This article applies to organisations in Australia that employ medical practitioners, nurse practitioners and pharmacists.
Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth)
Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024 (Cth)
Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024 (Cth)
Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024 (Cth)
On 1 July 2024, relevant parts of the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (Cth) (the Amending Act) amended the Therapeutic Goods Act 1989 (Cth) (the Act).
To coincide with the changes introduced by the Amending Act, on 1 July 2024 the Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024 (Cth) (the Authorisation), the Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024 (Cth) (the Determination) and the Therapeutic Goods (Vaping Goods—Other Indications) Determination 2024 (Cth) (the Other Indications Determination) also commenced operation.
Overview
To reduce the rates of vaping (particularly among youth and young adults), and to prevent long term adverse effects on population health, the Amending Act has amended the Act to introduce new offences relating to the supply and advertisement of non-therapeutic and disposable vaping goods.
It is important to note that despite these new offences applying to the supply and advertisement of such vaping goods, the Act still continues to preserve legitimate patient access to therapeutic vaping goods for smoking cessation and the management of nicotine dependence under appropriate health practitioner supervision. Importantly, therapeutic vaping goods continue to be available and subject to regulation under the Act in line with other medicines and therapeutic goods.
From 1 July 2024 until 30 September 2024, vaping goods are to only be supplied through the same supply chains that apply to goods containing substances included in Schedule 4 to the Poisons Standard (prescription medicines). Essentially until 30 September 2024, individuals will need a prescription to purchase vapes containing nicotine and individuals will need to speak to a medical practitioner or a nurse practitioner to access zero-nicotine vapes.
Supplying vaping goods
Newly introduced section 41QB(1) makes it an offence for a person to supply vaping goods in Australia (unless an exception set out in section 41QB applies). Section 41P of the Act defines a vaping good as any of the following goods:
- a vaping substance;
- a vaping accessory;
- a vaping device;
- goods the presentation of which includes an express or implied representation that the goods are of a kind referred to in the first, second or third point above;
- goods that are, or are included in a class of goods that are, determined to be vaping goods under section 41P(3) of the Act.
Breach of section 41QB(1) incurs a penalty of imprisonment for 7 years or 5000 penalty units (currently $1,565,000), or both. Importantly we note that section 41QB sets out a number of exceptions to the offence in section 41QB, to allow for the therapeutic wholesale and retail supply chain (which are discussed in more detail below).
Exceptions
Most relevantly, the Act provides that the offence in section 41QB does not apply if sections 41QB(6), 41QB(7), and 41QB(8) apply (and these exceptions apply to the wholesale supply chain). Furthermore, the Act provides that the offence in section 41QB does not apply if sections 41QB(9), 41QB(10), and 41QB(11) apply (and these exceptions apply to the retail supply chain).
By way of example, section 41QB(9) of the Act provides that the offence in section 41QB does not apply in relation to the supply of the vaping goods by the person if:
- the vaping goods are therapeutic goods that are entered on the Register; or
- both of the following apply:
- the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of section 18(1) or an exempt device under regulations made for the purposes of section 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption;
- the vaping goods are not the subject of a determination by the Secretary, published on the Department’s website, that the supply of the goods be stopped or should cease because the Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods; or
- the vaping goods are covered by a determination made by the Minister under section 41R of the Act.
In short, section 41R of the Act provides that the Minister may, by legislative instrument determine that specified vaping goods, or a specified class of vaping goods, may be supplied or possessed in Australia. We note that the
Determination outlines the circumstances in which specified vaping goods may be possessed and supplied. The Determination may be viewed here.
In addition, organisations should be aware that section 41QB(10) provides that the offence in section 41QB does not apply in relation to the supply of the vaping goods by the person if:
- the person is a pharmacist; or
- the person is a medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 4 to the current Poisons Standard under a law of the State or Territory in which the supply occurs.
Finally we note that section 41QB(11) of Act provides that the offence in section 41QB does not apply in relation to the supply of the vaping goods by the person if:
- the supply is:
- to another person for use by that person for smoking cessation, management of nicotine dependence or another indication determined by the Minister under section 41RA (as set out in the Other Indications Determination); or
- to another person, who is the carer of a third person, for use by the third person for smoking cessation, management of nicotine dependence or another indication determined by the Minister under section 41RA (as set out in the Other Indications Determination); and
- if the vaping goods are, or contain, a vaping substance—the vaping substance is in final dosage form; and
- the supply is:
- in accordance with this Act (apart from this section); and
- consistent with the person’s authority to supply the vaping goods under a law of the State or Territory in which the supply occurs.
The Other Indications Determination can be accessed here.
Organisations should ensure that relevant clinical staff familiarise themselves with the full suite of exceptions set out in section 41QB of the Act.
Advertising vaping goods
Importantly, a person who advertises, or causes the advertising of vaping goods that are not covered by an authorisation under newly introduced section 42DZC of the Act, or despite having an authorisation, the advertising does not comply with requirements or conditions specified in the authorisation, may be committing an offence in section 42DZD of the Act. A breach of section 42DZD incurs a sanction of imprisonment for 7 years or 5,000 penalty units (currently $1,565,000), or both.
We note that the Authorisation is made under section 42DZC of the Act. The Authorisation authorises the advertising, or a class of advertising, of specified vaping goods or a specified class of vaping goods for the purposes of the advertising of such goods or classes of goods in appropriate circumstances and subject to conditions. By way of example, the advertising of notified vaping goods that is authorised includes:
- advertising that is advice or information given directly to a patient, by one or more of the following persons, in the course of the treatment of the patient for smoking cessation or the management of nicotine dependence:
- a medical practitioner;
- a nurse practitioner;
- a pharmacist.
Organisations should ensure their relevant clinical staff familiarise themselves with the conditions of advertising.
1 October 2024 changes for pharmacists
We note that on 1 October 2024, the Amending Act is scheduled to amend the Therapeutic Goods (Medicines and OTG – Authorised Supply) Rules 2022 (Cth) to permit pharmacists to supply certain nicotine vaping goods without a prescription in certain circumstances and subject to certain conditions being satisfied.
Conclusion
Organisations should circulate this training brochure to their medical practitioner, nurse practitioner and pharmacy staff to ensure they are made aware of the new changes regarding the supply and advertising of vaping goods from 1 July 2024 as discussed above.
