Malarndirri McCarthy (NT, Australian Labor Party, Assistant Minister for Indigenous Australians) Share this | Link to 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Supply) Rules 2022 amended or inserted by this Act, and any other provisions of that instrument, may be amended or repealed by an instrument made under subsection 19(7A) of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003).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2024) Instrument 2024 amended or inserted by this Act, and any other provisions of that instrument, may be amended or repealed by an instrument made under subsection 52D(2) of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003).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Regulations 1990 amended or inserted by this Act, and any other provisions of those regulations, may be amended or repealed by regulations made under section 63 of the Therapeutic Goods Act 1989 (see subsection 13(5) of the Legislation Act 2003).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.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I'm keen to get a few answers in relation to the amendments that you've just moved. They relate to the change in position of the government from proposing an F4 prescription model for vaping products to an F3 pharmacy model, which is something that has happened in the later stages of this bill and subsequent to its passage in its previous form through the House of Representatives.

Minister, I'm keen to understand: in the last sitting period, the House of Representatives put through a version of the bill, and you are now seeking to amend the bill quite substantially. Who did the government consult with before making the decision to move to the pharmacy F3 prescription model that is currently being proposed by these amendments?

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

These are government amendments that have come out of good faith consultations, Senator Ruston, with the crossbench. These amendments strengthen the laws and clarify the intent that has always been in the laws to return vaping to its original state of purpose of helping hardened smokers to quit by cracking down on the commercial sale and supply of recreational vapes while ensuring that those people who really need a therapeutic vape to help them quit can get one.

We've also listened to feedback generally about how important it is for people to have quick access to a quit consultation with a healthcare professional when they seek it. We know that a pharmacy is often the most accessible place people turn to when they need health advice, especially in remote and rural areas. After a 10-month period of having those quick conversations with their GP, we will expand the range of healthcare professionals who can have those conversations and recommend whether a therapeutic vape is needed to include pharmacists. I am conscious of the media commentary around the changes, but we do have the support of thousands of pharmacies across the country in relation to this. This has been a long process, one that Minister Mark Butler has worked diligently on with the health sector, the AMA, GPs and pharmacies, so we are prepared to move these amendments.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I note you made the comment in your contribution that thousands of pharmacies around Australia support your change from an S4 to an S3 model. How many pharmacists did the government consult with before changing its mind around this model and moving to an S3?

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

I believe I've just answered that.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Would it be possible for you to provide advice to this chamber as to who those thousands of pharmacists were?

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

It has been public consultation, very much been on the record. We've seen that through the Senate and the processes that have gone through the parliament. The consultations that have taken place across the country have been very clear through what I've said here and what the minister has said in media interviews.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

When did the government advise the peak representative pharmaceutical bodies of its intention to change the model for access to vaping products?

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

There's no doubt, since this came in as a discussion at the end of last year and even as early as this year, that this was going to be a very difficult task but one that was necessary for our country in terms of ensuring the safety of children in particular. So the conversations, the inquiries and the meetings, as I outlined in my initial response to you, have been fully on the record. That's all I have to say on it.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I'm keen to be really clear about what I'm asking you. When were the peak pharmacy bodies in Australia advised of the decision of the government—obviously in consultation with your agreement with the Greens—to change its policy position, which is reflected in the amendments to this bill?

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

We are in constant conversation with the pharmacy sector and with the medical fraternity more broadly across the country. There is a very complete understanding of the machinations of the parliament and the differences that different parties may hold on particular pieces of legislation. They trust that those conversations we have as political leaders with those political parties will still take on board the issues that those areas and those sectors have raised with us. This is not a surprise. This is something that has been clearly supported, and the minister is very confident in that support.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Were the Pharmacy Guild or the Pharmaceutical Society of Australia advised of the decision by the government to move to an S3 model for the sale of vapes in Australia prior to the announcement on Monday by the Greens?

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

Senator, I can say this. The Pharmacy Guild of Australia stood beside the minister for health only a month ago, and Trent Twomey said:

… Australia's 6,000 community pharmacies stand ready, willing, and able to work with both the Commonwealth and State and Territory Governments to not only keep vapes out of the hands of our children … but also to increase the accessibility of smoking cessation alternatives.

This is exactly what our laws here will achieve.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Just to be very clear: are you telling this parliament, this chamber, that the Pharmacy Guild of Australia supports the decision of the government to move to an S3 model for the sale of vapes in Australia? That's what you appear to have just said, although I don't think you specifically and explicitly said that, but I would like you to advise this chamber: have you ever had receipt from the Pharmacy Guild to say that they support your decision to move to the S3 model? What you've just described was a commentary from Mr Twomey when an S4 model was before this chamber and was the government's policy. Have you any evidence whatsoever to substantiate your claim that the Pharmacy Guild support the decision of this government to change their position about the need for a GP prescription to access vapes in this country?

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

Senator Ruston, your question was in relation to consultation with the pharmacy and Pharmacy Guild, which is what I responded to. In terms of your specific question about whether there is support now, I can certainly take that question on notice as to whether the minister has something in writing, and I'm more than happy to get back to you on that.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Just for the sake of being absolutely clear about what I'm talking about here, I am talking about a decision that was communicated to the Australian public on Monday that a deal had been reached between the government and the Australian Greens to move the model by which Australians can access vapes from requiring a prescription from a GP or a nurse practitioner to no longer requiring that. The requirement now, according to the government's amendments to this legislation, is that pharmacies around Australia will be asked to supply vapes to Australians without a script, and they will also be required to be the disposal point for vapes once they've been used. Now, this is a significant change in what has been out as public consultation. The exposure draft of the bill for the entire time that it out in community consultation was predicated on a prescription model, and that prescription model is something that has been in place in Australia for a very long time. What we've seen is a significant change.

I want to make it very clear, minister: you are conflating two issues that are not the same. I'm asking you about the change of position by the government that was announced to the Australian public on Monday. I'm not talking about consultation that happened prior to that. I'm not talking about what guild may have referred to or commented about, or about the previous position of the government. I am very keen to understand what has transpired prior to the decision of the government to agree with the Greens to change the model of prescription, dispensing and disposal of vapes in Australia that was announced on Monday.

It's pretty clear, if you read the media over the last two days, that the Pharmacy Guild and the Pharmacy Society of Australia do not want to sell vapes. They do not want to be the disposal units for used vapes. They've made it very clear. While I understand that you're not the minister and you can only report what you have been advised from the senior minister in this place, I think it is very disingenuous for the government to suggest that the pharmacies across Australia are supportive of the decision by the government to do a deal with the Greens to change the way vapes are available in Australia. But what is worse than this is, despite your preparedness to admit to it, the Pharmacy Guild, the Pharmacy Society and the 6,000 businesses that make up our frontline community pharmacists around this country did not know anything about the deal that you had done with the Greens until they saw the release from the Greens on Monday afternoon. On Monday afternoon the Greens made a release to say that they had done a deal, and that was when Australia found out that you were going to change the mechanism through which vapes were going to be made available in Australia. Subsequent to that, pharmacies have come out and said they don't want to sell. They say it's completely unworkable, and there are a whole heap of concerns that are now coming out, because there has been no consultation with the pharmacy sector.

Once again, we have got a government making a policy change that affects 6,000 small businesses around the country, and they haven't even bothered to speak to them. They have not bothered to speak to them, they have not bothered to hear their concerns, they have not even bothered to think through the logistical implications of doing this. Minister, what is the maximum quantity of a vaping product that a pharmacist can supply to a patient in a single transaction?

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

I think the only ones who are being disingenuous here, Senator, are the Liberals. Where have you been in the last six months in any of these consultations? We are so close to getting this piece of legislation across. You know, and every single senator on that side who is going to oppose this knows, how important this is to our country, especially the health of our children. You also know, from the answers that I provided here, that we have had continuous discussions with the Pharmacy Guild, with pharmacies, with GPs and with the medical fraternity. We know that, across every state and territory jurisdiction, there is support behind this, from every chief health officer and every public health group including the AMA, the Royal Australian College of GPs, the Cancer Council and many others. So please let's have a really good look at who's being disingenuous here.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Does the Pharmacy Guild support this amendment?

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

Please repeat the question, Senator.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Are you refusing to answer my question?

Glenn Sterle (WA, Australian Labor Party) Share this | Link to this | Hansard source

Order! The minister is not refusing. She politely asked you to repeat the question, because I saw in the corner of my eye the minister was seeking—

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

My sincere apologies.

The TEMPORARY CHAIR: Thank you. Back to square one. We'll play fair.

I'm happy to play fair. You know that, Temporary Chair Sterle.

The TEMPORARY CHAIR: Yes. That's why I was shocked.

I'm for fair play, just like you. I said: does the Pharmacy Guild support your amendment that you've just moved?

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

I am certainly advised that thousands of pharmacies support our amendment.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Could I perhaps ask again: does the Pharmacy Guild support the government's amendment?

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

As I responded earlier, in terms of any written documentation that has been provided to the minister—if there has been any—I am more than happy to take that on notice and table that if appropriate.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Does the Pharmaceutical Society of Australia support your amendment?

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

We are certainly working very closely with them. That is my advice.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Could I just get it clear: you're working closely with them on something that you're going to ask this chamber to vote on by midday today, so you're going to guillotine this but you're working closely on it? It doesn't seem like there's much working closely when the decision's going to be made by 12 o'clock because you've chosen to guillotine this particular bill.

Before we were talking about that, I asked you: what is the maximum quantity of a vaping product that a pharmacist can supply to a patient in a single transaction?

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

One month if not prescribed, and, if prescribed, the prescribed amount.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Given the range of products, nicotine strengths and consumer usage patterns, how is a pharmacist supposed to objectively determine what constitutes a month's supply?

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

Well, you know, I think what we're asking here is: how well trained are pharmacists? I think that's almost an insult to the intelligence of pharmacists across the country. They fill prescriptions for lots of medications—hundreds and hundreds of medications—across the country for different treatments, and I'm sure they're more than capable of understanding how much a month of supply is.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Under most prescribing arrangements, the pharmacist would be given information on the quantity of that prescription. For instance, pseudoephedrine has a requirement of the quantity that can be supplied in that period. So I'm just interested to understand what training is going to be in place for pharmacists, particularly when the pharmacy sector have already been very clear that they don't want to do this anyway because they don't believe that it fits in with the role that they play in the community. So, whilst I do absolutely respect the extraordinary professionalism and health knowledge of our pharmacists, we're talking about a completely different thing here. So, once again, I would like to understand: if somebody walks into a pharmacy and they are allowed one month's prescription, what does that entail? How are the pharmacists supposed to be able to meet the legal obligations of supplying a month?

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

I'll just reflect back on my response about the Pharmaceutical Society. My response was that we are working closely. One of those areas where we are working closely obviously is this particular point about the guidance that's required for pharmacies to be able to know what to do in terms of the month prescription.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Minister, I would suggest this is actually the law; it's not professional guidance that we're putting through here. More specifically, is the minister aware of concerns regarding pharmacies' liability or professional indemnity if they supply unregistered products without a prescription?

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

Senator, I think you would know that they would all have indemnity insurance and would be aware, whether it's around vaping or any of the other products that they provide to customers. I'm just trying to work out where you're trying to go with this line of questioning when we know that it is a general practice of pharmacists to be across all of these concerns.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

My specific question was: were you aware of the concerns? So is the government aware of these concerns?

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

I'm advised that there are always issues raised, and this is one that's not new to the government.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

():  What I need to understand is whether the government has itself sought to understand whether existing indemnity and liability insurance is sufficient to cover the requirement of pharmacies to provide and supply these particular products. Has the government been through the process of understanding whether there is any liability that's attached to an insufficiency of professional indemnity insurance to cover the supply of vape products, given the nature of vape products? Has the government sought to satisfy itself that there is no problem?

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

Thank you, Senator. I am certainly advised, and I know that, from your previous role as a minister, you know that when pieces of legislation go through all of these processes are checked through, including indemnity and looking at liability. They are part and parcel of what we try to do in the scrutiny of any piece of legislation that comes before the Senate.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Could the minister point me to the part of the legislation that refers to professional indemnity?

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

It certainly isn't in this piece of legislation. I'm talking about the processes that we go through. You asked: has the government looked into it? My response was in relation to our processes in putting forward a piece of legislation.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

If there is any possibility you might take it on notice to provide me with further advice about what processes you went through in order to satisfy yourself that you weren't requiring a pharmacy to do something that their indemnity didn't cover, I look forward to that. What point-of-sale requirements will pharmacies be required to adhere to in order to legally supply e-cigarette products under state and territory law? While you're at it, could you let us know who, if there are additional compliance costs, will be paying them?

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

Well, if a customer comes in, they go to the counter, Senator—schedule 3, via the counter. I'm just trying to understand what your questioning is, when we're talking about pharmacies having the ability to do this. I'm not sure if I've misunderstood your question; please correct me if I have.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I'm keen to understand what the physical requirements of the pharmacy are in terms of point of sale. For instance, if e-cigarettes can't be stored where they're visible to the public—often they need to be stored in lockable cupboards or whatever—are there any point-of-sale requirements that are specific to the sale of vapes?

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

Thank you, Senator, for clarifying. It would be behind the counter. It's not something that a customer would walk in and be able to pull off the shelves.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

So there would be nothing to stop a pharmacist from having a pile of vapes right next to the baby Panadol behind the counter, for instance, which also requires over-the-counter access?

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

Senator, at some point we need to be able to trust the pharmacies to use their discretion, I would imagine.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I'm not sure the pharmacies want to use their discretion, which, I think, is the point I'm trying to make. Under which states is it a mandatory requirement for pharmacists to record a schedule 3 pharmacist medicine, which includes personal details of the person purchasing it?

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

Thank you for the question. I will take that on notice. I am advised that, with the discrepancy between the states and territories, it will be different, so I'm happy to take that question on notice.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

You may not be able to answer this because it actually came from the press release of the Greens. It was really clear in the Greens' press release that the agreement reached between the Greens and the government was that, when somebody purchased vaping products through a pharmacy under this particular mechanism, their details, including their name, would not be recorded. I accept that you've taken my question on notice. Right now, under Queensland law, as an example, a pharmacist must attach a label to a schedule 3 medication—a label that includes the details of the person that is purchasing it—and the pharmacist is required to keep that information for two years. I'm interested to understand the inconsistency between the announcement that personal details would not need to be recorded and the fact that, under Queensland law, they are required to be recorded.

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

Thank you, Senator. I can certainly take that question on notice.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Is the minister aware that several of the big-banner pharmacies, with hundreds and hundreds of pharmacies under those banners, have indicated they will not stock vaping products in their pharmacies?

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

We are aware that there are pharmacies that already have chosen not to do that. We've already seen that there are thousands across the country who do adhere to this, so we are conscious of the fact that there will be some that won't stock vaping products.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

In the use of the word 'some', one would presume you're not thinking it's going to be terribly many. Do you have any indication at all of how many pharmacies are likely to not stock these products? Has any work been done to understand that?

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

I'm advised that we are leaving it entirely up to the pharmacy sector.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Are there any other examples that the minister might be able to point to where unregistered products can be supplied without a prescription?

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

I'm advised the answer is no, there are not.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Just to be clear: are you advising me that there are no other examples of unregistered products that can be supplied without a prescription or are you advising me that you're not aware of any?

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

That has slightly changed again, so I will take that question on notice, Senator. I was referring to your initial question.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Just to be clear, I'll read the previous question that I asked: can the minister provide other examples where an unregistered product can be supplied without a prescription? That was my first question, and you said no to that. Basically you're saying that you can't provide other examples; you're not suggesting that there aren't other examples. You just don't have any?

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

That's correct.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

To that end, would it be possible to provide on notice to this chamber any other examples that do exist? I quite understand that you probably don't have them in your back pocket, but could you seek that from the department and, in the shortest possible time, provide us with a list of unregistered products that can be supplied without a prescription?

The Pharmaceutical Society of Australia President Fei Sim has said publicly that these amendments undermine the role of pharmacists as healthcare professionals. Minister, have you heard that?

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

No, I haven't heard that.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Do you agree with that?

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

As I've said here this morning, we are leaving it to pharmacies to use their discretion as to whether they wish to go down this path in adhering to the laws that we'd like to pass here for the general safety and wellbeing of our children across Australia. Clearly there will always be different points of view, but I would encourage pharmacists who are listening across the country, to please get on board and assist our government to go ahead with this world-leading piece of legislation that will make a difference to the lives of families across our country.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Minister, if this legislation is world leading, as you've just said, why is the government waiting three years for it to be reviewed? Will the government support the opposition in having a review in one year to see how amazingly world leading it really is?

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

Senator, I love your support for what we're trying to; it's clearly on show for all of us to see. What we will need to do over the next couple of years is, obviously, get data. Then we will be able to understand the usage—what's happening with the pharmacies, our schools and our children in relation to the sales of vapes—and understand what kind of data we will need to then be able to have a very thorough review.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I think there is one thing on which everybody in this chamber, in this parliament and across the whole of Australia agrees, and that is that we don't want people, particularly children, to get access to vapes. Most particularly, we do not want a thriving black market to continue, which is what we know that we have under the current arrangements. To this end, Minister, could you advise where the Illicit Tobacco and E-cigarette Commissioner is and when they are due to commence their role? That was a previous commitment of your government about six months ago under previous legislation.

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

Thank you, Senator, for your interest. I am advised that the commissioner will be announced shortly.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I look forward to that. If pharmacists refuse to stock these vapes, has the government assessed what impact that is likely to have in terms of pushing Australians towards an illicit black market?

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

Well, as I've said, clearly pharmacies will have the discretion as to whether they support this—and I certainly hope they do—and how they will go about it. We are very aware of the concerns around the black market. To deal with that issue and the possibilities that it could impact we've provided funding, resourcing, of an additional $25 million to the Australian Border Force and $56.9 million to the TGA over two years. We don't go into this thinking there will be no black market. We recognise that we have to deal with the realities here. So, that's our way of ensuring the enforcement around that, and we sincerely hope we can see the details through this over the next couple of years.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Is it the government's view that vapes are medicine?

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

This is one of your 'gotcha' moments, isn't it, Senator? I mean, they were initially sold as therapeutic goods, and we know that, and there's still evidence emerging as to what's going on in the longer term. So, that's my response to that.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

Okay. I'm just interested that you would be asking a pharmacist not to sell a medicine.

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

Not to sell it?

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

To sell something that isn't a medicine. That's why I asked whether you believe vapes are medicinal. I want to circle back in relation to—

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

Sorry, Senator: I missed that last question. I was just getting some advice. Obviously under the framework that you had previously set up, is my understanding—around the therapeutic goods side of vaping. But we do know that evidence is still emerging into the long term with it. And you asked another question just now?

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

No, I stopped halfway through it.

But circling back, I'm really interested to understand how much thought has been put into the logistics of applying this policy in practical terms in a pharmacy. It's my understanding that e-cigarette products must not be visible to the public from anywhere inside or outside a retail shop. You can temporarily open a storage unit if a customer asks for a specified e-cigarette. What are the provisions, the discussions with pharmacy, around making sure they have these particular storage units? I understand we're going to stay with the prescription-only model until October. But, as of October, who will be required to pay for these? And what consideration or consultation has been undertaken with pharmacies as to how they are physically supposed to be locating these? Also, could I seek some confirmation—previously you said it would be up to the discretion of the pharmacist as to how they stocked and displayed vapes in their store, yet it seems quite clear from this that pharmacies, or anyone, have a requirement for them to not be visible to the public.

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

I just want to be clear, though, about when I talked about the discretion of the pharmacist. You gave an example of vapes being next to the baby Panadol. So, I was using the word 'discretion' in terms of examples like that, where I think a pharmacist would know where they should put the vapes—maybe not next to the baby Panadol. So I want to be clear on that point, if I can, given the example you provided in the question.

The pharmacist will have access to clinical guidance and resources which offer alternative smoking cessation methods to patients. The goods will only be available behind the pharmacy counter, and individuals will be required to provide ID to the pharmacist. Limitations will be placed on the concentration of nicotine available, and the model will not be available to under-18s, who can only access these goods with a prescription from a doctor. I think they're really quite straightforward guidelines, but, as I said in one of my earlier answers, we are continuing to work closely with the Pharmaceutical Society in terms of the rolling out of all this. I'd bring you back to that, Senator.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I'm interested in why the government would be working with the Pharmaceutical Society around the legal requirements of a pharmacy. The Pharmacy Guild is the representative body of the people who own pharmacies. The people who own pharmacies are the ones who are going to have to put these provisions in in terms of point of sale. So I'm interested to know why the government would be consulting the Pharmaceutical Society of Australia on something which is clearly the jurisdiction of the Pharmacy Guild.

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

Please don't misinterpret the fact that I've said we're working closely with the Pharmaceutical Society to mean that we're not working closely with anyone else. I said at the outset that we've engaged in conversations right from the get-go in terms of wanting to see this legislation come to fruition. That means working with the Pharmacy Guild. It means working with the pharmacies across Australia, the pharmacy sector, the AMA and the medical sector. These are ongoing conversations. For the clarity of the Senate, I want to make it very clear that the minister continues to work with all of those areas in the medical fraternity.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I want to circle back to the legal requirements. We've got an example from Queensland about having to record names and stick people's names on products for schedule 3 medicines. The Victorian government, as I've just pointed out, requires e-cigarettes to not be visible and to be stored in lockable containers. There's almost a juxtaposition. You're saying, 'We respect the discretion of the pharmacies and their professional health authorities,' and I absolutely think our pharmacists are fabulous, but they have legal requirements. They are the laws of the states and territories of Australia. They have a legal requirement to comply with the laws of those states. Yet you are not giving me any response.

So we have to have non-visible, lockable containers in which vapes must be stored and the only time they can be opened is to actually get the vape out and sell it to the customer. Who is going to be the one responsible for these particular storage units? Who is going to pay for them? What discussions have been had with the pharmacy owners—not pharmacists but the pharmacy owners—about actually doing something? It's but one of the practical implications that exist around dropping a policy like this on the sector at the very last minute. I would reiterate that we're talking about 6,000 largely small businesses around Australia who are the front line of primary care in this country. You and I both come from rural, regional and remote Australia, and we both know they're often the only health professional in town. Who's been working with these people to understand what the consequences of this are, and who is going to pay?

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

There's quite a lot in your statement there. First I would like to remind the Senate that this is a collaborative arrangement. I said earlier that every chief health officer across the country has supported this. We are supported by each jurisdiction, and it will be up to each jurisdiction to work with the pharmacies in those areas. Clearly the 6,000 pharmacies that we know are across the country will need the support and assistance of the departments of health right across each and every state and territory jurisdiction. So there is a body of work that has to go through in terms of that coordination.

Coming to your last bit in terms of direct contact with each of the pharmacies: of course I'm acutely aware of our regional pharmacies. I've had to work very closely with the ones in the Northern Territory with many of the pieces of legislation and different policies that we've taken through, which thankfully have been very embraced in terms of many of the things that we're doing in the pharmaceutical sector.

I would remind the Senate that this is not something that has just happened overnight; it's not something that just happen in the last month. Our government has said, from the moment that we came into office, that tackling vaping in this country was going to be critical, and we continue to work with the states and territories and the pharmacies across the country to ensure that this legislation does work and is effective.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

What is the measure of that success?

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

Well, I guess I'd certainly like to see that our young people are no longer vaping. I think that's probably the most obvious response to that—if families can feel that their kids are no longer addicted, that they're no longer vaping in places they shouldn't be and they're no longer using it. Okay, that's a very anecdotal and personal response, but I think it's still a very relevant one. This impacts families across the country, and it impacts teachers trying to work with their students.

The legislation commits us to undertaking an independent review of the bill and associated instruments within three years. That's how we will measure. In addition, the government is using a range of resources and data to monitor the impacts of the vaping reforms over the short and longer term. It's important to note these reforms include a series of different regulatory activities, many of which are yet to be implemented, and these reforms are part of a broader suite of regulatory and non-regulatory measures being implemented by all Australian governments to reduce rates of vaping and smoking. We have commenced work with states and territories and other key partners to develop an evaluation program, including outcome indicators to monitor progress—and the work of the states and territories is absolutely critical to the success of these reforms—and the development of nationally agreed monitoring and evaluation activities, including agreed measures of success.

Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

I look forward to seeing the metrics of success. In your previous contribution you said, 'This hasn't just happened overnight.' What has happened overnight is the change in position in relation to the mechanism for supplying vapes in Australia. That has happened in the last few days. Up until Monday Australians were unaware that vapes will be available in pharmacies, without a prescription, if the legislation gets through this place, so I would say that this has happened overnight. It has happened overnight because, for some reason, the government decided that they wanted to do a deal with the Greens. I don't know why the government decided that they needed to change their position. I have to say: the government has been absolutely rock-solid in its obsession with sticking with the prescription-only model, up until a few days ago.

The coalition has always taken the view that restricting and prohibiting children's access to vapes is the No. 1 priority that should be delivered through legislation in this parliament, and we do not shy away from that. We merely differ in our belief about how that is best achieved. At the end of the day, the coalition believes in being honest with the Australian public, and the mechanism through which vapes are currently available is plainly not working. It is not stopping children from getting access to vapes. I don't think there is anybody in this place that doesn't believe that if they walked out of here, no matter how old they were, they could walk into a store somewhere in Canberra and buy a vape. That has been no different over recent times, and following this legislation it will still be no different.

What we question is the need for you to have gone and done a deal with the Greens under the cloak of darkness, without any consultation with he very people it's going to impact—the very people you expect to implement this change of policy: Australia's 6,000 small-business pharmacies around the nation. I think it is not correct to put on the record that this hasn't happened overnight. The change has happened overnight. I will absolutely concede that the government has been pursuing a prescription-only model since it came into government. It had not been pursuing a pharmacy dispensed model until Monday. Or they may have been pursuing that, but the public was unaware of it and the very people who have to put it in place were unaware of it until Monday.

I would say that what we have before us here is one of the most confusing deals I have ever seen, the need for which I have yet to see. We have a completely unworkable solution now being put on the table. We have a whole heap of our frontline health professionals, our primary healthcare workers, our pharmacists, not wanting to have anything to do with this particular change in plan, and yet the government sit here and somehow pretend that they have been consulting with Australia's pharmacists about this particular change.

It is very disappointing that we are sitting here today. We are going to see a messed up change. It is just creating great confusion across the country. There is no consistency in what's gone on here, and yet the government seems to think that it's okay to do some deal with the Greens at the last minute and confuse all of Australia. It's very disappointing, Minister, that in all of the conversations that we've had this morning we don't seem to have got any understanding about the practical implications of a last-minute policy change for one of the most important parts of our health system and a part of our health system that is under immense pressure. We all know that primary care is under immense pressure at the moment. Now we've just turned around and blindsided pharmacies once again. This is a track record of this government. They did it last year when they decided without any consultation that they were going to bring in double dispensing. We've seen the result of that particular action. It has hardly delivered any real benefits in terms of the cost of medicines to Australians.

Here we are, once again, having a debate about something that has been a knee-jerk policy decision of the government under the cloak of darkness without any consultation with the sector that is now required to implement it and no consideration of the costs. We have heard nothing in response to any of our questions about what the government's intentions are in terms of the additional cost burden on our pharmacies of implementing this policy. So it is very, very disappointing to be standing here. We will certainly not be supporting the amendment that they have put forward.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

There's a question that I have to put to the minister. Before I do, I just want to clear up a couple of things at least from the Greens perspective and as a member of the committee which conducted the inquiry into the bill. The Greens were very supportive of the bill going to inquiry so that the committee had the opportunity to give feedback on the bill. One of the processes that we as a committee go through is identifying the witnesses that we believe need to be called to give evidence before the inquiry to enable the various ramifications of the legislation to be fully understood. When we sent out our list of invites for witnesses to give evidence to the committee, the Pharmacy Guild of Australia was on that list. They as an organisation then formally declined to give evidence to the committee. Their declining to give evidence came back to us as committee members and I prioritised a further request to the guild that they give evidence to the committee precisely because I wanted to ensure that the views of the guild in relation to the bill or any proposed changes to the bill were clearly understood and that they had the opportunity to give their views on this legislation. They did not take that opportunity.

So, in my role as health spokesperson for the Greens, I took a meeting with the guild as to their view on the legislation. In that meeting, they articulated that their preferred approach to this area of policy was not to have vaping products listed under schedule 3, which is a perfectly legitimate position for them to put to us in their capacity as a peak body. What I cannot cop and what I must use this opportunity to call out is the argument that the opposition of the guild to schedule 3 is based around a concern that the substances may not be appropriate for use under schedule 3 because they, in the view of the guild, are not safe. Let me say very clearly: the view the guild put to me and my team in our meeting was that they would support schedule 4 of these substances or they would support schedule 2 of these substances. They did not support schedule 3. So to come into this debate and propose that they oppose this scheduling because they are concerned about the safety of the substance is very disingenuous, given that schedule 2 would have made it easier for young people and adults to access vaping products. It would have made them an 'in front of the counter' substance without the requirement to engage in a therapeutic conversation with the pharmacist or to demonstrate proof of age. There's a lot that I will cop in this debate, but I will not cop that perspective from the guild, and I think they need to be more transparent with the Australian public in relation to this debate.

I also want to put on the record that we sit here today about to pass one of the most significant public policy reforms of this parliament. It is historic, what we are about to do. We are about to establish a world-leading scheme to tackle a serious area of public health concern, and I pay tribute to my incredible team, who through the course of this legislative debate, through the course of our consideration of the government's proposal, have demonstrated the most incredible capacity to engage with a complex policy area, to negotiate among many varied perspectives, to bring the community into the conversation and to ensure that the legislation's details were fully understood and known. I thank them for their incredible dedication and work in this area. I specifically acknowledge that this has taken a lot of time—as it should, commensurate with its importance—but I think it is really vital, as we get to this moment today, to acknowledge that, while the people officially on the other side of the golden bar, you would hope, played a role in getting the legislation to where it is, there are whole teams of people who have also given up their weekends, their evenings and their days off to get this to where it is today. We as MPs have a responsibility to ensure that the public has a clear view that what we contribute to these spaces is the product of the team's collective work.

Now I shall get to my question for the minister. Minister, under this legislation, what does the government expect will be the threshold of reasonable suspicion a police officer will have to meet to conduct a search of a person?

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

Thank you, Senator, for your question. Search-and-seizure powers are not given under the TGA act, and this is a matter for the states and territories. Our amendments strengthen the bill and ensure individuals will not be criminalised. The government has been clear since we began undertaking our vaping reforms that we are not setting out to punish or criminalise individuals who use vapes. We have, rightly, always treated vaping as a public health issue first, and the bill and its explanatory memorandum make this clear, indicating that offence provisions are not intended to be used against individuals but rather against commercial actors.

The government's amendments to the offence provisions—which we have developed with your party, Senator Steele-John—after the application of the offence set out under proposed section 41QD of the bill. This offence will now apply to retailers in a retail setting who possess less than a commercial quantity of vaping goods, ensuring that the offence specifically targets commercial actors. Similarly, the offence set out under proposed section 41QC—possession of greater than a commercial quantity of vaping goods—now includes an exemption for individuals who hold up to five times a commercial quantity of vaping goods, provided they are for their personal use and were legally supplied.

The government has also been working closely over the past year with state and territory governments, their health departments and their police forces to carefully design an enforcement framework, which again makes clear that individuals are not to be targeted in the application of these laws.

I thank you, Senator, for raising this very important question. It goes to the core of the intention of these reforms, and I'm pleased we have been able to work together to ensure that the bill more closely reflects our intentions in this regard.

David Pocock (ACT, Independent) Share this | Link to this | Hansard source

Minister, I have a couple of questions on how this policy will be evaluated, but, firstly, I would like to say—Senator Ruston was making this point—that this bill has changed substantially over the last week. We're essentially considering a vastly different bill to the one that was on the table last week, and it's disappointing that stakeholders weren't given more time to consider these changes.

Since the details of the bill were released earlier this week, the overwhelming message I've received directly from medical professionals and public health experts is that this is not ideal. As was mentioned, the Pharmacy Guild don't appear to support these changes, despite being the ones who will be the most impacted through this new model. I wonder if, at any time, the Greens asked the pharmacy profession, the medical profession or the public health community how they felt about what was being proposed and what emerged earlier this week on the new model that's on the table.

I don't disagree with many of the changes that have been made, but I know that legislation is strongest when there is rigorous debate, scrutiny and buy-in from those who need to implement it. Clearly, leaving the current policy settings in place isn't an option. The current system, which was put in place by the former government, has undermined our public health. It's been a public health disaster. It's led to an explosion of underage vape use and illegal sales and has created a new generation of nicotine addicts in Australia.

The alternatives we are offered today are to do nothing and continue with the current model, which is not working, or to wait for the coalition to develop a policy on retail sale. Let's be clear: a retail model will develop a new generation of full-time vapers, leading to full-time smokers. I think it's an appalling way forward. We know that tobacco use causes lung cancer, which is still the leading cause of cancer death in this country, despite all the work that has gone into reducing smoking. At the same time, tobacco increases the risk of stomach cancer, throat cancer, liver cancer, pancreatic cancer, cervical cancer, colon cancer and bladder cancer. It also causes heart disease, stroke, cardiovascular disease and type 2 diabetes. It suppresses your immune system. It can contribute to hearing loss. There's excellent research showing that vape use puts young people on a path to tobacco use; you can't separate the two. I don't think any parent wants vaping or tobacco for their child.

It took the world a long time to grapple with tobacco—it took decades—and we saw lots of delaying tactics. Many lives were lost. Most of us will know someone who smoked and ultimately faced the health consequences of that. While vaping leads to tobacco use, we also don't know the long-term impact of vaping. We know only that the chemicals within vapes are harmful. With this in mind and with the options on the table, I will be supporting the amendment and the bill.

It is critical that we do not create a new generation of nicotine addicts. If we can stop it before it starts, we will be saving lives. I would love to see us as a parliament taking this longer-term view on legislation—actually looking up to the young people who are coming through this building and getting a view on democracy that is meant to represent them. But so often we're so focused on the next election that we're not willing to do the hard things to protect them. When it comes to things like climate change and having a duty of care to young people, as well as housing and actually addressing some of the root causes of the housing crisis, we've got to be looking longer term.

Minister—going back to my initial point—I would like to know how the government will be evaluating the success of this model. What is laid out and what are the timeframes for review?

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

Can I take this opportunity to thank you and Senator Jacqui Lambie for your collaboration on this bill. I know that tremendous effort has gone into getting the legislation to where it is and I certainly hear your thoughts there in your statement. There's been lots of data collected and reported already, by AIHW and ABS, as you would know, and what I've said previously in committee is that the legislation commits us to undertake an independent review of the bill and associated instruments within three years. The reason for that is that we need to be able to collate data over that period of time. You're right, election cycles have a habit of interfering with all sorts of things. That's just me throwing that in, but I am conscious that that timeframe is important. I also want to reassure the Senate and the parliament that that independent review will take place as part of this piece of legislation.

The government is using a range of resources and data to monitor the impacts of the vaping reforms over the short and longer term. It's important to note that these reforms include a series of different regulatory activities, many of which are yet to be implemented, and that these reforms are part of a broader suite of regulatory and non-regulatory measures that are being implemented by all Australian governments to reduce rates of vaping and smoking. Clearly, the support of our state and territory counterparts is absolutely essential to ensure that this legislation is successful right across the country. We can't do this on our own, and that requirement of the states and territories is going to be critical, especially in the coming months as the minister meets with the respective health ministers of each state and territory jurisdiction.

We've certainly commenced work with the states and territories and other key partners to develop an evaluation program that includes outcome indicators to monitor progress. The work, as I said, of the states and territories is absolutely critical. We want to work to end recreational vaping. We need to ensure that those hardened smokers who really need a therapeutic vape to help them quit can get one. Most smokers quit without any nicotine replacement tools, but if a hardened smoker finds the resolve to walk into their local pharmacy and say, 'I want to quit,' then we want that pharmacist to have a conversation with them, then and there, and be able to offer the gum, patches or therapeutic vape that might help that smoker give up for good without having to refer them to a GP appointment that might be several days or weeks later, when their resolve might have waned.

Pharmacies will only stock therapeutic vapes without the candy flavours, brightly coloured packaging or sky-high nicotine concentrations. We think that 1 October is an appropriate date for this improved access to take effect. It will allow time for the rigorous systems, protections and oversights to be established, while also ensuring that access is improved before March next year, when the price of tobacco products will rise and a whole range of new smoking protections will see new graphic warnings and changes to the look of cigarettes, tobacco products and packs to make them more dissuasive and less appealing.

Additionally, we think this measure will have a particularly positive impact for consumers in rural and remote areas, who find accessing a general practice a barrier to seeking clinical care. I say to all Australians and those involved in this piece of legislation: thank you for the work that you've done to enable us to put this before the House and before the Senate. It is, as many senators have said, world-leading legislation. I thank all senators for their involvement.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

The time for consideration of the bill has expired. After I have put the question before the chair, I will then put the questions on the remaining stages of the bill. The question before the chair is that the opposition amendment on sheet 2681 to government amendment (5) be agreed to.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

The next questions relate to the amendments moved by Senator McCarthy on sheet ZC286. So, the first question is that amendments (1) to (10) and (12) to (27) on sheet ZC286, moved by Senator McCarthy, be agreed to.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

We now come to amendment 11. The question now is that section 42DZ in item 27 of schedule 1 standard as printed.

Government opposed section 42DZ in item 27 of schedule 1 in the following terms

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

Question negatived.

The question now is that the opposition amendments on sheets 2586 and 2587 be agreed to.

Opposition amendments—

SHEET 2586

(1) Schedule 1, item 11, page 21 (line 13), omit "or subsection (9)".

(2) Schedule 1, item 11, page 21 (after line 14), after subsection 41QD(6), insert:

Evidential burden of proof

(6A) Despite subsection 13.3(3) of the Criminal Code and section 41QE of this Act a person does not bear an evidential burden in relation to the matters in subsection (9).

_____

SHEET 2587

(1) Schedule 1, item 11, page 26 (after line 17), insert:

Division 3 — Periodic reporting by Minister

41RE Periodic report on smoking and vaping rates

(1) As soon as practicable after the end of each reporting period, the Minister must cause a report to be prepared on smoking and vaping rates in Australia.

(2) As soon as practicable after the completion of a report, the persons who prepared the report must give the report to the Minister.

(3) The Minister must cause each 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.

(4) The Minister must be satisfied that each report was prepared in collaboration with such Commonwealth, State and Territory agencies as the Minister considers appropriate.

(5) In this section:

reporting period means:

(a) the period of 6 months beginning on the day this section commences; or

(b) each subsequent 6-month period.

Note: The Illicit Tobacco and E-cigarette Commissioner must prepare reports on enforcement statistics, and analysis of those statistics, relating to the illicit tobacco and e-cigarette trade in Australia, including detections and seizures of illicit tobacco and e-cigarette products, and associated arrests. Reports must be prepared every 12 months and tabled in both Houses of the Parliament. See Chapter 6A of the Public Health (Tobacco and Other Products) Act 2023.

Andrew McLachlan (SA, Deputy-President) Share this | Link to this | Hansard source

I will now deal with the amendments circulated by Pauline Hanson's One Nation on sheet 2668. The first question is that certain components of the bill stand as printed. The components to stand as printed are: in item 11 of schedule 1, subsections 41Q(2), 41QA(2), 41QB(2), 41QC(3), 41QC(6), 41QC(9), 41QD(3) and 41RD(3) and division 2 of part 4A-2; in item 27 of schedule 1, subsections 42DZD(2), 42DZG(2), 42DZG(4) and 42DZL(3); and, in item 111 of schedule 1, subsection 41MN(9B).

Pauline Hanson's One Nation opposed schedule 1 in the following terms—

(1) Schedule 1, item 11, page 9 (lines 23 to 25), subsection 41Q(2) to be opposed.

(4) Schedule 1, item 11, page 10 (lines 22 to 25), subsection 41QA(2) to be opposed.

(7) Schedule 1, item 11, page 12 (lines 1 to 3), subsection 41QB(2) to be opposed.

(10) Schedule 1, item 11, page 16 (lines 20 to 26), subsection 41QC(3) to be opposed.

(11) Schedule 1, item 11, page 17 (lines 8 to 14), subsection 41QC(6) to be opposed.

(12) Schedule 1, item 11, page 17 (lines 25 to 30), subsection 41QC(9) to be opposed.

(15) Schedule 1, item 11, page 20 (lines 15 to 20), subsection 41QD(3) to be opposed.

(18) Schedule 1, item 11, page 23 (line 4 to 11), Division 2 to be opposed.

(19) Schedule 1, item 11, page 26 (lines 5 to 9), subsection 41RD(3) to be opposed.

(21) Schedule 1, item 27, page 32 (lines 13 to 28), subsection 42DZD(2) to be opposed.

(24) Schedule 1, item 27, page 35 (lines 9 to 13), subsection 42DZG(2) to be opposed.

(25) Schedule 1, item 27, page 35 (lines 23 to 30), subsection 42DZG(4) to be opposed.

(27) Schedule 1, item 27, page 39 (lines 21 to 27), subsection 42DZL(3) to be opposed.

(33) Schedule 1, item 111, page 64 (lines 18 to 28), subsection 41MN(9B) to be opposed.

Question agreed to.

We now come to the remaining question, and that is that the remaining amendments on sheet 2668 be agreed to.

Pauline Hanson's One Nation's ci rculated amendments—

(2) Schedule 1, item 11, page 10 (lines 11 to 13), omit the note.

(3) Schedule 1, item 11, page 10 (after line 13), at the end of section 41Q, add:

Evidential burden of proof

(6) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to the matter in subsection (5).

(5) Schedule 1, item 11, page 11 (lines 23 to 25), omit the note.

(6) Schedule 1, item 11, page 11 (after line 25), at the end of section 41QA, add:

Evidential burden of proof

(6) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to the matter in subsection (5).

(8) Schedule 1, item 11, page 12 (lines 20 to 22), omit the note.

(9) Schedule 1, item 11, page 12 (after line 22), after subsection 41QB(5), insert:

Evidential burden of proof

(5A) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to the matters in subsections (6), (7) and (8) or subsections (9), (10) and (11).

(13) Schedule 1, item 11, page 18 (lines 19 to 21), omit the note.

(14) Schedule 1, item 11, page 18 (after line 21), after subsection 41QC(12), insert:

Evidential burden of proof

(12A) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to the matters in subsections (13) and (14).

(16) Schedule 1, item 11, page 21 (lines 12 to 14), omit the note.

(17) Schedule 1, item 11, page 21 (after line 14), after subsection 41QD(6), insert:

Evidential burden of proof

(6A) Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to the matters in subsections (7) and (8) or subsection (9).

(20) Schedule 1, item 11, page 26 (line 21), omit "or (2)".

(22) Schedule 1, item 27, page 32 (line 30), omit "or (2)".

(23) Schedule 1, item 27, page 33 (line 2), omit "or (2)".

(26) Schedule 1, item 27, page 36 (line 26), omit "or (4)".

(28) Schedule 1, item 102, page 61 (line 29) to page 62 (line 11), omit the item, substitute:

102 Subsection 22(7AA)

Repeal the subsection.

(29) Schedule 1, item 107, page 63 (lines 3 and 4), omit ", (9A) and (9B)", substitute "and (9A)".

(30) Schedule 1, item 108, page 63 (lines 6 and 7), omit ", (9A) and (9B)", substitute "and (9A)".

(31) Schedule 1, item 109, page 63 (lines 9 and 10), omit ", (9A) and (9B)", substitute "and (9A)".

(32) Schedule 1, item 110, page 63 (lines 12 and 13), omit ", (9A) and (9B)", substitute "and (9A)".

Question negatived.

Pursuant to order, I shall report the bill.

Bill reported with amendments; report adopted.