Malarndirri McCarthy (NT, Australian Labor Party, Assistant Minister for Indigenous Australians) Share this | Hansard source

I table a supplementary explanatory memorandum relating to the government amendments to be moved to this bill. I move:

(1) Clause 2, page 2 (table item 1, column 1), omit "1 to 3", substitute "1 to 4".

(2) Clause 2, page 2 (table item 2), omit the table item, substitute:

(3) Clause 2, page 2 (at the end of the table), add:

(4) Clause 3, page 2 (after line 12), at the end of the clause, add:

Note 1: Subject to item 20 of Schedule 4, the provisions of the Therapeutic Goods (Medicines and OTGAuthorised Supply) Rules 2022 amended or inserted by this Act, and any other provisions of that instrument, may be amended or repealed by an instrument made under subsection 19(7A) of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003).

Note 2: Subject to item 20 of Schedule 4, the provisions of the Therapeutic Goods (Poisons StandardJune 2024) Instrument 2024 amended or inserted by this Act, and any other provisions of that instrument, may be amended or repealed by an instrument made under subsection 52D(2) of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003).

Note 3: Subject to item 20 of Schedule 4, the provisions of the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990 amended or inserted by this Act, and any other provisions of those regulations, may be amended or repealed by regulations made under section 63 of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003).

(5) Page 2 (after line 12), after clause 3, insert:

4 Review of operation of amendments

(1) The Minister must cause an independent review to be conducted of the operation of the amendments made by Schedules 1, 3 and 4 to this Act and any regulations or other legislative instruments made for the purposes of those amendments.

(2) The review must commence no later than 1 July 2027.

(3) The persons who conduct the review must give the Minister a written report of the review within 6 months after the commencement of the review.

(4) The Minister must cause a copy of the report to be tabled in each House of the Parliament within 15 sitting days of that House after the report is given to the Minister.

(6) Schedule 1, item 11, page 7 (line 10), after "classes of vaping goods.", insert "In deciding whether to give a consent, the Secretary must comply with the decision-making principles (if any) determined by the Minister by legislative instrument.".

(7) Schedule 1, item 11, page 18 (after line 14), after subsection 41QC(11), insert:

Exception possession for personal use

(11A) Subsections (1) to (3) and (10) and (11) do not apply in relation to the possession of a quantity of a kind of vaping goods by the person if:

(a) the vaping goods have been lawfully supplied to the person; and

(b) the vaping goods are for use by the person personally; and

(c) the quantity is less than 5 times the commercial quantity of that kind of vaping goods.

Note: The person bears an evidential burden in relation to the matters in subsection (11A): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

(8) Schedule 1, item 11, page 18 (line 15), at the end of the heading to subsection 41QC(12), add "general".

(9) Schedule 1, item 11, page 20 (line 2) to page 23 (line 3), omit section 41QD, substitute:

41QD Offences and civil penalty provision — possessing less than commercial quantity of vaping goods

Offences

(1) A person commits an offence if:

(a) the person is a retailer in relation to retail premises in Australia; and

(b) the person possesses a quantity of a kind of vaping goods at the retail premises; and

(c) the quantity is less than the commercial quantity of that kind of vaping goods.

Penalty: Imprisonment for 12 months or 500 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Absolute liability applies to paragraph (1)(b).

(3) A person commits an offence of strict liability if:

(a) the person is a retailer in relation to retail premises in Australia; and

(b) the person possesses a quantity of a kind of vaping goods at the retail premises; and

(c) the quantity is less than the commercial quantity of that kind of vaping goods.

Penalty: 60 penalty units.

Civil penalty provision

(4) A person contravenes this subsection if:

(a) the person is a retailer in relation to retail premises in Australia; and

(b) the person possesses a quantity of a kind of vaping goods at the retail premises; and

(c) the quantity is less than the commercial quantity of that kind of vaping goods.

Maximum civil penalty:

(a) for an individual—1,000 penalty units; and

(b) for a body corporate—10,000 penalty units.

(5) A person who contravenes subsection (4) in relation to a kind of vaping goods commits a separate contravention of that subsection in respect of each unit of the quantity of vaping goods of that kind possessed by the person at the retail premises in Australia.

Note: For unit of vaping goods, see subsection 3(1).

Exceptions general

(6) Subsections (1) to (5) do not apply if subsections (7) and (8) apply in relation to the possession of the vaping goods by the person.

Note: The person bears an evidential burden in relation to the matters in subsections (7) and (8): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

(7) This subsection applies in relation to the possession of the vaping goods by the person if:

(a) the vaping goods are therapeutic goods that are entered on the Register; or

(b) both of the following apply:

(i) the vaping goods are therapeutic goods that are exempt goods under regulations made for the purposes of subsection 18(1) or an exempt device under regulations made for the purposes of subsection 41HA(1), and the sponsor has given the Secretary a notice in compliance with the exemption;

(ii) 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

(c) the vaping goods are covered by a determination made by the Minister under section 41R.

(8) This subsection applies in relation to the possession of the vaping goods by the person if:

(a) both of the following apply:

(i) the person is a pharmacist, 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 person possesses the goods;

(ii) the possession of the goods is in accordance with the licence or authority; or

(b) both of the following apply:

(i) the Secretary has given the person a consent under subsection 41RC(1) to possess the vaping goods;

(ii) the possession is in accordance with the consent; or

(c) in the case of vaping goods that are covered by a determination made by the Minister under section 41R:

(i) the person is specified in the determination, or is included in a class of persons that is specified in the determination, in relation to those goods; and

(ii) the possession is in accordance with the determination.

Exception possession for personal use

(9) Subsections (1) to (5) do not apply in relation to the possession of a quantity of a kind of vaping goods by the person if:

(a) the vaping goods are for use by the person personally; and

(b) the quantity is not more than the permitted quantity of that kind of vaping goods.

Note: The person bears an evidential burden in relation to the matters in subsection (9): see subsection 13.3(3) of the Criminal Code and section 41QE of this Act.

Definitions

(10) In this section:

permitted quantity of a kind of vaping goods means the quantity of that kind of vaping goods prescribed by the regulations.

retailer in relation to retail premises in Australia means any of the following:

(a) an owner, lessee or occupier of retail premises in Australia;

(b) a person conducting a business or undertaking at, or in connection or association with, retail premises in Australia;

(c) a director, officer or agent of a person referred to in paragraph (a) or (b);

(d) a person performing work in any capacity (including, but not limited to, an employee or a contractor) for, or on behalf of, a person referred to in paragraph (a), (b) or (c) at, or in connection or association with, retail premises in Australia.

retail premises means premises:

(a) from which goods or services are available for supply, or are supplied, to a consumer; or

(b) that are used in connection with the supply of goods or services to a consumer;

(whether or not the premises are used wholly or predominantly for that purpose).

Note: For premises, see subsection 3(1).

(10) Schedule 1, item 11, page 25 (after line 13), after subsection 41RC(2), insert:

(2A) In making a decision under subsection (1), the Secretary must comply with the decision-making principles (if any) determined under subsection (2B).

(2B) The Minister may, by legislative instrument, determine principles (decision-making principles) that the Secretary must comply with in making a decision under subsection (1).

(2C) Without limiting subsection (2B), the decision-making principles may set out any of the following:

(a) circumstances in which a consent under subsection (1) must not be given;

(b) matters that must be taken into account in making a decision under subsection (1);

(c) matters that must not be taken into account in making a decision under subsection (1);

(d) matters that may be taken into account in making a decision under subsection (1).

(11) Schedule 1, item 27, page 29 (line 8) to page 30 (line 3), section 42DZ to be opposed.

(12) Schedule 1, item 27, page 30 (lines 23 to 28), omit subsections 42DZC(1) and (2), substitute:

Secretary may authorise advertising

(1) The Secretary may, by legislative instrument, authorise the advertising, or a class of advertising, of specified vaping goods or a specified class of vaping goods.

(13) Schedule 1, item 27, page 31 (lines 1 to 11), omit subsection 42DZC(3).

(14) Schedule 1, item 27, page 31 (after line 14), insert:

(5) Without limiting subsection (4), conditions in an authorisation of advertising may relate to any of the following:

(a) the nature of the audience to which the advertising is targeted;

(b) the form of the advertising;

(c) the content of the advertising;

(d) representations or information on:

(i) the labels of specified vaping goods or a specified class of vaping goods; or

(ii) the packages in which specified vaping goods or a specified class of vaping goods are contained; or

(iii) any material included with the package in which specified vaping goods or a specified class of vaping goods are contained.

(15) Schedule 1, item 27, page 31 (lines 15 to 20), omit subsections 42DZC(5) and (6).

(16) Schedule 1, item 55, page 50 (lines 8 to 12), omit the item, substitute:

55 Application of amendment

Part 6-2A of the Therapeutic Goods Act 1989, as inserted by item 54 of this Schedule, applies in relation to the following:

(a) a thing (including vaping goods) that is seized by an authorised person, under a warrant issued under section 50 of that Act, on or after the commencement of this item;

(b) vaping goods that were seized by an authorised person, under a warrant issued under section 50 of that Act, before the commencement of this item, if the vaping goods are in the custody of the authorised person immediately before that commencement.

(17) Schedule 1, Part 4, page 50 (after line 18), at the end of the Part, add:

57A Subsection 60(1) (at the end of the definition of initial decision )

Add:

; or (n) to give directions under subsection 42YT(2).

57B After subsection 60(2D)

Insert:

(2E) If the Secretary or a delegate of the Secretary makes a decision to give directions under subsection 42YT(2), a person is not entitled to request the Minister to reconsider the decision unless the person is the person to whom the directions were given.

(18) Schedule 1, item 100, page 61 (line 13), after "approval", insert "or authority".

(19) Schedule 1, page 61 (after line 24), after item 100, insert:

101A Subparagraph 22(7)(b)(ii)

After "approval", insert "or authority".

(20) Schedule 1, item 102, page 62 (line 7), after "approval", insert "or authority".

(21) Schedule 1, item 106, page 62 (line 26), after "approval", insert "or authority".

(22) Schedule 1, item 111, page 63 (lines 16 and 17), omit "exemptionor approval", substitute "exemption, approval or authority".

(23) Schedule 1, item 111, page 63 (after line 25), after subparagraph 41MN(9)(b)(iii), insert:

(iiia) a condition of an authority under section 41HC; or

(24) Schedule 1, item 111, page 64 (after line 13), after subparagraph 41MN(9A)(b)(iii), insert:

(iiia) a condition of an authority under section 41HC; or

(25) Schedule 1, item 111, page 64 (after line 25), after subparagraph 41MN(9B)(b)(iii), insert:

(iiia) a condition of an authority under section 41HC; or

(26) Schedule 1, item 112, page 65 (after line 5), after subparagraph 41MNA(2A)(b)(iii), insert:

(iiia) a condition of an authority under section 41HC; or

(27) Page 69 (after line 15), at the end of the Bill, add:

Schedule 4 — Supply of therapeutic vaping goods by pharmacists without prescription

Part 1 — Amendments

Therapeutic Goods Act 1989

1 Subparagraph 41QB(7)(d)(i)

Omit "Schedule 4", substitute "Schedule 3".

2 Paragraphs 41QB(8)(b) and (10)(b)

Omit "Schedule 4", substitute "Schedule 3".

3 Subparagraph 41QC(14)(d)(i)

Omit "Schedule 4", substitute "Schedule 3".

4 Subparagraph 41QD(8)(a)(i)

Omit "Schedule 4", substitute "Schedule 3".

Therapeutic Goods (Medical Devices) Regulations 2002

5 Schedule 4 (table item 2.17, column headed "Conditions")

Omit "Schedule 4 to the current Poisons Standard" (wherever occurring), substitute "Schedule 3 to the current Poisons Standard".

Therapeutic Goods (Medicines and OTG Authorised Supply) Rules 2022

6 Paragraph 5A(2)(c)

After "medical practice", insert "or good nursing practice (as the case requires)".

7 Paragraphs 5A(2)(d) and (e)

After "medical practitioner", insert "or nurse practitioner".

8 Subsection 5A(3) (heading)

Repeal the heading, substitute:

Supply by a pharmacist with prescription

9 Subsection 5A(3)

Omit "health practitioner", substitute "pharmacist".

10 Subsection 5A(4)

Omit "health practitioner" (wherever occurring), substitute "pharmacist".

11 At the end of section 5A

Add:

Supply by a pharmacist without prescription

(5) A pharmacist is authorised to supply a therapeutic good to a patient where:

(a) the therapeutic good is within the class of therapeutic goods specified in column 2 of an item in the table in Schedule 1A; and

(b) the therapeutic good is in the dosage form specified in column 3 of that item; and

(c) the therapeutic good is to be administered by the route specified in column 4 of that item; and

(d) the supply is for the indication specified in column 5 of that item; and

(e) the supply is to a patient who is 18 years of age or over; and

(f) the pharmacist requests and sights evidence of the patient's identity and age; and

(g) the quantity of the goods does not exceed the quantity that is reasonably required for a patient's therapeutic use for 1 month and that quantity is supplied to the patient only once in a month; and

(h) the concentration of nicotine in the goods does not exceed 20 mg/mL; and

(i) the conditions specified in subsections (6) and (7) are satisfied.

(6) The pharmacist must:

(a) inform the patient, or a parent or a guardian of the patient, that the therapeutic good is not a listed good or registered good; and

(b) obtain informed consent from the patient, or a parent or a guardian of the patient, in relation to, and before, the supply of the therapeutic good; and

(c) supply the therapeutic good in accordance with good pharmacy practice; and

(d) provide professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines; and

(e) provide contact details about smoking cessation support services to the patient; and

(f) if the pharmacist becomes aware that the patient has suffered an adverse event in relation to the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good about the adverse event in accordance with the reporting guidelines set out in the SAS Guidance; and

(g) if the pharmacist becomes aware of a defect in the therapeutic good—notify the Therapeutic Goods Administration and the sponsor of the therapeutic good in accordance with the reporting guidelines set out in the SAS Guidance.

(7) The pharmacist must store the therapeutic good in a part of the pharmacy premises to which the public does not have access.

Therapeutic Goods (Poisons Standard June 2024) Instrument 2024

12 Subsection 49(1) (table item 27, column 1)

Before "4", insert "3 or".

13 In the appropriate position in Schedule 3

Insert:

NICOTINE in therapeutic vaping goods (within the meaning of the Therapeutic Goods Regulations 1990) in final dosage form for smoking cessation or the management of nicotine dependence when:

(a) for supply to persons aged 18 years and over; and

(b) the pharmacist requests and sights evidence of the patient's identity and age; and

(c) the pharmacist provides professional advice to the patient on alternative cessation supports and therapies, appropriate dose and frequency depending on age, weight and severity of condition, length of treatment, suitable titration, and interactions with other medicines; and

(d) the pharmacist provides contact details about smoking cessation support services to the patient; and

(e) the quantity of the goods does not exceed the quantity that is reasonably required for a patient's therapeutic use for 1 month and that quantity is supplied to the patient only once in a month; and

(f) the concentration of nicotine in the goods does not exceed 20 mg/mL; and

except:

(g) in preparations for oromucosal or transdermal administration for human therapeutic use when included in the Register as an aid in withdrawal either from tobacco smoking or nicotine vaping; or

(h) in tobacco prepared and packed for smoking.

14 Schedule 4 (entry for "NICOTINE")

Repeal the entry, substitute:

# NICOTINE in preparations for human use except:

(a) when included in Schedule 3; or

(b) in preparations for oromucosal or transdermal administration for human therapeutic use when included in the Register as an aid in withdrawal either from tobacco smoking or nicotine vaping; or

(c) in tobacco prepared and packed for smoking.

15 Schedule 7 (paragraph (a) of the entry for "NICOTINE")

Before "4", insert "3 or".

16 Index (entry for "NICOTINE")

After:

Schedule 4

insert:

Schedule 3

Therapeutic Goods Regulations 1990

17 Schedule 5A (table item 15, column 3)

Omit "Schedule 4 to the current Poisons Standard" (wherever occurring), substitute "Schedule 3 to the current Poisons Standard".

Part 2 — Application and other provisions

18 Application of amendments

The amendments made by this Schedule apply in relation to the import, manufacture, possession or supply of therapeutic goods on or after the day this Schedule commences.

19 Amendments of current Poisons Standard

Provisions of the Therapeutic Goods Act 1989, or the Therapeutic Goods Regulations 1990, in relation to the requirements or procedure for amending the current Poisons Standard (within the meaning of that Act) do not apply to the amendments of the current Poisons Standard made by this Schedule.

20 Restrictions on amending instruments

(1) A legislative instrument made under the Therapeutic Goods Act 1989 (other than paragraph 52D(2)(b)) that:

(a) is made on or after the commencement of this Schedule; and

(b) amends or repeals the amendments made by this Schedule (other than the amendments of the current Poisons Standard);

must not commence before the end of the period in which the instrument could be disallowed in either House of the Parliament.

(2) Subitems (3) and (4) apply in relation to a legislative instrument made under paragraph 52D(2)(b) of the Therapeutic Goods Act 1989 that:

(a) is made on or after the commencement of this Schedule; and

(b) amends or repeals the amendments of the current Poisons Standard made by this Schedule.

(3) Despite subsection 52D(4A) of the Therapeutic Goods Act 1989, section 42 (disallowance) of the Legislation Act 2003 applies to the legislative instrument, to the extent that it amends or repeals the amendments of the current Poisons Standard made by this Schedule.

(4) The legislative instrument must not commence before the end of the period in which it could be disallowed in either House of the Parliament.

(5) A person must not make an application under subsection 52EAA(1) of the Therapeutic Goods Act 1989 for:

(a) an amendment of the entry relating to nicotine inserted into Schedule 3 to the current Poisons Standard by this Schedule; or

(b) an amendment of the entry relating to nicotine inserted into Schedule 4 to the current Poisons Standard by this Schedule; or

(c) any amendment related to the entries relating to nicotine referred to in paragraphs (a) and (b) of this subitem.

(6) This item is repealed at the end of the day the report of the review required by section 4 of this Act is tabled in both Houses of the Parliament.