitimate, therapeutic use. We know that the job will be difficult, but so much great work is already underway to safeguard the health of Australians from the risks of vaping. The reforms introduced by this Bill will further this work and critically empower authorities to stop the spread of vapes endangering the health of young Australians.

It is just over 50 years since Labor introduced the first restrictions on tobacco advertising, and just over 10 years since we introduced Australia's world leading plain packaging laws.

As Parliamentarians in this place today, we all have the opportunity and responsibility to act now, to safeguard the health of young Australians for generations to come.

How will history judge us 10 or 50 years from now, if—instead of acting—we equivocate: squandering this opportunity and ignoring our responsibility?

How will our children and grandchildren judge us, then?

Let us lead the world again, once more—for the sake of our children and their children to come.

I commend the Bill.

Debate adjourned.