Therapeutic Goods (Information Specification—Therapeutic Vaping Goods and Vaping Devices) Instrument 2023

EXPLANATORY STATEMENT

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 (“the Act”) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy or performance, and timely availability of therapeutic goods that are used in, or exported from, Australia. The Act is administered by the Therapeutic Goods Administration (“the TGA”) within the Australian Government Department of Health and Aged Care (“the Department”).

Section 61 of the Act provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies, or authorities. Subsection 61(1) of the Act defines ‘therapeutic goods information’, for the purpose of section 61, as information relating to therapeutic goods which is held by the Department and relates to the performance of the Department’s functions.

Under subsection 61(5AA) of the Act, the Secretary may release specified therapeutic goods information, for a specified purpose, to a person, body or authority that is, or is of a kind, specified under subsection 61(5AB) of the Act. Under subsection 61(5C) of the Act, the Secretary may release to the public kinds of therapeutic goods information specified under subsection 61(5D) of the Act.

The Therapeutic Goods (Information Specification—Therapeutic Vaping Goods and Vaping Devices) Instrument 2023 (“the Instrument”) is a legislative instrument made under subsections 61(5AB) and (5D) of the Act.

The Instrument specifies, for the purposes of subsection 61(5AA) of the Act, the kinds of therapeutic goods information that the Secretary may release to specified persons, bodies or authorities, and the purpose for which that information may be released. The persons, bodies and authorities specified in the Instrument are Commonwealth, state or territory authorities with functions relating to therapeutic goods, health or law enforcement, and the Australian Taxation Office (“ATO”). The Instrument authorises the release of specified therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, components or articles used in the manufacture of therapeutic vaping goods, disposable therapeutic vapes and therapeutic cannabis vaping goods. The Instrument authorises release to those persons, bodies and authorities for the purpose of for the purpose of supporting compliance and enforcement activities relating to the importation, manufacture and supply of therapeutic vaping goods and the other goods to which the Instrument applies.

The Instrument also specifies, for the purposes of subsection 61(5C) of the Act, the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5D) of the Act. The Instrument authorises the release of therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, and components or articles used in the manufacture of therapeutic vaping goods, that are the subject of a notice (by the sponsor that the goods comply with an applicable standard, or the essential principles) or determination (by the Secretary that the goods do not comply) under the Therapeutic Goods Regulations 1990 (“the TG Regulations”) or the Therapeutic Goods (Medical Devices) Regulations 2002 (“the MD Regulations”).

Background

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 vapes in Australia.

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 or tobacco smoking. These changes were intended to prevent youth and young adults from taking up vapes, while allowing current smokers access 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 are therefore needed to curb the increase in the rates of vaping, and to control the availability of vaping products that are being accessed by youth and young adults.

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.

Reforms to the regulation of vapes

The Australian Government is implementing reforms to the regulation of vapes to address the growing public health problem associated with vaping. The reforms are proposed to prohibit the importation, manufacture and supply of disposable single use and non-therapeutic vapes, while strengthening the regulatory controls of therapeutic vapes. This will be achieved through amendments to the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002, the Customs Act 1901 and the Customs (Prohibited Imports) Regulations 1956, as well as new and amended delegated instruments under the Act. A transitional approach will apply to the commencement of the reforms to allow a reasonable time for importers, manufacturers and suppliers to comply with the enhanced regulation, while maintaining legitimate patient access to therapeutic vaping goods for smoking cessation or the management of nicotine dependence.

The reforms are intended to address the risks posed by vaping to youth and young adults in Australia, the possible long term adverse health effects of vaping to Australians who use vapes, and the adverse health effects of toxic chemicals and other ingredients found in vapes. At the same time, the proposed amendment would preserve patient access to therapeutic vapes under the supervision of relevant health practitioners.

In broad terms, the first stage of the reforms will:

prohibit the importation of disposable single use vapes, irrespective of therapeutic claims, subject to limited exceptions, from 1 January 2024;
prohibit the importation of non-therapeutic vapes, irrespective of nicotine content, subject to limited exceptions, from 1 March 2024;
introduce the requirement for importers to obtain a customs licence and permit to import therapeutic vapes, subject to limited exceptions, from 1 March 2024, with applications to be enabled from 1 January 2024;
end the personal importation scheme for therapeutic vapes – the scheme will cease to operate on 1 March 2024, but the importation of disposable vapes will be prohibited from 1 January 2024;
retain a limited traveller’s exception that allows persons arriving in Australia by ship or plane to carry a limited quantity of vapes for their treatment or the treatment of someone travelling with them under their care – revisions to the traveller’s exemption will commence on 1 March 2024 with restrictions on disposable vapes commencing 1 January 2024;
introduce the requirement for importers and manufacturers to notify the Secretary that therapeutic vapes intended to be imported, or released for supply in Australia, comply with relevant product standards or essential principles, as the case may be – this requirement will commence on 1 March 2024, with notifications to be enabled from 1 January 2024;
modify the exemptions relating to unregistered therapeutic vapes to require such goods to be supplied through prescription medicine supply chains to patients for smoking cessation or the management of nicotine dependence – this requirement will commence on 1 March 2024;
make minor changes to relevant product standards to facilitate the introduction of the notification and permit schemes, introduce restrictions on flavours and ensure minimum standards for device components; and

enable therapeutic vapes to be accessed by patients under the Special Access Scheme – Category C, to facilitate more timely access to unregistered therapeutic vapes and reduce regulatory burden on practitioners, while maintaining regulatory oversight commensurate with the risk.

These changes will be supplemented with amendments to the Act that are proposed to be introduced to Parliament next year. The amendments will strengthen domestic compliance and enforcement mechanisms to support the broader policy intent. Compliance and enforcement effort both within and between jurisdictions is essential to address the risk of vaping to population health.

The new framework will support the following public health objectives to:

arrest the uptake of vapes, other than for therapeutic purposes, especially in youth and young adults aged below 25 years;
counteract the marketing of vapes to youth and young adults, especially through product features such as flavours and packaging;
reduce nicotine dependence and the risk of future tobacco use; and
safeguard public health by requiring unregistered therapeutic vapes to meet minimum quality and safety standards.

Importantly, the reforms will promote 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.

Purpose

The Instrument is made under subsections 61(5AB) and (5D) of the Act. The Instrument specifies, for the purposes of subsection 61(5AA) of the Act, the kinds of therapeutic goods information that the Secretary may release to specified persons, bodies or authorities, and the purpose for which that information may be released to those persons, bodies or authorities. The Instrument also specifies, for the purposes of subsection 61(5C) of the Act, the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5D) of the Act.

Subsection 5(1) and Schedule 1 to the Instrument provide for the release of specified therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, components or articles used in the manufacture of vaping goods, disposable therapeutic vapes and therapeutic cannabis vaping goods. It provides for the release of this information to persons, bodies and authorities including Commonwealth, state or territory authorities with functions relating to therapeutic goods, health or law enforcement, and the ATO, for the purpose of supporting compliance and enforcement activities relating to the importation, manufacture and supply of therapeutic vaping goods and other goods to which the Instrument applies. Release of information to these bodies or authorities is necessary to give effect to the Government’s proposed reforms addressing the growing public health problem associated with vaping. Each body or authority plays a pivotal role in the enforcement of the proposed reforms. For example, the Australian Border Force will be responsible for seizing unlawful therapeutic vaping goods at the border. The ATO will be responsible for investigating money laundering that may be associated with the supply of unlawful therapeutic vaping goods, and otherwise enforcing tobacco excises that be may applicable to goods to which the Instrument applies.

More specifically, the kinds of therapeutic goods information that may be released to Commonwealth authorities, state or territory authorities, and the ATO includes the following:

details about the goods, including formulation, composition, design specification or presentation,
information about the importation, manufacture or supply of the goods;
information about the sponsor of the goods;
information about other persons involved, or apparently involved, in the importation, manufacture or supply of the goods
a notice, or information about a notice, or the absence of a notice, that relates to the goods under item 15 in Schedule 5A to the TG Regulations or 2.17 in Part 2 of Schedule 4 to the MD Regulations;
a determination, or information about a determination, by the Secretary under item 15 in Schedule 5A to the TG Regulations or item 2.17 in Part 2 of Schedule 4 to the MD Regulations that relates to the goods;
information about a compliance or enforcement activity conducted, or proposed to be conducted, in relation to the goods, including but not limited to search, seizure, destruction, recall, the giving of an infringement notice, or the commencement of a civil penalty proceeding or criminal prosecution;
information or evidence provided by the sponsor to support statements made in a notice under item 15 of Schedule 5A to the TG Regulations or item 2.17 of Part 2 of Schedule 4 to the MD Regulations;
complaints, intelligence or any other information about the compliance of the goods with requirements under the Act, including but not limited to the conditions of an applicable exemption;
complaints, intelligence or any other information about the compliance of persons involved, or apparently involved, in the importation, manufacture or supply of the goods;
information about compliance with an applicable standard or the essential principles (as relevant);
a consent, or information about a consent, or the absence of a consent, that relates to the goods under sections 14, 14A, 41MA or 41MAA of the Act;
an approval, or information about an approval, or the absence of an approval, that relates to the goods under sections 19, 41HB or 41HC of the Act;
a permit, or information about a permit, or the absence of a permit, issued under regulation 5 or 5A of the Customs (Prohibited Imports) Regulations 1956 (“the Customs Regulations”) that relates to the goods;
information relating to an investigation or finding about compliance of the goods with regulations 5 or 5A of the Customs Regulations;
information relating to the examination or testing, and the results of the examination or testing, of a sample of the goods.

The Instrument also authorises the release of certain therapeutic goods information to the public. The information that may be released is therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, and components or articles used in the manufacture of vaping goods, that are the subject of a notice (that the goods comply with applicable standards or the essential principles) or should have been the subject of such a notice. The Instrument also authorises the release of information to the public relating to a determination by the Secretary that the goods do not comply the applicable standards, or essential principles, or compromises public health and safety.

The kinds of therapeutic goods information that may be released to the public would include, for example:

details of the goods, including strength and presentation;
details of the sponsor of the goods;
the date notice of compliance with relevant standards was given by the sponsor to the Secretary;
information relating to the compliance of the goods with the applicable standards, essential principles, or any consent given in relation to the goods under section 14, 14A, 41MA or 41MAA of the Act;
other information relating to compliance of the goods with the conditions of the exemption under which the notice was given;
for those goods that are the subject of a determination under the relevant exemption item by the Secretary, information about the date of the determination, the reasons for the determination and actions, or possible actions, that may be reasonable and appropriate to take under the Act in the interests of public health and safety;
for those goods that are not the subject of a notice to the Secretary, information about the importation, manufacture and supply of the goods and actions, or possible actions, that may be reasonable and appropriate to take under the Act in the interests of public health and safety.

The publication of information relating to vaping goods that are the subject of a notice or determination, is critical to ensure that Australian patients and health practitioners prescribing vaping goods are able to easily identify vaping goods that meet minimum safety, quality, efficacy or performance requirements for such goods.

Consultation

The TGA conducted two significant consultations in relation to the vaping reform measures. Between 30 November 2022 and 16 January 2023, the TGA undertook public consultation (“the 2022 consultation”) on reforms to the regulation of nicotine vaping products in Australia. Close to 4,000 submissions were received from a range of organisations and individuals, including state and territory health departments, universities, health practitioner peak bodies, consumer groups, retailers, and suppliers. This included over 3,500 submissions from private individuals.

Following feedback from this consultation and advice received from public health experts at Tobacco Control Roundtables on 30 September 2022 and 17 April 2023, the TGA engaged in extensive consultation with the states and territories to assess the regulatory options and develop policy proposals. Consultations with the states and territories took place principally through the Health Ministers’ Meeting and its subordinate National E-Cigarette Working Group, culminating in the Health Ministers’ Meeting Communique of 1 September 2023, which conveyed Ministers’ collective commitment to enhancing regulation of vapes in Australia.

A second, targeted consultation was undertaken with stakeholders between 7 September and 21 September 2023 (“the 2023 Consultation”) on the regulatory proposals developed in consultation with states and territories. Submissions and survey responses to the 2023 Consultation closed on 21 September 2023. The feedback to the consultation paper informed the deliberations of the Minister for the Department of Health and Aged Care on regulatory measures to be implemented.

Other details

Details of the Instrument are set out in Attachment A.

The Instrument is compatible with human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.

An impact analysis (“IA”) was prepared on the proposed reforms relating to the regulation of vapes, taking into account the feedback received from stakeholders throughout the consultations. The Office of Impact Analysis (“OIA”) determined that the IA was consistent with good practice and met Australian Government best practice regulation requirements (OBPR23-03933). The IA has been published, or will be published, prior to commencement of the Instrument on the OIA website at: oia.pmc.gov.au/.

The Instrument is a disallowable legislative instrument for the purposes of the Legislation Act 2003 and commences at the same time as the commencement of the Therapeutic Goods Amendment (Vaping) Regulations 2023 (“the Amendment Regulations”). However, the Amendment Instrument does not commence at all if the Amendment Regulations do not commence.

Attachment A

Details of the Therapeutic Goods (Information Specification—Therapeutic Vaping Goods and Vaping Devices) Instrument 2023

Section 1 Name

This section provides that the name of the instrument is the Therapeutic Goods (Information Specification—Therapeutic Vaping Goods and Vaping Devices) Instrument 2023 (“the Instrument”).

Section 2 Commencement

This section provides that the Instrument commences at the same time as the commencement of the Therapeutic Goods Amendment (Vaping) Regulations 2023 (“the Amendment Regulations”). However, the Instrument does not commence at all if the Amendment Regulations do not commence.

Section 3 Authority

This section provides that the legislative authority for making the Instrument is subsections 61(5AB) and (5D) of the Therapeutic Goods Act 1989 (“the Act”).

Section 4 Definitions

This section provides the definitions of key terms used in the Instrument, including ‘Commonwealth authority’, ‘disposable therapeutic vape’, ‘sample’, ‘state or territory authority’, ‘therapeutic cannabis vaping good’, ‘therapeutic vaping device’, ‘therapeutic vaping goods’ and ‘therapeutic vaping pack’.

The definition of ‘therapeutic vaping device’ has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002 (“the MD Regulations”), and refers to a therapeutic good that is a vaping device (other than a disposable vape or a therapeutic cannabis vaping device). Relevantly, the Therapeutic Goods Regulations 1990 (“the TG Regulations”) define a ‘vaping device’ as a device that generates or releases (or is designed or intended to generate or release), using a heating element and by electronic means, an aerosol, vapour or mist for direct inhalation by its user.

This section also notes that a number of terms used in the Instrument have the meaning given in subsection 3(1) of the Act, including, ‘Commonwealth officer’, ‘presentation’, ‘Secretary’, ‘sponsor’ and ‘therapeutic goods’.

Subsections 4(2) and (3) provide, for the avoidance of doubt, the scope of the terms ‘test’ and ‘sample’ used in this Instrument.

Section 5 Release of therapeutic goods information

This section provides that, for the purpose of subsection 61(5AA) of the Act, the kinds of therapeutic goods information specified in column 2 of each item of the table in Schedule 1 may be released to a person, body or authority (or kinds of persons, bodies or authorities) specified in column 3, for the purposes specified in column 4.

This section also provides that, for the purpose of subsection 61(5C) of the Act, the kinds of therapeutic goods information specified in the table in Schedule 2 may be released to the public.

Schedule 1 – Release to a person, body or authority

For subsection 5(1) of the instrument, this Schedule specifies kinds of therapeutic goods information, the persons, bodies and authorities that may receive that information, and purposes for which the information may be released.

The persons, bodies or authorities specified in each item of the table in Schedule 1 are:

a Commonwealth authority;
a state or territory authority;
the Australian Taxation Office.

These persons, bodies or authorities all have functions relating to either therapeutic goods, health or law enforcement, as well as intelligence functions relevant to assessing to compliance with the therapeutic goods regulatory scheme.

The purposes specified in each item of the table in Schedule 1 are to support compliance and enforcement activities relating to the importation, manufacture and supply of the relevant vaping goods. The sharing of information under the Instrument is critical to enabling assessment of compliance with the therapeutic goods regulatory scheme and enforcement action to be taken to protect public health and safety.

The kinds of information specified in the items of the table in Schedule 1 includes information about therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, components or articles used in the manufacture of vaping goods, disposable therapeutic vapes and therapeutic cannabis vaping goods. That information includes, as relevant:

details about the goods, including formulation, composition, design specification or presentation;
information about the importation, manufacture or supply of the goods;
information about the sponsor of the goods;
information about other persons involved, or apparently involved, in the importation, manufacture or supply of the goods;
a notice, or information about a notice, or the absence of a notice, that relates to the goods under item 15 in Schedule 5A to the TG Regulations or 2.17 in Part 2 of Schedule 4 to the MD Regulations;
a determination, or information about a determination, by the Secretary under item 15 in Schedule 5A to the TG Regulations or item 2.17 in Part 2 of Schedule 4 to the MD Regulations that relates to the goods;
information about a compliance or enforcement activity conducted, or proposed to be conducted, in relation to the goods, including but not limited to search, seizure, destruction, recall, the giving of an infringement notice, or the commencement of a civil penalty proceeding or criminal prosecution;
information or evidence provided by the sponsor to support statements made in a notice under item 15 of Schedule 5A to the TG Regulations or item 2.17 of Part 2 of Schedule 4 to the MD Regulations;
complaints, intelligence or any other information about the compliance of the goods with requirements under the Act, including but not limited to the conditions of an applicable exemption;
complaints, intelligence or any other information about the compliance of persons involved, or apparently involved, in the importation, manufacture or supply of the goods;
information about compliance with an applicable standard or the essential principles (as relevant);
a consent, or information about a consent, or the absence of a consent, that relates to the goods under sections 14, 14A, 41MA or 41MAA of the Act;
an approval, or information about an approval, or the absence of an approval, that relates to the goods under sections 19, 41HB or 41HC of the Act;
a permit, or information about a permit, or the absence of a permit, issued under regulation 5 or 5A of the Customs (Prohibited Imports) Regulations 1956 (“the Customs Regulations”) that relates to the goods;
information relating to an investigation or finding about compliance of the goods with regulations 5 or 5A of the Customs Regulations;
information relating to the examination or testing, and the results of the examination or testing, of a sample of the goods.

Schedule 2 –Release to the public

This Schedule specifies, for the purpose of subsection 5(2) of the Instrument, the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act.

Items 1 and 2 of the table in Schedule 2 to the Instrument specify information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, and components or articles used in the manufacture of vaping goods, that are (as relevant) the subject of a notice (that the goods comply with applicable standards or the essential principles) under the relevant exemptions in the TG Regulations or the MD Regulations. This information includes information relating to the details of the goods, including strength and presentation which includes photographs of the goods, details of the sponsor of the goods, the date the notice was given by the sponsor to the Secretary, any information relating to the compliance of the goods with applicable standards, essential principles, or a consent given in relation to the goods, and other information relating to compliance with the conditions of the exemption under which the notice was given.

Item 3 of the table in Schedule 2 to the Instrument specifies information relating to therapeutic vaping goods, therapeutic vaping kits and goods in a therapeutic vaping pack, that are the subject of a determination by the Secretary under the relevant exemptions in the TG Regulations or the MD Regulations that the supply of the goods should be stopped. This information includes information relating to the details of the goods, details of the sponsor of the goods, the date of the determination, the reasons for the determination and any information relating to actions, or possible actions, that may be reasonable and appropriate under the Act in the interests of public health and safety.

Item 4 of the table in Schedule 2 to the Instrument specifies information relating to therapeutic goods mentioned in items 1 and 2 that are not the subject of a notice mentioned in those items. This information includes details of the goods, details of the sponsor of the goods, information about the importation, manufacture and supply of the goods, and any information relating to actions, or possible actions, that may be reasonable and appropriate under the Act in the interests of public health and safety.

The publication of this information relating to vaping goods that are, or are not, the subject of a notice or determination, promotes transparency to ensure that Australian patients and health practitioners prescribing vaping goods are able to easily identify vaping goods that meet minimum safety, quality, efficacy or performance requirements for such goods and may, therefore, be lawfully supplied in Australia.

Although the sponsor is most often a company, the sponsor may be an individual, so it may be possible to identify an individual from the information published on the TGA website. The TGA, as part of the Australian Government Department of Health and Aged Care, is an APP entity for the purposes of the Privacy Act 1988 (“the Privacy Act”). Any use or disclosure of personal information would be consistent with the Privacy Act.

The collection and use of the information specified in the Instrument by the TGA, and its disclosure, is critically important in informing the public as to the compliance of particular goods with minimum safety, quality, efficacy or performance requirements for vaping goods. In particular, it is important that the information about the sponsor of vaping goods is publicly available, to ensure patients and health practitioners are able to easily identify vaping goods that meet minimum requirements and can contact the sponsor if needed.

Attachment B

Statement of Compatibility with Human Rights

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

Therapeutic Goods (Information Specification—Therapeutic Vaping Goods and Vaping Devices) Instrument 2023

This disallowable legislative instrument 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 Legislative Instrument

Section 61 of the Therapeutic Goods Act 1989 (“the Act”) provides that the Secretary may release specified kinds of therapeutic goods information to the public, and to certain organisations, bodies, or authorities. Subsection 61(1) of the Act defines ‘therapeutic goods information’, for the purpose of section 61, as information relating to therapeutic goods which is held by the Department and relates to the performance of the Department’s functions.

The Instrument also specifies, for the purposes of subsection 61(5C) of the Act, the kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5D) of the Act. The Instrument authorises the release of therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, and components or articles used in the manufacture of therapeutic vaping goods, that are the subject of a notification (by the sponsor that the goods comply with an applicable standard, or the essential principles) or determination (by the Secretary that the goods do not comply) under the Therapeutic Goods Regulations 1990 (“the TG Regulations”) or the Therapeutic Goods (Medical Devices) Regulations 2002 (“the MD Regulations”).

Background

The public health problem

Reforms to the regulation of vapes

The Australian Government is implementing reforms to the regulation of vapes to address the growing public health problem associated with vaping. The reforms are proposed to ban the importation, manufacture and supply of disposable single use, and non-therapeutic, vapes while strengthening the regulatory controls of all therapeutic vapes. This will be achieved through amendments to the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002, the Customs Act 1901 and the Customs (Prohibited Imports) Regulations 1956, as well new and amended delegated instruments under the Act. A transitional approach will apply to the commencement of the reforms to allow a reasonable time for importers, manufacturers and suppliers to comply with the enhanced regulation, while maintaining legitimate patient access to therapeutic vaping goods for smoking cessation or the management of nicotine dependence.

In broad terms, the first stage of the reforms will:

prohibit the importation of disposable single use vapes, irrespective of therapeutic claims, subject to limited exceptions, from 1 January 2024;
prohibit the importation of non-therapeutic vapes, irrespective of nicotine content, subject to limited exceptions, from 1 March 2024;
introduce the requirement for importers to obtain a customs licence and permit to import therapeutic vapes, subject to limited exceptions, from 1 March 2024, with applications to be enabled from 1 January 2024;
end the personal importation scheme for therapeutic vapes – the scheme will cease to operate on 1 March 2024, but the importation of disposable vapes will be prohibited from 1 January 2024;
retain a limited traveller’s exception that allows persons arriving in Australia by ship or plane to carry a limited quantity of vapes for their treatment or the treatment of someone travelling with them under their care – revisions to the traveller’s exemption will commence on 1 March 2024 with restrictions on disposable vapes commencing 1 January 2024;
introduce the requirement for importers and manufacturers to notify the Secretary that therapeutic vapes intended to be imported, or released for supply in Australia, comply with relevant product standards or essential principles, as the case may be – this requirement will commence on 1 March 2024, with notifications to be enabled from 1 January 2024;
modify the exemptions relating to unregistered therapeutic vapes to require such goods to be supplied through prescription medicine supply chains to patients for smoking cessation or the management of nicotine dependence – this requirement will commence on 1 March 2024;
make minor changes to relevant product standards to facilitate the introduction of the notification and permit schemes, introduce restrictions on flavours and ensure minimum standards for device components; and

enable therapeutic vapes to be accessed by patients under the Special Access Scheme – Category C, to facilitate more timely access to unregistered therapeutic vapes and reduce regulatory burden on practitioners, while maintaining regulation commensurate with the risk.

Purpose

Subsection 5(1) and Schedule 1 to the Instrument provide for the release of specified therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, components or articles used in the manufacture of vaping goods, disposable therapeutic vapes and therapeutic cannabis vaping goods. It provides for the release of this information to persons, bodies and authorities including Commonwealth, state or territory authorities with functions relating to therapeutic goods, health or law enforcement, and the ATO, for the purpose of supporting compliance and enforcement activities relating to the importation, manufacture and supply of therapeutic vaping goods and the other goods to which the Instrument applies. Release of information to these bodies or authorities is necessary to give effect to the Government’s proposed reforms addressing the growing public health problem associated with vaping. Each body or authority plays a pivotal role in the enforcement of the proposed reforms. For example, the Australian Border Force will be responsible for seizing unlawful therapeutic vaping goods at the border. The ATO will be responsible for investigating money laundering that may be associated with the supply of unlawful therapeutic vaping goods, and otherwise enforcing tobacco excises that be may applicable to goods to which the Instrument applies.

More specifically, the kinds of therapeutic goods information that may be released to Commonwealth authorities, state or territory authorities, and the ATO includes the following:

details about the goods, including formulation, composition, design specification or presentation;
information about the importation, manufacture or supply of the goods;
information about the sponsor of the goods;
information about other persons involved, or apparently involved, in the importation, manufacture or supply of the goods;
a notice, or information about a notice, or the absence of a notice, that relates to the goods under item 15 in Schedule 5A to the TG Regulations or 2.17 in Part 2 of Schedule 4 to the MD Regulations;
a determination, or information about a determination, by the Secretary under item 15 in Schedule 5A to the TG Regulations or item 2.17 in Part 2 of Schedule 4 to the MD Regulations that relates to the goods;
information about a compliance or enforcement activity conducted, or proposed to be conducted, in relation to the goods, including but not limited to search, seizure, destruction, recall, the giving of an infringement notice, or the commencement of a civil penalty proceeding or criminal prosecution;
information or evidence provided by the sponsor to support statements made in a notice under item 15 of Schedule 5A to the TG Regulations or item 2.17 of Part 2 of Schedule 4 to the MD Regulations;
complaints, intelligence or any other information about the compliance of the goods with requirements under the Act, including but not limited to the conditions of an applicable exemption;
complaints, intelligence or any other information about the compliance of persons involved, or apparently involved, in the importation, manufacture or supply of the goods;
information about compliance with an applicable standard or the essential principles (as relevant);
a consent, or information about a consent, or the absence of a consent, that relates to the goods under sections 14, 14A, 41MA or 41MAA of the Act;
an approval, or information about an approval, or the absence of an approval, that relates to the goods under sections 19, 41HB or 41HC of the Act;
a permit, or information about a permit, or the absence of a permit, issued under regulation 5 or 5A of the Customs (Prohibited Imports) Regulations 1956 (“the Customs Regulations”) that relates to the goods;
information relating to an investigation or finding about compliance of the goods with regulations 5 or 5A of the Customs Regulations;
information relating to the examination or testing, and the results of the examination or testing, of a sample of the goods.

The kinds of therapeutic goods information that may be released to the public would include, for example:

details of the goods, including strength and presentation;
details of the sponsor of the goods;
the date notice of compliance with standards was given by the sponsor to the Secretary;
information relating to the compliance of the goods with the applicable standards, essential principles, or any consent given in relation to the goods under section 14, 14A, 41MA or 41MAA of the Act;
other information relating to compliance of the goods with the conditions of the exemption under which the notice was given;
for those goods that are the subject of a determination under the relevant exemption item by the Secretary, information about the date of the determination, the reasons for the determination and actions, or possible actions, that may be reasonable and appropriate to take under the Act in the interests of public health and safety;
for those goods that are not the subject of a notice to the Secretary, information about the importation, manufacture and supply of the goods and actions, or possible actions, that may be reasonable and appropriate to take under the Act in the interests of public health and safety.

Human rights implications

The instrument engages the right to health in Article 12 of the International Covenant on Economic, Social and Cultural Rights (“the ICESCR”) and the right to protection against arbitrary and unlawful interferences with privacy in Article 17 of the International Covenant on Civil and Political Rights (“the ICCPR”).

Right to health

Article 12 of the ICESCR promotes the right of all individuals to enjoy the highest attainable standards of physical and mental health, and includes an obligation to take reasonable measures within available resources to progressively securer 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. Vape marketing and use in the community has increased rapidly in recent years, particularly among young people and poses a major risk to population health and Australia’s success in tobacco control.

The reforms to the regulation of vaping products takes positive steps to promote the right to health by supporting reforms to the regulation of vapes. These reforms will support the availability of therapeutic vaping goods to persons who require these goods for smoking cessation or the management of nicotine dependence, while ensuring that access is supervised by a health practitioner and that minimum standards for the safety and quality of therapeutic vaping goods are met.

Collectively, the reforms are intended to arrest the increasing uptake of recreational vaping, especially by youth and young adults. Restricting the domestic supply of non-therapeutic vapes while still allowing for therapeutic use strikes an appropriate balance between the health concerns posed by vaping and the need to provide legitimate patient access to Australians combating smoking addiction or nicotine dependence. Ensuring vapes are only accessed under 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.

The new framework will support the following public health objectives to:

arrest the uptake of vapes, other than for therapeutic purposes, especially in youth and young adults aged below 25 years;
counteract the marketing of vapes to youth and young adults, especially through product features such as flavours and packaging;
prevent nicotine dependence and reduce the risk of future tobacco use; and
safeguard public health by requiring unregistered therapeutic vapes to meet minimum quality and safety standards.

The reforms will support 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.

The Instrument takes positive steps to promote the right to health by facilitating the release of therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, components or articles used in the manufacture of vaping goods, disposable therapeutic vapes and therapeutic cannabis vaping goods. The release of such information to Commonwealth and state or territory authorities with responsibility for therapeutic goods, health or law enforcement, or the ATO, ensures there is an effective compliance and enforcement scheme in place to identify and prevent the importation or supply of unlawful vaping goods that do not meet minimum standards for quality, safety and efficacy or performance.

The release of therapeutic goods information relating to therapeutic vaping goods, therapeutic vaping kits, goods in a therapeutic vaping pack, starting materials, components or articles used in the manufacture of vaping goods, that are the subject of a notification (that the goods comply with applicable standards or the essential principles) or determination (by the Secretary that the goods do not comply) under the regulations ensures that Australian patients and health practitioners prescribing vaping goods are able to easily identify vaping goods that meet minimum safety, quality, efficacy and performance requirements for such goods and lawfully supply these goods in Australia.

Right to protection against arbitrary and unlawful interferences with privacy

Article 17 of the ICCPR provides for the right of every person not to be subjected to arbitrary or unlawful interference with privacy. The prohibition on interference with privacy prohibits unlawful or arbitrary interferences with a person’s privacy, family, home and correspondence. It also prohibits unlawful attacks on a person’s reputation. Limitations on the right to privacy must be according to law and not arbitrary, i.e. limitations must be reasonable and necessary in the particular circumstances, as well as proportionate to the objectives the limitations seek to achieve.

The information specified in the Instrument to be released to the public that may contain personal information may include the name of the sponsor of the vaping goods or starting materials or articles or components used in the manufacture of the vaping goods, which is the person who imports the goods into Australia, exports the goods from Australia, or manufactures the goods in Australia.

The collection and use of the information specified in the Instrument by the TGA, and its disclosure, is critically important in informing the public as to the compliance of vaping goods with minimum safety, quality, efficacy or performance requirements for vaping goods. In particular, it is important that the information about the sponsor of vaping goods is publicly available, to ensure patients and health practitioners are able to easily identify vaping goods that meet minimum requirements and can contact the sponsor if needed.

As such, the disclosure of the information would not be an arbitrary or unlawful interference with a person’s privacy under Article 17 of the ICCPR, as the disclosure would be reasonable given it is appropriate and justified for the public to know the identify of a sponsor, even if the sponsor is an individual, and the disclosure would be necessary and proportionate to the objective of ensuring that vaping goods imported or supplied in Australia meet minimum safety, quality, efficacy or performance requirements for such goods.

Conclusion

The Instrument is compatible with human rights because it promotes the right to health in Article 12 of the ICESCR and any engagement with the right to privacy in Article 17 of ICCPR is reasonable, necessary and proportionate.

Administered by Department of Health, Disability and Ageing

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