Senate

Replacement Explanatory Memorandum

(Circulated by authority of the Minister for Health and Aged Care, the Hon Mark Butler MP)

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

THERAPEUTIC GOODS AND OTHER LEGISLATION AMENDMENT (VAPING REFORMS) BILL 2024

The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (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.

Overview of the Bill

The Bill will implement the second stage of the Government's vaping reform measures by amending the Therapeutic Goods Act 1989 (the TG Act). The first stage of the Government's vaping reform measures comprised amendments to the Therapeutic Goods Regulations 1990 (the TG Regulations), Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) and Customs (Prohibited Imports) Regulations 1956 (the CPI Regulations). These amendments commenced operation on 1 January 2024.

In restricting the availability of, and access to, vaping goods in Australia, the Bill is intended to address the high levels of uptake of vaping among youth and young adults, the health risks that vapes pose to human health, the impacts of vaping on the initiation, continuation and cessation of tobacco product use, and the practice of dual use with conventional tobacco products. Despite the new restrictions and prohibitions applying to the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods, the Bill preserves legitimate patient access to therapeutic vaping goods for smoking cessation and the management of nicotine dependence under appropriate health practitioner supervision. All therapeutic vaping goods, including vaping goods that do not contain nicotine, are to be supplied in Australia, only by registered pharmacists, medical practitioners or nurse practitioners authorised to do so under state or territory law.

The public health problem

Vaping is rapidly increasing in Australia, particularly among youth and young adults. The latest available trend data shows that among young people aged 14 years and over, current use of an e-cigarette, defined as used at least once in the month prior to being surveyed, increased from 2.5% to 8.9% between 2020 and 2023. The increase was even more marked among people aged 18-24 years old, increasing from 5.6% in 2020 to 19.8% in 2023. These findings reinforce a widespread and serious concern among public health policy makers and practitioners at the increasing marketing and use of vaping goods.

The Australian Government introduced regulatory changes in October 2021 to clarify that persons require prescriptions from a health practitioner for the lawful supply of products containing nicotine for human use except in certain circumstances, such as nicotine replacement therapies for oromucosal or transdermal administration for smoking cessation or tobacco smoking. These changes were intended to prevent youth and young adults from vaping, while allowing current smokers to access therapeutic vaping goods for smoking cessation under appropriate medical supervision. However, increasing rates of vaping among youth and young adults suggest that these reforms are not meeting their objectives. Normalisation of vaping is undermining population health and has the potential to disrupt the significant achievements Australia has made to date in tobacco control. Further measures were therefore needed to curb the increase in the rates of vaping, and to control the availability of vaping goods that are being accessed by young people.

The reforms implemented in the Bill align with the Government's broader objective to significantly reduce the use of tobacco and nicotine products in Australia by 2030, as outlined in the National Tobacco Strategy 2023-2030.

Objectives

The Bill provides for the establishment and maintenance of a national system of controls relating to the regulation of vaping goods that are imported into Australia, manufactured in Australia, supplied in Australia or exported from Australia. This is to address the health risks posed by vaping, while ensuring therapeutic vaping goods remain available, where clinically appropriate, to patients in pharmacy settings.

Human rights implications

The Bill engages the following human rights:

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the right to health under Article 12 of the International Covenant on Economic Cultural and Social Rights (ICESCR);

•

the right to life under Article 6 of the International Covenant on Civil and Political Rights (ICCPR);

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the obligation to ensure the survival and development of children under Article 6(2) of the Convention of the Rights of the Child (CRC);

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the obligation to protect children from illicit use of narcotic drugs and psychotropic substances under Article 33 of the CRC;

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the right to privacy under Article 17 of the ICCPR;

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the right to freedom of expression under Article 19(2) of the ICCPR;

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the right to a fair hearing under Article 14(1) of the ICCPR;

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the right to the presumption of innocence under Article 14(2) of the ICCPR;

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the right to be free from self-incrimination under Article 14(3)(g) of the ICCPR;

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the right not to be tried or punished again for an offence for which a person has already been finally convicted or acquitted under Article 14(7) of the ICCPR.

The right to health

The Bill engages the right to health in Article 12 of the ICESCR. Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standard of physical and mental health and includes an obligation on state parties to take reasonable measures within available resources to progressively secure broader enjoyment of the right.

In General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12) (2000), the United Nations Committee on Economic, Social and Cultural Rights states that health is a 'fundamental human right indispensable for the exercise of other human rights', and that the right to health is not to be understood as the right to be healthy, but includes the right to a system of health protection which provides equal opportunity for people to enjoy the highest attainable level of health.

Vaping has been associated with a range of short-term health risks, and its long-term health effects are still unknown. Marketing of vaping goods and use in the community has increased rapidly in recent years, particularly among young people, and pose a major risk to population health and Australia's success in tobacco control.

The latest available trend data shows that among young people aged 14 years and over, current use of an e-cigarette, defined as used at least once in the month prior to being surveyed, increased from 2.5% to 8.9% between 2020 and 2023. The increase was even more marked among people aged 18-24 years old, increasing from 5.6% in 2020 to 19.8% in 2023. These findings reinforce a widespread and serious concern among public health policy makers and practitioners at the increasing marketing and use of vapes.

The health risks of vaping are substantial. A review of global evidence published in April 2022 found evidence that vaping by non-smokers results in dependence and conclusive evidence that vaping can cause respiratory disease, severe burns, poisoning and seizures. Further, there is strong and consistent evidence that adolescents and young adults who vape are up to three times more likely to take up smoking, compared to those who do not, and the long-term health risks of vaping are not yet known. Importantly, the long-term health effects of vaping are not known, and public health experts are concerned they could be of a similar magnitude to those resulting from smoking tobacco.

The Bill takes positive steps to promote the right to health by restricting access to vaping goods, except where clinically warranted through pharmacy (and medical) settings.

Bans on the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods are intended to arrest and reverse the increasing uptake of recreational vaping, especially amongst youth and young adults by banning the domestic supply of vaping goods outside the pharmaceutical supply chain.

Allowing patient access to therapeutic vapes strikes an appropriate balance between the health concerns posed by vaping and the need to provide legitimate patient access to support Australians to quit smoking or manage nicotine dependence.

Ensuring vaping goods are only accessed under appropriate health practitioner supervision provides an opportunity for users to receive appropriate advice from a health professional on the appropriateness of therapeutic vaping goods in relation to the condition that is being treated, the availability of other therapeutic goods to treat the specified condition, the risks associated with their use and the benefits of not smoking. This will enable Australians to make informed decisions concerning their health.

In parallel to the introduction of the Bill, cessation services in Australia will be enhanced to ensure support for people who seek assistance to stop vaping.

The Bill promotes aspects of the right to health under Article 12 of the ICESCR that relate to recognising the right of everyone to enjoy the highest attainable standard of physical and mental health.

The right to life

By seeking to reduce the incidence of vaping, thereby reducing the associated health risks and controlling access to vapes, the measures contained in the Bill promote the right to life.

Nicotine, which is contained in most vapes and e-liquids, is highly poisonous and intentional or unintentional ingestion can lead to nicotine poisoning or death. An average 2-year-old child would experience potentially lethal effects by ingesting as little as 0.8 ml of a 100 mg/ml nicotine e-liquid. ^[10]

Vape use has been associated with a number of short-term health risks, including death from lung injury. The long terms health consequences of vaping are unknown and public health experts are concerned that those risks could be of a similar magnitude to those resulting from smoking tobacco.

Further, vaping is a strong predictor of future tobacco use for youth and young adults, including for those who would otherwise be unlikely to take up conventional smoking. ^[11] Vaping also mimics behavioural and sensory aspects of smoking, which makes the transition to combustible smoking more likely. ^[12]

Tobacco use causes more deaths than any other behavioural risk factor. Up to two thirds of deaths in tobacco smokers can be attributed to smoking, and long-term smokers die an average of 10 years earlier than nonsmokers. Exposure to second-hand smoke is also a cause of preventable death and disability in both adults and children. Tobacco use and exposure among pregnant people and their babies is one of the most prevalent preventable causes of infant death and illness and of adverse pregnancy outcomes including preterm birth and still-birth. ^[13]

Tobacco smoking by youth and young adults has immediate adverse health consequences and accelerates the development of chronic diseases across the full life course. It can lead to nicotine dependence that causes young people to continue smoking for longer, causing increased physical damage. In addition, quitting smoking at any age reduces the risk of premature death and improves quality of life.

The Bill promotes the right to life by implementing measures to prohibit access to vaping goods unless clinically appropriate under health practitioner supervision.

Obligation to ensure the survival and development of children

Article 6(2) of the CRC requires state parties to take measures to ensure the survival and development of children to the greatest extent possible.

Vaping goods pose a particular risk to children. The variability in concentration and toxicity of active ingredients, particularly nicotine, but also other toxic substances, increases the risk that children who consume these ingredients may ingest a fatal dose or suffer severe adverse effects. In addition, vapes contain flavours designed to entice children, and for which the adverse effects are unknown. Although these flavours may be safe when ingested, their safety profile when inhaled directly into the lungs is not established.

Vapes can contain harmful chemicals that are known to cause irreversible lung damage and may also have chronic long-term effects. In addition, it appears that most products on the domestic market contain, or are likely to be used in conjunction with, nicotine. This is the case even where no nicotine is indicated on the label of the product, if any label exists.

Vaping goods are frequently designed to look like other innocuous and ubiquitous objects such as pens, USB devices, lip gloss, toys and sippy cups. The designs use colours, illustrations and cartoons that are deliberately attractive to children and may lead to misconceptions that vaping goods are harmless when this is not the case.

To the extent that restricting the importation, domestic manufacture and supply of vaping goods may adversely affect the health of persons (including young persons) who are already addicted to nicotine, the prohibition in this amendment will not extend to those who are legitimately prescribed vaping substances that contain nicotine for the management of that dependence, in accordance with clinical guidelines, under appropriate health practitioner supervision.

In summary, the vaping reform will promote the survival and development of children to the greatest extent possible and where the measure may limit a child's rights, the limitation is necessary in order to protect the Australian community, in particular children, from the risks to health that misuse can cause, and is reasonable and proportionate as access to vaping substances is still available where there is a legitimate medical need.

Obligation to protect children from illicit use of narcotic drugs and psychotropic substances

Article 33 of the CRC specifically requires state parties to take appropriate measures to protect children (up to the age of 18) from the illicit use of narcotic drugs and psychotropic substances. Although vapes are not specifically listed in the relevant international treaties banning narcotic drugs and psychotropic substances, the substances in unregulated vapes are not known and on occasion have been found to include a range of drugs. Further, the Committee on the Rights of the Child has recognised that Article 33 has a broad application and may impose obligations on state parties to protect children from the use of substances that are not listed in the Conventions, such as alcohol and tobacco. The Committee therefore urges state parties to regulate or prohibit information on and marketing of substances, such as alcohol and tobacco, particularly when the information or marketing targets children and adolescents.

The new controls on the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods will promote the protection of children from exposure and easy access to addictive and unsafe vaping goods. Under the reforms, vaping goods are only intended to be accessed by legitimate patients through limited supply channels involving registered pharmacists, medical practitioners and nurse practitioners authorised under state or territory law to supply prescription medicines. This will reduce the potential for vapes to be supplied unlawfully to children.

The controls placed on the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods are therefore an important tool for promoting children's rights to be protected from nicotine dependence and exposure to other dangerous substances, including potentially narcotic drugs and psychotropic substances, in vaping goods. These measures, by restricting the importation, domestic manufacture and supply of untested and potentially dangerous substances contained in vaping goods will assist in preventing their supply to, and access by, youth and young adults.

These measures seek to promote the requirement to protect children from exposure to, and use of, narcotic drugs, psychotropic substances and other harmful substances that may be contained in vaping goods to the greatest extent possible. The limitation is reasonable and proportionate as access to vaping goods is still available where there is a legitimate therapeutic need under appropriate medical supervision.

The right to privacy

The Bill engages the protection against arbitrary or unlawful interference with privacy. Article 17 of the ICCPR prohibits arbitrary or unlawful interference with an individual's privacy, family, home or correspondence, and protects a person's honour and reputation from unlawful attacks. The right to privacy can be limited to achieve a legitimate objective where the limitations are lawful and not arbitrary. For interference with the right to privacy to be permissible, the interference must be authorised by law, be for a reason consistent with the ICCPR and be reasonable in the circumstances. The United Nations Human Rights Committee has interpreted the requirement of 'reasonableness' as implying that any interference with privacy must be proportionate to a legitimate end and be necessary in the circumstances.

The Bill provides for the collection, use and disclosure of information, which may include personal information. These provisions engage and may limit the right to privacy. The proposed information gathering, reporting and release measures are reasonable, necessary and proportionate to a legitimate objective of supporting the effective implementation of the vaping reforms for a public health objective.

Consent scheme

The Bill amends the TG Act to introduce a consent scheme under section 41RC to allow persons who do not have a licence or authority under the TG Act or state and territory laws to lawfully manufacture, possess or supply vaping goods. Persons that can be granted consent may include:

(a)

persons transporting vaping goods within a state or from one state to another;

(b)

persons storing vaping goods for supply to a wholesaler or a pharmacist; and

(c)

pharmacists compounding or manufacturing different vaping goods.

A person who has been granted a consent under new section 41RC will be able to lawfully use the consent as a defence to the manufacturing, supply and possession offences or civil penalty contraventions under new Chapter 4A of the TG Act.

These provisions engage and may limit the right to privacy. The proposed information gathering and reporting measures are reasonable, necessary and proportionate to a legitimate objective of supporting the objects of the vaping reform to promote and support public health objectives.

If personal information is provided in a report to the Secretary, the collection, storage, use and disclosure of such personal information would be subject to the requirements and limitations in the Privacy Act 1988. The Department of Health takes seriously its obligations and compliance with requirements applying to personal information that it holds and collects under the Privacy Act 1988.

Investigations, entry to premises, investigations, seizure and forfeiture

The Bill introduces new offences and civil penalty contraventions in relation to the importation, manufacture, supply, commercial possession and advertisement of vaping goods. In addition, a new section 52AAA is introduced in the Bill in which vaping goods seized under a warrant under section 50 of the TG Act in specified circumstances are forfeited to the Commonwealth without any court order, and conviction or contravention of a civil penalty provision being established through court proceedings.

Although new offences and civil penalty contraventions are introduced in the TG Act by the Bill, individuals are protected against arbitrary interference with privacy. In general the entry, search and seizure powers cannot be exercised without the person affected being fully informed, a voluntary consent of the occupier of the premises being provided by the affected person, or the presence of a prior authorisation in the form of a warrant. There are exceptions to these in circumstances where an authorised person exercises entry and seizure powers in the interests of public health to avoid an imminent risk of death, serious illness or serious injury (refer to section 46B of the TG Act). The powers of an authorised person under Part 6-2 of the TG Act relating to entry, search and warrant remain unchanged.

The offence and civil penalty related warrants issued under section 50 of the TG Act are only issued by an issuing officer if satisfied, by information on oath that there are reasonable grounds for suspecting that there is, or there may be within the next 72 hours, in or on the premises evidential material in respect of an offence against the TG Act, in respect of a contravention of a civil penalty provision or in respect of both. An issuing officer must not issue a warrant unless the authorised person or some other person has given to the issuing officer, either orally or by affidavit, such further information as the officer requires concerning the grounds on which the issue of the warrant is being sought (subsection 50(3) refers). Such constraints on this power ensure adequate safeguards against arbitrary limitations on the right to privacy in the issuing of warrants.

If entry is authorised by warrant, the authorised person must provide a copy of the warrant to the occupier of the premises. This provides for the transparent utilisation of the powers and mitigates arbitrariness and risk of abuse.

Part 6-2 of Chapter 6 of the TG provides for constraints on the exercise of the powers by authorised persons and therefore limits the susceptibility to arbitrary use or abuse and ensures that their use is reasonable and proportionate in the circumstances.

Forfeiture of goods seized under specified circumstances for the purposes of section 52AAA will only be those seized under a warrant granted under current section 50 of the TG Act. This provision engages the right to privacy in Article 17 of the ICCPR. To the extent that it may limit this right, the limitation is provided for by law. The forfeiture of specified things or goods are subject to judicial review and can be challenged by the person who owns or possess the goods.

As such, any interference with an individual's privacy that may be said to be enabled under the TG Act to enforce the regulation of the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods would not be an arbitrary inference within the meaning of Article 17 of the ICCPR.

Accordingly, the amendments made in relation to the bans on importation, domestic manufacture, supply, commercial possession and advertisement are reasonable, necessary and proportionate to achieving the legitimate objective of the new regulatory framework applying to vaping goods in Australia.

The right to freedom of expression

The Bill contains prohibitions on the advertising of vaping goods (new Part 5-1A). Article 19(2) of the ICCPR engages the right to freedom of expression, which extends to any medium, including written and oral communications, the media, public protest, broadcasting and artistic works, and may include commercial advertising.

Article 19(3) of the ICCPR states that public health is a basis on which the right to freedom of expression can be limited. This right may be limited as provided for by law and when necessary for respect of the rights or reputations of others, for the protection of national security, public order, or of public health or morals. Limitations must be prescribed by legislation necessary to achieve the desired purpose and proportionate to the need on which the limitation is predicated.

The Bill contains prohibitions on the advertising of vaping goods in the new Part 5-1A. These prohibitions engage and may limit the right to freedom of expression, which is protected by Article 19(2) of the ICCPR. However, these restrictions are directed to the desired purpose of reducing illegitimate and non-therapeutic vaping and the related health risks. This is a legitimate public health objective and accordingly the prohibition is necessary to achieve the desired purpose and proportionate to the need on which the limitation is predicated.

Legitimate objective: measure is justified under a permitted limitation

The right to freedom of expression is not absolute. It carries special responsibilities and may be restricted on several grounds. Article 19(3) of the ICCPR expressly states that the right to freedom of expression may be subject to limitations necessary for the protection of public health. The limitation (if any) of the right to freedom of expression in the Bill aims to achieve a legitimate objective – the protection of public health – by contributing to efforts to reduce vaping rates and the associated health risks. This is of critical importance in relation to the advertising of vaping goods to youth and young adults by means of retail websites and social media. The Bill aims to achieve this by prohibiting the direct and indirect promotion of vaping goods subject to very limited exceptions, including patient consultations and authorisations given under new section 42DZC.

Reasonable: measure will be effective to achieve the desired ends

The proposed reforms include a comprehensive advertising ban of vaping goods in Australia. The ban would include a broad range of media platforms, extending to social media and other forms of advertising, promotion and sponsorship. It is important that the public's exposure to advertising and promotion of vaping goods, which pose a serious risk to population health, is limited to combat the sale and uptake of vapes.

Proportionate: measure does not impinge on freedom of expression to a greater degree than is necessary

The restrictions are central to achieving the aims and objectives of the advertising measure and are proportionate to the public health risk posed.

Vaping goods are widely marketed, available and accessible to youth and young adults in Australia. Evidence suggests that exposure to these advertisements increases the likelihood that youth and young adults will try vaping. Direct exposure to vaping promotions has contributed to decreased risk perceptions for vaping. Some marketing of vaping goods is also emulating successful tobacco advertising, presenting vaping as an enviable lifestyle choice, aligning the products with celebrities and influencers, and fashionable and youthful places and activities.

Marketing of vaping goods intentionally targets youth and young adults through its promotional activities and product features. Vapes are aggressively promoted via online advertising and other youth-focused media channels. Advertising spending is often focused on social media promotion, allowing for lower costs and wider reach, particularly to youth and young adults. The marketing messages promote perceptions among youth and young adults that vaping goods are fun, cool, healthier and safer than tobacco cigarettes, and often focus on the appeal of flavours.

Despite the general prohibition, advertising would still be allowed to persons involved in the legitimate supply of therapeutic vapes (such as health professionals and pharmaceutical wholesalers) and where advice is given directly to a patient by a health practitioner in the course of treatment. The Secretary is also conferred with a power to permit advertising in specified circumstances.

It is also important to note that the term advertise has a limited meaning and does not cover all communications in relation to vapes. The term advertise is defined in section 3 of the Act. In effect it provides that to advertise goods means to intend, either directly or indirectly, to promote the use or supply of those goods.

Necessary: no less restrictive means of achieving the desired ends

The prohibition on advertising will contribute to efforts to reduce vaping rates in Australia. Given the widespread impact of advertising vaping goods, particularly in relation to unlawful vaping goods with no therapeutic purpose, restrictions are necessary to arrest the uptake of illegitimate vapes and to protect public health.

Vaping is associated with a range of short-term health risks and the long-term health risk are unknown. Further, there is evidence that vaping is a strong predictor of future tobacco use, particularly among youth and young adults. There is strong and consistent evidence that youths and young adults who vape are up to three times as likely to take up smoking, compared to those who do not. Smoking is the leading cause of preventable disease and death in Australia. Smoking reduces a person's life expectancy and their quality of life and may increase the risk of many conditions and diseases such as lung cancer, chronic obstructive pulmonary disease, heart disease, stroke and cardiovascular disease. Smoking can also cause diabetes, dental problems, hearing and vision loss and fertility problems.

The Bill, however, allows the promotion of therapeutic vaping goods in limited circumstances. A general prohibition on the advertising of vaping goods, with limited, and necessary exceptions, is the only means by to effectively combat the danger that such advertising poses to the Australian community.

Although the advertising measures applying to prohibition of advertising of vaping goods affects and limits, the freedom of expression, they are necessary to achieve the desired public health purpose and are proportionate to the need on which the limitation is predicated.

The right to a fair hearing

The Bill engages the right to a fair hearing under Article 14(1) of the ICCPR. The right to a fair hearing is a fundamental part of the rule of law and the proper administration of justice. The essential right guarantees equality before courts and tribunals, and, in the determination of criminal charges, or any suit at law, the right to a fair and public hearing before a competent, independent and impartial court or tribunals established by law. Those charged with a criminal offence have the rights set out in Articles 14(2) to (7), including the presumption of innocence and the guarantees set out in Article 14(2). The Bill engages this right and at the same time ensures that a defendant is provided with a right to a fair hearing before the relevant court, whether under an offence provision or a civil penalty provision. No provision relating to any of these offences seeks to displace or modify defendants' fair hearing rights under Article 14.

Application of both criminal and civil penalties

The Bill's offence provisions contain both criminal penalties and civil penalties. These include fault-based offences, strict liability offences and civil penalties. The Commonwealth will decide in each case whether to prosecute a person for a fault-based or strict liability offence, or whether to bring proceedings for a civil penalty order. Division 2 of Part 5A-1 of Chapter 5A of the TG Act places restrictions on what kinds of proceedings can be brought against persons who are alleged to have contravened the TG Act. These limitations broadly mirror those seen in Division 3 of Part 4 of the Regulatory Powers (Standard Provisions) Act 2014. The provision in the TG Act relating to bringing criminal proceedings after civil penalty orders have been issued against a person is more restrictive than the provision that regulates the same situation in the Regulatory Powers (Standard Provisions) Act 2014. The limitations imposed by Division 2 of Part 5A-1 of Chapter 5A of the TG Act will apply to all new offences and civil penalty provisions introduced by the Bill.

Most relevantly:

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section 42YF provides that the Federal Court must not make a pecuniary penalty order against a person for a contravention of a civil penalty provision if the person has been convicted of an offence constituted by conduct that is substantially the same as the conduct constituting the contravention;

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section 42YG operates to stay civil proceedings if criminal proceedings commence or have commenced and relate to the same, or substantially the same, conduct. This is to prevent any information that arises during criminal proceedings prejudicing civil proceedings. If the criminal proceedings result in a conviction, civil proceedings related to the same, or substantially the same, conduct will be dismissed. Civil proceedings may resume if the person is not convicted of the offence;

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section 42YH prevents criminal proceedings being brought against a person for conduct that is substantially the same as conduct constituting a contravention of a civil penalty provision if a pecuniary penalty order has been made against the person in respect of that conduct; and

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section 42YI provides that evidence given by an individual during proceedings for a civil penalty order cannot be used in any criminal proceedings, against the same individual relating to the same conduct. This ensures that information or documents produced during civil proceedings are not relied upon to support subsequent criminal proceedings, unless they are criminal proceedings relating to falsifying evidence in civil proceedings. While it is appropriate to allow criminal proceedings after civil proceedings have ended, given the overriding importance of the criminal justice system, criminal proceedings not related to falsifying evidence must rely upon evidence gathered during independent investigations, not evidence from prior civil proceedings.

Civil penalties

The Bill introduces, alongside criminal sanctions, civil penalty provisions relating to the importation, domestic manufacture, supply, commercial possession and advertisement of vaping goods. A civil penalty is a punitive sanction of a financial nature and provisions imposing civil penalties do not specify aggravating elements and fault elements. The penalties are imposed through civil court proceedings rather than through the criminal prosecution process. A civil penalty takes the form of a monetary penalty only and does not result in any criminal conviction. A criminal prosecution is a more appropriate sanction where a contravention is deliberate, where fraud may be involved, where the conduct demonstrates recklessness, where there is a serious pattern of continuous intentional contraventions, or where conduct has endangered lives or has caused death or serious injury.

A civil penalty is more appropriate to enable responsible persons to be fined for breaches of the TG Act where other sanctions, such as criminal prosecution, may not be as effective or appropriate in the circumstances. The civil penalty regime is also intended to act as a deterrent to behavior that breaches regulatory requirements, and also to act as an incentive for persons to establish systems designed to avoid breaches of regulatory requirements. In these ways, the civil penalty scheme is intended to prevent instances where public health and safety is, or could be, placed in jeopardy.

The focus of a civil penalty scheme is generally on the regulation of commercial activity. The inclusion of a civil penalty regime is proposed to strengthen enforcement options to deter non-compliance with regulatory requirements by persons whose main objective is monetary profit.

The levels of these penalties have been set having regard not just in relation to the significant impact on the health of the users of vaping goods but to the fact that the perpetrators stand to make significant financial gains from unlawful dealings with vaping goods. The potential monetary benefit of unlawful dealings with vaping goods is significant. The objective is, for the benefit of good health outcomes for consumers, to incentivise those who have the most to gain by breaching the TG Act to comply with regulatory requirements.

Prescribing conduct that is subject to a civil penalty could engage criminal process rights if the imposition of civil penalties is classified as 'criminal' under international human rights law.

Guidance Note 2: Offence provisions, civil penalties and human rights (December 2014), which is published by the Parliamentary Joint Committee on Human Rights, states that civil penalty provisions may engage criminal process rights under Articles 14 and 15 of the ICCPR, regardless of the distinction between criminal and civil penalties in domestic law.

When a provision imposes a civil penalty, an assessment is required as to whether it amounts to a 'criminal' penalty for the purposes of the ICCPR. Determining whether penalties could be criminal under international human rights law requires consideration of the classification of the penalty provisions under Australian domestic law, the nature and purpose of the penalties, and the severity of the penalties.

The Bill seeks to create various civil penalty provisions, which will be expressly classified as civil penalties for the purposes of Australian domestic law and will not impose criminal liability. For several reasons, the civil penalty provisions are unlikely to be considered criminal for the purposes of human rights. These provisions are not classified and identified as criminal under the TG Act. Rather, they are alternatives to criminal prosecution and do not carry a sanction for imprisonment for non-payment. Further, a finding of breach will not lead to the creation of a criminal record. The provisions are part of an enforcement regime to incentivise those who would otherwise have much to gain by not complying with regulatory requirements to comply for the benefit of public health thus the high level of penalty. As such, the criminal process rights under Articles 14 and 15 of the ICCPR would be unlikely to apply.

The civil penalty provisions in the Bill are principally intended to provide an effective deterrent to non-compliance, and to reflect the serious potential impact on public health of non-compliance. Prosecution of a person for contravention of a civil penalty provision will generally only be considered after other available compliance measures have been considered. Those measures may include, for example, the giving of an infringement notice.

To provide effective deterrence, the penalties for individuals and bodies corporate are significant ranging from a maximum 5,000 penalty units for individuals to 50,000 penalty units for bodies corporate, to 7,000 penalty units for individuals to 70,000 penalty units for bodies corporate. These high penalties are commensurate to the public health risks associated with the use of vaping goods. The civil penalty contraventions are not directed to members of the public in general but only to those who are importing, manufacturing, supplying, commercially possessing and advertising illegal vaping goods. These penalties are comparable with existing civil penalty provisions under the TG Act and consistent with the penalties for similar conduct in comparable legislation, such as the Corporations Act 2001 (section 1317G) and pecuniary penalties under consumer law under Competition and Consumer Act 2010.

Thus, the civil penalties are classified as civil penalties and not criminal for the purposes of human rights law.

Further, a person who is the subject of a civil penalty proceeding has a right to a fair hearing before a competent, independent, and impartial court as provided for under the current Part 5A-1 (civil penalties) under Chapter 5A of the TG Act, which supports compatibility with the right to a fair hearing under Article 14(1) of the ICCPR.

The right to the presumption of innocence under Article 14(2)

Article 14(2) of the ICCPR provides that everyone charged with a criminal offence shall have the right to be presumed innocent until proven guilty according to law. The right to presumption of innocence is also a fundamental common law principle.

Strict liability offences

When strict liability applies to an offence, the prosecution is only required to prove the physical elements of an offence, not the fault elements, beyond reasonable doubt for the defendant to be found guilty. The defence of honest and reasonable mistake of fact is available to the defendant (see section 9.2 of the Criminal Code).

Strict liability is used in circumstances where there is a public interest in ensuring that regulatory schemes are observed, and it can be reasonably expected that the person was aware of their duties and obligations. Strict liability offences can be considered a limitation of the presumption of innocence because the defendant can be found guilty without the prosecution being required to prove fault.

The inclusion of strict liability offences for a contravention of the TG Act is a purposeful deterrence measure. A requirement for the prosecution to prove the existence of a fault element, such as intention or recklessness, would not adequately protect the public from the supply, and advertising for supply, of vapes, that are non-compliant with requisite regulatory obligations.

Strict liability offences are introduced because of the potential risk to public health arising from vapes, to strike an appropriate balance between deterrence and the right of the individual to be presumed innocent. The conduct involved in these offences is sufficiently serious that, if the defendant were convicted of an equivalent fault-based offence, a much higher penalty could be imposed including, in some cases, a significant term of imprisonment.

The strict liability provisions are compatible with Article 14(2) of the ICCPR, as the provisions pursue a legitimate objective in acting as a deterrent to behaviour that may otherwise represent a risk to public health, in particular, youth and young people, and are reasonable and proportionate in achieving that outcome. Where the prosecution that the defendant is culpable and the relevant fault elements such as intention and recklessness can be established, the normal fault-based offence could be pursued.

Reverse burden of proof

The primary offences in the Bill have offence and civil penalty specific defences, described in the Bill as exceptions. In effect, these defences reverse the burden of proof that would usually apply in an offence or civil penalty contravention, by requiring the defendant to discharge the evidential burden of proof for one or more elements. The reverse onus represents a departure from the ordinary principle of criminal law that a defendant is presumed to be innocent, and that the prosecution must prove every element of an offence relevant to the person's guilt.

The exceptions for relevant offences and civil penalty contraventions are set out in subsection 41Q(5) for importation, subsection 41QA(5) for manufacture, subsections 41QB(6), (7) and (8) operating in conjunction for wholesale supply, subsections 41QB(9), (10) and (11) operating in conjunction for retail supply, subsections 41QC(13) and (14) operating in conjunction for possession of a commercial quantity and subsections 41QD (7) and (8) operating in conjunction for possession of less than a commercial quantity. Under these exceptions, a person charged with the relevant offence will bear the evidential burden – that is, the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist (see subsection 13.3 of the Criminal Code). In each case, placing the evidential burden on the defendant is a reasonable and proportionate measure to ensure the effective regulation of vaping goods.

Although counter to the fundamental principle of the presumption of innocence, it is established practice that reversal of burden offences are reasonable and appropriate in circumstances in which relevant matters will ordinarily and peculiarly be within the defendant's knowledge while also be easily adduced by the defendant and where the conduct proscribed by the offence poses a grave danger to public health or safety. The existence of evidence relating to a particular licence, authorisation, approval, permission or exemption in relation to certain vaping goods or conduct is particularly within the knowledge of the defendant.

This approach is well established in Commonwealth and state and territory legislation. The presence of exceptions, for which the defendant must adduce or point to evidence that is peculiarly within their knowledge, can be seen in offence provisions under the TG Act (sections 19B and 41MI), the Criminal Code (sections 137.1 and 137.2), and state legislation such as the Drug Misuse and Trafficking Act 1985 NSW (section 10).

The Bill introduces offences and civil penalty provisions that prohibit the import, manufacture, advertising, supply and commercial possession of vaping goods, subject to exceptions. Depending on the prohibited conduct, the exceptions include where the person has the appropriate licence, authority, approval or authorisation, the person was granted a consent by the Secretary of the Department to carry out those activities or the goods are supplied within the existing (lawful) pharmaceutical supply chain. The prohibited conduct and supply chain are made up of controls at the Commonwealth or state and territory levels, or both. The enforcement of these prohibitions is to be undertaken by both states and territories, as well as the Commonwealth. For this reason, the evidence to substantiate the lawful status of the goods, or the specified activity will not rest with one government agency and is very likely to be split across many.

In contrast, the person seeking to rely on the exceptions will likely hold the evidence to substantiate the lawful status of the goods with respect to relevant importation, manufacture, supply or possession activities. The burden on the defendant is evidential only, meaning that the defendant must adduce or point to evidence that suggests a reasonable possibility that the matter exists or does not exist. If that burden is discharged, the prosecution must disprove the matters in the exception beyond reasonable doubt, or in civil penalty proceedings on the balance of probabilities.

Reversing the burden of proof is justified because of the public interest in the efficient regulation of vaping goods, noting the seriousness of the public health harms associated with vaping in Australia. The Bill provides a list of the necessary evidence that a defendant needs to produce, such as an authority to prescribe a prescription only medicine in a state or territory or otherwise deal with vaping goods.

Thus, these provisions, despite reversing the evidential burden, are compatible with Article 14(2) of the ICCPR, as they pursue a legitimate objective in acting as a deterrent to behaviour and activities that may otherwise represent a risk to public health, and are reasonable and proportionate in achieving that outcome.

The right to be free from self-incrimination

Article 14(3)(g) of the ICCPR protects the right of an individual to be free from self-incrimination in the determination of a criminal charge by providing that a person cannot be compelled to testify against him or herself or confess guilt. The common law also recognises the privilege against self-incrimination, which applies unless expressly or impliedly overridden by statute. The privilege against self-incrimination may be subject to permissible limits but any such limitations must be for a legitimate objective and be reasonable, necessary and proportionate to that objective.

This Bill limits the right for an individual to be free from self-incrimination where the exercise of this right could seriously undermine the effectiveness of the regulatory scheme and prevent the identification of persons involved in the advertising, and potentially the supply, of vaping goods.

Sections 42DZD and 42DZE provide an offence and civil penalty where a person advertises or causes the advertising of vaping goods without authorisation or in a manner that does not comply with an authorisation that has been given. However, it may not be clear from the outset whether the person responsible for the advertisement was the person apparently responsible or a third party. Sections 42DZF, 42DZG, and 42DZH confer a power to require production, by a person apparently responsible for advertising vaping goods, of specified information relating to advertisements about vaping goods, which could be used to obtain information about the procurement of an advertisement, such as the identity of the procurer.

Without limiting the right to be free from self-incrimination, persons apparently responsible for advertising could withhold pertinent information that would seriously undermine the Secretary's power to identify persons involved in the advertising, and potentially the supply, of vaping goods.

Section 42DZJ therefore removes the privilege against self-incrimination in relation to the requirement to provide specified information under sections 42DZF.

The abrogation of the privilege is acceptable in the circumstances because the specified information will generally only be within the knowledge of the person concerned and persons who may be acting unlawfully and would be unlikely to identify themselves. Further, the abrogation of the privilege is accompanied by immunity under subsection 42DZJ(2) from further criminal or civil proceedings against the individual to whom a requirement to produce specified information is directed, other than in a limited number of proceedings. These proceedings are those in relation to an offence for providing information or document in response to a notice and the information of document is false or misleading in a material particular (subsections 42DZG(3) and (4) refer), or a civil penalty contravention proceeding under subsection 42DZH where the person complying with the notice gives information or documents that are false or misleading in a material particular. The proceedings would be justifiable to ensure that the person complying with the notice provides relevant information or documents that are not false or misleading in a material particular.

Criminal offences and civil penalty provisions relating to the importation, manufacture, supply, commercial possession and advertisement of vaping goods, subject to exceptions

The Bill introduces the following offences and civil penalty contraventions, subject to exceptions:

(a)

section 41Q provides a fault-based offence (subsection 41Q(1) refers), an offence of strict liability (subsection 41Q(2) refers), and a civil penalty provision (subsection 41Q(3) refers) relating to the importation of vaping goods in Australia. Subsections 41Q(1), (2) and (3) do not apply if the importation of the vaping goods would not be prohibited under the CPI Regulations under the Customs Act 1901 (the Customs Act);

(b)

section 41QA provides a fault-based offence, a strict liability offence and a civil penalty provision relating to the manufacture of vaping goods at premises in Australia. These offences and civil penalty contravention do not apply if the vaping goods are therapeutic goods and the person manufacturing the goods:

(i)

is a holder of a manufacturing licence under Part 3-3 of the TG Act, or

(ii)

holds a conformity assessment document that applies to the vaping goods; or

(iii)

was granted a consent under subsection 41RC(1) to manufacture the vaping goods, or carry out the manufacture of the vaping goods at the premises and the manufacture, or the step was carried out in accordance with the consent;

(c)

section 41QB provides a fault-based offence, a strict liability offence and a civil penalty provision relating to the supply of vaping goods. Exceptions from the application of these provisions apply in relation to legitimate persons involved in the wholesale supply chain and the retail supply chain of therapeutic vapes respectively;

(d)

section 41QC provides fault-based offences, strict liability offences and civil penalty provisions relating to the possession of at least commercial quantities of vaping goods. Exceptions to the application of these provisions apply in relation to legitimate persons involved in the supply chain for therapeutic vapes Absolute liability applies to the physical element of the fault-based offence in relation to the specified quantity of the kind of vaping goods;

(e)

section 41QD provides a fault-based offence, a strict liability offence and a civil penalty provision relating to the possession of less than a commercial quantity of vaping goods, subject to exceptions. Absolute liability applies to the physical element of the fault-based offence in relation to the quantity being less than a commercial quantity of that kind of vaping goods. Exceptions to the application of these provisions apply in relation to legitimate persons involved in the supply chain for therapeutic vapes. Importantly, there is also an exception if possession is for personal use or if a person possesses vaping goods on behalf of another person for whom the goods have been lawfully supplied;

(f)

section 42DZD provides a fault-based offence and a strict liability offence relating to the advertisement of vaping goods, which is not authorised, or if authorised does not comply with the authorisation;

(g)

section 42DZE provides a civil penalty provision relating to the advertisement of vaping goods, which are not authorised or if authorised does not comply with the authorisation;

(h)

section 42DZG provides fault-based offences and strict liability offences for the failure to comply with a notice under section 42DZF or provision of false or misleading information;

(i)

section 42DZH provides a civil penalty provision in relation to giving false or misleading information or document in compliance with a notice under section 42DZF;

(j)

section 42DZL provides offences for contravening a direction under section 42DZK; and

(k)

section 42DZM provides civil penalty provisions for contravening a direction under section 42DZK.

The right not to be tried or punished again for an offence for which a person has already been finally convicted or acquitted

Article 14(7) of the ICCPR provides that "no one shall be liable to be tried or punished again for an offence for which he has already been finally convicted or acquitted in accordance with the law and penal procedure of each country". This prohibition on double jeopardy is also a fundamental safeguard in the common law of Australia. It means that a person who has been convicted or acquitted of a criminal charge is not to be re-tried for the same or substantially the same offence. This prohibition, as provided in Article 14(7), is limited to proceedings relating to a criminal charge. However, it is noted that whether a proceeding is civil or relates to a criminal charge under Article 14(7) is determined by the substance and the effect of the proceedings themselves, rather than their label under domestic law.

The right not to be twice tried or punished for the same offence may be engaged as the Bill permits both criminal and 'civil' proceedings to be brought against a person for the same conduct. However, the commencement and conduct of proceedings brought under the offences and civil penalty provisions introduced by the Bill are subject to the requirements under Division 2 of Part 5A-1 of Chapter 5A of the TG Act. Under Division 2 of Part 5A-1 criminal proceedings may not be commenced against a person after they have been ordered to pay a civil penalty for the same conduct. Similarly, criminal proceedings cannot be brought against a person for conduct that has already been the subject of civil penalty order. Finally, any civil proceedings for the same conduct for which criminal proceedings have commenced are stayed and can only be re-instated if the person is not convicted of the criminal offence.

Absolute liability

The Bill includes absolute liability fault element to specified physical elements set out in paragraphs 41QC(1)(b), 41QC(4)(b), 41QC(7)(b) and 41QD(1)(b) of the fault-based offences.

In relation to paragraph 41QC(1)(b), for example, the absolute liability fault element is proposed because it would be quite challenging and difficult to prove beyond reasonable doubt that a person was reckless that the quantity in their possession was at least a commercial quantity but less than 100 times the commercial quantity.

Similarly, it would be quite challenging for the prosecution to prove beyond reasonable doubt that a person was reckless that the quantity in their possession was at least a commercial quantity but less than 100 times the commercial quantity. Although recklessness is a lower threshold than knowledge or intention, the prosecution would still be required to point to some evidence that suggests the defendant was reckless as to the specific quantity. This includes recklessness as to what a commercial quantity is under the Regulations.

Requiring proof of fault of the relevant element to which strict or absolute liability applies would undermine deterrence in relation to the possession of a commercial quantity of vaping goods, and there are legitimate grounds for penalising persons lacking the necessary fault in respect of that element. The objective is to deter the possession and subsequent supply of commercial quantities of vaping goods in Australia. At the same time, supply and possession of vaping goods for smoking cessation or the management of nicotine dependence would be permissible. The circumstances where possession of these goods are allowed or acceptable are set out in the exceptions to the offences.

The same reasoning applies to new paragraphs 41QC(4)(b), 41QC(7)(b), and 41QD(1)(b). By way of comparison, for drug offences under the Criminal Code, the fault element attached to the physical element relating to quantity (which is circumstance) is absolute liability (see s 6.2 of the Code). As such, there are no fault elements attributed to the physical element that the drugs are of a certain quantity.

An example of this approach can be found in s 307.5 of the Code:

"307.5 Possessing commercial quantities of unlawfully imported border controlled drugs or border controlled plants

(1)

A person commits an offence if:

(a)

the person possesses a substance; and

(b)

the substance was unlawfully imported; and

(c)

the substance is a border controlled drug or border controlled plant; and

(d)

the quantity possessed is a commercial quantity.

Penalty: Imprisonment for life or 7,500 penalty units, or both.

(2)

Absolute liability applies to paragraphs (1)(b) and (d).

(3)

The fault element for paragraph (1)(c) is recklessness.

(4)

Subsection (1) does not apply if the person proves that he or she did not know that the border controlled drug or border controlled plant was unlawfully imported.

Note: A defendant bears a legal burden in relation to the matter in subsection (4) (see section 13.4)."

The rationale behind this approach is discussed in the Explanatory Memorandum to the Law and Justice Legislation Amendment (Serious Drug Offences and Other Measures) Bill 2005:

"Applying absolute liability to the element of quantity...will markedly improve the enforceability of these offences [drug offences]. This approach was recommended by MCCOC in 2003 as a modification to the model offences originally proposed in its 1998 report and was also endorsed by the Standing Committee of Attorneys-General".

The MCCOC refers to the Model Criminal Code Officers Committee of the Standing Committee of Attorneys-General, which was involved in the development of a national model criminal code for Australian jurisdictions.

Applying this approach to new draft 41QC(1), provided the prosecution can establish that the quantity is at least a commercial quantity but less than 100 times the commercial quantity, both the physical and fault elements will be satisfied. The same observations can be made for the other possession offences in the Bill. Note, however, that despite the inclusion of the absolute liability fault element, the human rights relating to presumption of innocence, the right to a fair trial and hearing, and the right not to be tried or punished again for an offence for which a person has already been finally convicted or acquitted all apply to the defendant.

The human rights identified in Article 14 of the ICCPR, are engaged by the Bill but the Bill does not limit those rights, and if it does there are legitimate reasons for doing so to ensure that access to vaping goods is appropriately restricted. In achieving that objective, any limitation to a particular human right is proportionate to that objective.

Conclusion

The Bill is compatible with human rights because it promotes and supports a number of rights and to the extent that it limits other rights, the limitations are reasonable, necessary and proportionate.

The Bill promotes and supports the following rights:

•

the right to health under Article 12 of the ICESCR;

•

the right to life under Article 6 of the International Covenant on Civil and Political Rights (ICCPR);

•

the obligation to ensure the survival and development of children under Article 6(2) of the Convention of the Rights of the Child (CRC);

•

the obligation to protect children from illicit use of narcotic drugs and psychotropic substances under Article 33 of the CRC.

The Bill engages a number of other rights, being:

•

the right to privacy under Article 17 of the 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;

•

the right to the presumption of innocence under Article 14(2) of the ICCPR;

•

the right to be free from self-incrimination under Article 14(3)(g) of the ICCPR;

•

the right not to be tried or punished again for an offence for which a person has already been finally convicted or acquitted under Article 14(7) of the ICCPR.

However, to the extent that the Bill limits any of these rights the limitations are reasonable, necessary and proportionate to achieving the aim of protecting public health by limiting access to harmful vaping goods.