Senate

Supplementary Explanatory Memorandum

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

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

OUTLINE

The proposed Government amendments would amend the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024 (the Bill).

The amendments respond to queries from the Senate Standing Committee for the Scrutiny of Bills, as well as concerns raised during the Senate Community Affairs Legislation Committee Inquiry on the Bill and separately by individual Senators in their considerations.

Review of operation of amendments

The proposed Government amendments insert a requirement for an independent review of measures introduced by the Bill and associated legislative instruments to commence no later than 1 July 2027.

This requirement addresses the concerns raised in the additional comments from Coalition Senators to the Senate Community Affairs Legislation Committee Inquiry's Report on the Bill, that the Government has no quantifiable measures of success.^[1] This review provides an opportunity for the vaping reforms to be monitored and evaluated. Additionally, conducting such a review is consistent with the advice in the impact analysis on the proposed reforms to the regulation of vapes published on the Office of Impact Analysis website:
www.oia.pmc.gov.au.

Retail possession offence and civil penalty provisions

The proposed Government amendments replace the offence and civil penalty provisions in the Bill for the possession of less than a commercial quantity of vaping goods (proposed section 41QD) with new, more targeted, offence and civil penalty provisions. The new provisions prohibit the possession of less than a commercial quantity of vaping goods by a retailer in retail premises in Australia. The purpose is to target deliberate dealings in small quantities of unlawful vaping goods by retailers. Consumers and individual users are not covered by these prohibitions.

An exception has also been inserted in the offence and civil penalty provisions for the possession of more than a commercial quantity of vaping goods (new section 41QC) if the vaping goods are for personal use. This amendment is to further reinforce that the purpose of the measures is not to penalise individual users.

Consent scheme

The Bill amends proposed a new section 41RC to require the Secretary to comply with decision-making principles (if any) when exercising the power to consent to applications to manufacture, supply or possess vaping goods. The proposed Government amendments would empower the Minister to make a legislative instrument to determine decision-making principles that the Secretary must comply with in making a decision to grant consent. This legislative instrument would be subject to Parliamentary scrutiny and disallowance.

The provision would respond to concerns raised by the Senate Standing Committee for the Scrutiny of Bills about the conferral of a broad discretionary power on the Secretary.

Merits review of enforceable directions

The Bill provides that the Secretary may give directions to a person in prescribed circumstances. The proposed Government amendments specify that a person to whom directions are given may seek merits review of the decision by the Minister and the Administrative Appeals Tribunal. This responds to a query from the Senate Standing Committee for the Scrutiny of Bills about the availability of merits review.

Forfeiture

The proposed Government amendments ensure that the new forfeiture powers apply to vaping goods that were seized under warrant, and are in an authorised person's custody, immediately before commencement of those powers. This will assist with the safe and orderly disposal and destruction of significant numbers of seized unlawful vaping goods.

Advertising provisions

The proposed Government amendments would remove the proposed Ministerial power to make a legislative instrument excluding advertisements to health practitioners, and certain other classes of persons, from the operation of the new advertising controls. This amendment addresses the concerns raised by certain Senators and stakeholders in the Senate Community Affairs Legislation Committee Inquiry about the breadth of the exclusion in light of aggressive marketing practices of certain sponsors.

Offence and civil penalty provisions concerning breach of a condition

The proposed Government amendments would update the penalty regime in the Therapeutic Goods Act 1989 (TG Act) for breach of a relevant condition of exemption, approval or authority to import or supply a medicine or medical device not included in the Australian Register of Therapeutic Goods (Register).

Supply of therapeutic goods by pharmacists with or without prescription

To facilitate greater patient access to therapeutic vaping goods under health practitioner supervision, the proposed Government amendments would down schedule nicotine in therapeutic vaping goods from Schedule 4 (prescription only medicines) to Schedule 3 (pharmacist only medicines) to the current Poisons Standard in specified circumstances with appropriate safeguards.

These amendments would allow a pharmacist to supply certain therapeutic vaping goods to an adult without a prescription from a medical or nurse practitioner provided certain conditions are met, including that the pharmacist provides professional advice to the patient on alternative cessation supports and therapies. The Government amendments would also propose to amend two other instruments to support the down scheduling of nicotine in certain therapeutic vaping goods.

Financial Impact Statement

There are no financial implications arising from these amendments for the Government's budget.

Statement of Compatibility with Human Rights

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

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

These amendments would not alter the effect that the Bill would have on human rights. The amendments, and the Bill, are compatible with human rights.

NOTES ON AMENDMENTS

SCHEDULE 1—AMENDMENT OF THE THERAPEUTIC GOODS ACT 1989

Therapeutic Goods Act 1989

Amendment items s [1] to [4] – Clauses 2 and 3

Amendment items [1], [2] and [3] provide for the commencement of the proposed Government amendments. The amendments relating to the scheduling of nicotine in vaping goods would commence on 1 October 2024. All other Government amendments would commence at the same time as, or immediately after, the existing provisions of the Bill.

Amendment [4] inserts new drafting notes in section 3 to explain the application of subsection 13(5) of the Legislation Act 2003 to provisions in Schedule 4 to the Bill, which amend or modify provisions of legislative instruments made under the Therapeutic Goods Act 1989 (the TG Act).

Amendment item [5] – Clause 4

Amendment item [5] inserts a new section that requires the Minister to cause an independent review to be conducted on the operation of the amendments made by Schedules 1, 3 and 4 to the Bill and any legislative instruments made for the purposes of those amendments.

This review must commence no later than 1 July 2027 and a written report of the review must be provided to the Minister within 6 months after the commencement of the review. A copy of the report must be tabled in each House of Parliament within 15 sitting days of that House after the report is given to the Minister.

Conducting a review of the amendments to the TG Act and associated legislative instruments underpinning the vaping reforms addresses the concerns raised in additional comments from Coalition Senators to the Senate Community Affairs Legislation Committee Inquiry's Report on the Bill that the Government has no quantifiable measures of success. This review provides an opportunity for the vaping reforms to be monitored and evaluated. This amendment is also consistent with the advice in the impact analysis on the proposed reforms to the regulation of vapes, which recommended a monitoring and evaluation program for the vaping reforms.

Amendment item [6] – Schedule 1, item 11, page 7 (line 10)

This amendment to new section 41R clarifies in the simplified outline of the new Chapter 4A of the TG Act that the Secretary, in deciding whether to give a consent to manufacture, supply or possess vaping goods, must comply with the decision-making principles (if any) determined by the Minister in a legislative instrument.

Amendment item [7] – Schedule 1, item 11 page 18 (after line 14)

This amendment inserts a new subsection 41QC(11A), which provides a new exception to the offence and civil penalty provisions set out in section 41QC concerning possessing at least a commercial quantity but less than a relevant quantity of vaping goods.

Subsection 41QC(11A) provides that the offence and civil penalty provisions in subsections 41QC(1), (3), (10) and (11) will not apply in relation to the possession of vaping goods by a person if the vaping goods have been lawfully supplied to the person, the vaping goods are for use by the person personally, and the quantity is less than 5 times the commercial quantity of that kind of vaping goods.

The note to subsection 41QC(11A) provides that the person bears an evidential burden in relation to the matters in subsection (11A), in accordance with section 13.3(3) of the Criminal Code and section 41QE of the TG Act.

This provision reinforces that the purpose of the Bill is to target the commercial dealing of unlawful vaping goods, and not to penalise individual users who possess vaping goods for their personal use. The context and surrounding circumstances in which the vaping goods are possessed will likely be the primary factor that will determine whether this exception is available.

An evidential burden is the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist. Examples of the ways in which a person may will likely (but not necessarily) satisfy the evidential burden include:

•

provision of a receipt or other proof, such as a bank statement, that the person purchased the goods in a pharmacy retail setting. This is because vaping goods will ordinarily only be lawfully supplied from pharmacy retail settings;

•

if the person obtained the vaping goods under the personal importation scheme prior to 1 January 2024—the written authority from the medical practitioner and proof of purchase and importation;

•

if the person obtained vaping goods which did not contain nicotine prior to 1 July 2024 from a retailer in Australia—a receipt or evidence that shows the date and circumstances of the supply.

A person relying on this exception will also need to point to evidence that suggests a reasonable possibility that the goods are for personal use. This might be demonstrated, for example, by a statement in a statutory declaration.

Amendment item [8] – Schedule 1, item 11, page 18 (line 15)

This minor amendment makes the heading before subsection 41QC(12) consistent with the headings before subsections 41QB(5) and 41QD(6).

Amendment item [9] – Schedule 1, item 11, page 20 (line 2) to page 23 (line 3)

This amendment replaces the offence and civil penalty provisions in the Bill for the possession of less than a commercial quantity of vaping goods (section 41QD) with new, more targeted, offence and civil penalty provisions. The new provisions prohibit the possession of less than a commercial quantity of vaping goods by a retailer in retail premises in Australia. The purpose is to target deliberate commercial dealings in small quantities of unlawful vaping goods by retailers, and not to penalise individual users.

To achieve this clarification:

•

the offence and civil penalty provisions in subsections 41QD(1), (3) and (4) provide that the prohibitions only apply to possession by a retailer at retail premises in Australia;

•

'retail premises' is defined in new subsection 41QD(10) as premises:

-

from which goods or services are available for supply (or are supplied) to a consumer (this may include a retail shop, shopping centre, tobacconist, convenience store, milk bar or mobile food cart); or

-

that are used in connection with the supply of goods or services to a consumer (this may include a warehouse next to but separate from a retail shop which is used to supply that retail shop),

whether or not the premises are used wholly or predominantly for that purpose. The definition of retail premises is necessarily broad to capture the array of premises from which vaping goods may be supplied to consumers. An existing definition of 'premises' is contained in subsection 3(1) of the TG Act;

•

a 'retailer in relation to retail premises in Australia' is defined in new subsection 41QD(10) as a person within the following prescribed categories of persons:

-

an owner, lessee or occupier, such as a commercial tenant, of retail premises in Australia;

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a person conducting a business or undertaking at, or in connection or association with, retail premises in Australia. This is intended to capture the broad variety of retail or retail-related activities in Australia;

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a director, officer or agent of a person referred to in either of the above categories;

-

a person performing work in any capacity for, or on behalf of, a person referred to in any of the three above categories at, or in connection or association with, retail premises in Australia;

•

proposed subsection 41QD(9) continues to provide an exception to the application of the offence and civil penalty provisions in section 41QD if the vaping goods are for use by the person personally and the quantity is not more than the permitted quantity of that kind of vaping good;

•

a 'permitted quantity' of a kind of vaping goods is defined in subsection 41QD(10) as the quantity of that kind of vaping goods prescribed by the regulations.

It is necessary and appropriate for the quantity of a kind of vaping goods that would amount to a permitted quantity to be prescribed in the regulations to:

•

ensure flexibility to change the quantity in line with practices of supervising health professionals;

•

ensure the permitted quantity is adaptive to new and emerging design specifications;

•

allow quantities to be amended efficiently, if necessary, in response to illicit trade of vaping goods to ensure that the offence and civil penalty provisions in section 41QD continue to act as a sufficient deterrent; and

•

maintain a workable connection between the permitted quantity of vaping goods and acceptable volumes or quantities of therapeutic vaping goods.

The regulations are subject to Parliamentary scrutiny and disallowance.

Amendment item [10] – Schedule 1, item 11, page 25 (after line 13)

Section 41RC of the Bill proposes to confer a power on the Secretary to consent to the manufacture, possession or supply of vaping goods.

This amendment introduces new subsections 41RC(2A), (2B) and (2C), which would empower the Minister to make a legislative instrument to determine decision-making principles that, if made, the Secretary must comply with in making consent decisions. This legislative instrument would be subject to Parliamentary scrutiny and disallowance.

Amendment items [11] to [15] – Schedule 1, item 27, pages 29 (line 8) to page 30 (line 3), 30 (lines 23 to 28) and 31 (lines 1 to 11, after line 14 and lines 15 to 20)

These amendments propose revising the prohibitions on the advertising of vaping goods in the Bill to address concerns raised by Senators and stakeholders in the Senate Community Affairs Legislation Committee Inquiry about the breadth of potential advertising to healthcare practitioners.

The effect of the proposed amendments is that the advertising of vaping goods would be prohibited unless authorised in a legislative instrument made by the Secretary under new subsection 42DZC(1).

Amendment item [11] would remove the Ministerial power originally proposed in section 42DZ to make a legislative instrument excluding advertisements directed to health practitioners, and certain other classes of persons, from the operation of the new advertising controls.

Amendment item [12] replaces proposed subsections 42DZC(1) and (2), which originally conferred the Secretary with a power to make an administrative decision to authorise specified advertising. New subsection 42DZC(1) provides that 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.

The instrument would specify all the circumstances in which the advertising of vaping goods is permitted. The intention is to permit certain advertising, including limited advertising to health practitioners and other lawful participants in the supply chain. This legislative instrument would be subject to Parliamentary scrutiny and disallowance.

Amendment item [13] is a minor amendment to remove subsection 42DZC(3). The substance of this provision has been incorporated into new subsection 42DZC(5).

Amendment item [14] inserts a new subsection 42DZC(5), which clarifies that conditions in an advertising authorisation may, without limiting the general power in subsection 42DZC(4) to condition an authorisation, relate to the nature of the audience to which the advertising is targeted (for example, healthcare practitioners), the form of the advertising (such as text only), the content of the advertising (such as pricing information only), or representations or information on the labels of vaping goods, the packages in which vaping goods are contained or any material included with the package in which vaping goods are contained (such as requiring warning labels).

Amendment item [15] is consequential to amendment item [12], and removes subsections 42DZC(5) and (6), which would have provided that an authorisation under section 42DZC is not a legislative instrument and would have been required to be published on the website of the Department of Health and Aged Care.

Amendment item [16] – Schedule 1, item 55, page 50 (lines 8 to 12)

This amendment inserts a new item 55, which provides that new Part 6-2A of the TG Act (concerning forfeiture of things seized under warrant) applies in relation to:

(a)

a thing, including vaping goods, seized under a warrant issued under section 50 of the TG Act on or after the commencement of item 55;

(b)

vaping goods seized under a warrant issued under section 50 of the TG Act before the commencement of item 55, if the vaping goods are in the custody of an authorised person, whether or not the same authorised person seized the goods, immediately before commencement.

The intention of paragraph (b) is to clarify that vaping goods, which are being held by an authorised person (for example, by an officer of the Department) immediately before the commencement of Part 6-2A and which were previously seized under warrant, are subject to the new forfeiture powers. This is intended to assist with the safe and orderly disposal and destruction of a significant number of unlawful vaping goods already held by the Department.

Amendment item [17] – Schedule 1, Part 4, page 50 (after line 18)

This amendment specifies that the decision to give enforceable directions under new subsection 42YT(2) is an initial decision within the meaning of subsection 60(1) of the TG Act. This has the effect that the person to whom the directions were given may seek merits review of the decision by the Minister, and subsequent external merits review by the Administrative Appeals Tribunal (however described).

Additionally, this amendment inserts new subsection 60(2E), which makes clear that only a person to whom the directions were given under subsection 42YT(2) is entitled to request merits review. No other person is entitled to seek review by the Minister or subsequent external review by the Administrative Appeals Tribunal (however described).

New subsection 60(2E) is intended to put beyond doubt who is entitled to seek merits review in relation to a subsection 42YT(2) decision. This clarification is not intended to indicate that the right to seek merits review of any other kind of decision within the meaning of 'initial decision' under the TG Act applies to any broader class of persons.

Amendment items [18] to [26] – Schedule 1, items 100, 101A, 102, 106, 111 and 112

Amendment items [18] to [26] clarify that the offence and civil penalty provisions relating to a breach of a condition of an approval or exemption in sections 22, 22AA, 41MN and 41MNA of the TG Act also apply to a breach of a condition of an authority under those provisions.

Amendment item [27] – Page 69 (after line 15)

This amendment adds a new Schedule 4 to the Bill, to down schedule nicotine in therapeutic vaping goods from Schedule 4 to the current Poisons Standard (prescription only medicines) to Schedule 3 to the current Poisons Standard (pharmacy only medicines), in certain circumstances. Certain therapeutic vaping goods containing nicotine would be available from pharmacists without a prescription to persons 18 and over, subject to specified conditions being met. Therapeutic vaping goods containing nicotine would remain Schedule 4 substances, available on prescription from a medical or nurse practitioner, when supplied to persons under 18 and when the Schedule 3 conditions are not met.

Schedule 4 to the Bill proposes amendments to the current Poisons Standard to effect this change. Consequential amendments are also proposed to other instruments made under the TG Act.

Items 1 to 4 of new Schedule 4 substitute references to "Schedule 4" with references to "Schedule 3" in the exceptions to the prohibitions on the supply or possession of vaping goods in sections 41QB, 41QC and 41QD. These amendments are consequential to item 13.

Therapeutic Goods (Medical Devices) Regulations 2002 (MD Regulations)

Item 5 of new Schedule 4 amends the conditions in table item 2.17 in Schedule 4 to the MD Regulations to replace references to Schedule 4 to the current Poisons Standard with references to Schedule 3 to the current Poisons Standard. Item 2.17 of Schedule 4 to the MD Regulations permits certain kinds of unapproved therapeutic vaping goods to be relevantly imported, manufactured or supplied subject to conditions. This change has the effect of amending the conditions to permit supply of these goods in accordance with state and territory laws governing the supply of Schedule 3, rather than Schedule 4, substances.

Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022 (Rules)

There are no therapeutic vaping goods that are included in the Register for smoking cessation or the management of nicotine dependence. To facilitate unapproved therapeutic vaping goods being supplied by a pharmacist, it is necessary for this to be authorised by the TG Act's regulatory framework. These changes to the Rules support the proposed down scheduling of certain nicotine vaping goods by permitting a pharmacist to supply such goods without a prescription in certain circumstances and subject to certain conditions being satisfied.

Item 6 of new Schedule 4 amends paragraph 5A(2)(c) of the Rules to include references to good nursing practice alongside references to good medical practice, to better reflect that both medical practitioners and nurse practitioners are authorised under subsections 5A(1) and (2) to supply unapproved therapeutic vaping goods mentioned in Schedule 1A to the Rules. Item 7 of new Schedule 4 makes similar changes to paragraphs 5A(2)(d) and (e) of the Rules.

Items 8, 9 and 10 of new Schedule 4 amend subsections 5A(3) and (4) of the Rules to clarify their current effect.

Item 11 authorises a pharmacist to supply a therapeutic vaping good mentioned in Schedule 1A to the Rules to a patient without a prescription in specified circumstances equivalent to the restrictions included in Schedule 3 to the current Poisons Standard outlined below in relation to item 13. These are supplemented by additional controls, many of which apply generally under the Special Access Scheme (SAS) Category C pathway to manage the risks to public health and safety relating to the supply of unapproved therapeutic goods that have not been evaluated for quality, safety or efficacy.

The circumstances in which a pharmacist may supply without a prescription from a medical or nurse practitioner under the Rules include where the quantity of the goods does not exceed the quantity reasonably required for a patient's therapeutic use for 1 month and the supply is to a patient who is 18 years of age or over, and conditions specified in new subsections 5A(6) and (7) are satisfied. These conditions include that:

•

the pharmacist informs the patient that the goods do not have general marketing approval;

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the goods are supplied in accordance with good pharmacy practice; and

•

the goods are stored at all times, including during business hours, in a part of the pharmacist's premises which is inaccessible to the public, consistent with equivalent restrictions imposed under state and territory laws.

Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024 (current Poisons Standard)

Items 12 to 16 facilitate access to therapeutic vaping goods containing nicotine as a pharmacist-only medicine under Schedule 3 to the current Poisons Standard, in certain circumstances. A number of controls are included to safeguard patient health and safety, as well as ensuring appropriate health practitioner supervision of the supply of therapeutic vaping goods.

Item 12 of new Schedule 4 is an amendment consequential to item 13. It inserts a reference to Schedule 3 into table item 27 in subsection 49(1) of the current Poisons Standard.

Item 13 of new Schedule 4 introduces a new entry in Schedule 3 to the current Poisons Standard for nicotine. This new entry refers to 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;

(b)

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

(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;

(d)

the pharmacist provides contact details about smoking cessation support services to the patient;

(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.

This new entry for nicotine in Schedule 3 excepts nicotine 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 in tobacco prepared and packed for smoking. Such products are currently unscheduled and this ensures the current position is maintained.

Item 14 of new Schedule 4 replaces the entry for nicotine in Schedule 4 to the current Poisons Standard to simply except nicotine included in Schedule 3 from the entry in Schedule 4. The entry for nicotine in Schedule 4 to the current Poisons Standard otherwise remains unchanged.

Item 15 of new Schedule 4 amends the entry for nicotine in Schedule 7 to the current Poisons Standard to except nicotine included in Schedule 3 from the Schedule 7 entry.

Item 16 of new Schedule 4 is an amendment consequential to item 13, which amends the Index entry for nicotine in the current Poisons Standard to include the new Schedule 3 entry.

Therapeutic Goods Regulations 1990 (TG Regulations)

Item 17 of new Schedule 4 is an amendment consequential to item 13, which amends table item 15 in Schedule 5A to the TG Regulations to replace references to Schedule 4 to the current Poisons Standard with references to Schedule 3. Like item 5, this item amends the exemption that allows certain kinds of unapproved therapeutic vaping goods to be relevantly imported into, manufactured in or supplied in Australia to require those goods to be supplied in accordance with state and territory laws governing the supply of Schedule 3, rather than Schedule 4, substances.

Application and other provisions

New Part 2 of new Schedule 4 provides for application and other provisions.

Item 18 of new Schedule 4 provides that the amendments made by new Schedule 4 apply in relation to the import, manufacture, possession or supply of therapeutic goods on or after the day new Schedule 4 commences.

Item 19 of new Schedule 4 provides that the procedures and requirements for amending the current Poisons Standard that are set out in the TG Act and the TG Regulations do not apply to the amendments made to the current Poisons Standard by new Schedule 4.

Item 20 of new Schedule 4 includes new restrictions on amending the instruments under the TG Act amended by the Schedule.

Subitem (1) provides that a legislative instrument made on or after the commencement of new Schedule 4 that amends or repeals the amendments made by new Schedule 4 must not commence before the end of the disallowance period for the instrument in either House of the Parliament. This does not include the amendments made to the current Poisons Standard by the Bill.

Subitem (2) provides that subitems (3) and (4) apply to a legislative instrument made under paragraph 52D(2)(b) of the TG Act after the commencement of new Schedule 4 and that amends or repeals the amendments to the current Poisons Standard made by new Schedule 4.

Subitem (3) provides that section 42 of the Legislation Act 2003 applies to a legislative instrument to the extent that it amends or repeals the amendments of the current Poisons Standard made by new Schedule 4. The current Poisons Standard is not a disallowable legislative instrument. This amendment has the effect of making some amendments to the current Poisons Standard subject to disallowance but only to the extent that they would amend or repeal the amendments to the current Poisons Standard made by new Schedule 4. Subitem (4) provides that such a legislative instrument must not commence before the end of the period in which it could be disallowed in either House of the Parliament.

Subitem (5) provides that a person must not make an application under subsection 52EAA(1) of the TG Act for an amendment to the entries for nicotine in the current Poisons Standard made by new Schedule 4. Subitem (6) provides that item 20 is repealed at the end of the day the report of the review required by amendment (5) is tabled in both Houses of the Parliament.