National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2023 (No. 9)

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Pharmaceutical benefits—early supply)
Amendment Instrument 2023 (No. 9)

PB 113 of 2023

Purpose

The purpose of the National Health (Pharmaceutical benefits—early supply) Amendment Instrument 2023 (No. 9) (Instrument) is to amend the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015) (Principal Instrument).

PB 120 of 2015 specifies the pharmaceutical items that are in pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, and to specify the period following previous supply that is the ‘early supply period’.

The amendments made by this Instrument are a consequence of amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (the Listing Instrument), which commence on the same day. The Listing Instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act. The amendments also increase the early supply period for 88 existing listed PBS drugs from 20 days to 50 days, where the patient was previously prescribed an increased maximum quantity equivalent to 60 days supply.

Authority

Subsection 84AAA(1) of the National Health Act 1953 (Act) provides that a supply of a pharmaceutical benefit (whether or not the supply is of a kind described in paragraph 84C(4A)(a) of the Act) to a person is an early supply of a specified pharmaceutical benefit if:

(a)           The pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection 84AAA(2); and

(b)           the supply is made within 20 days after the day of a previous relevant supply to the person of:

(i)       the same pharmaceutical benefit; or

(ii)     another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit; or

(iii)   another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit; and

(c)           the supply does not result from a prescription originating from a hospital.

Subsection 84AAA(2) of the Act provides that the Minister may specify, by legislative instrument, pharmaceutical items for the purposes of paragraph 84AAA(1)(b) of the Act.

Subsection 84AAA(3) provides that the instrument may specify a pharmaceutical item by reference to the circumstances in which a pharmaceutical benefit that has the pharmaceutical item is supplied or any other circumstances in relation to a pharmaceutical benefit that has the pharmaceutical item.

Paragraph 84C(4A) of the Act refers to repatriation pharmaceutical benefits supplied under the schemes established under section 91 of the Veterans’ Entitlements Act 1986 or section 18 of the Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006 or supplied in accordance with a determination made under paragraph 286(1)(c) of the Military Rehabilitation and Compensation Act 2004.

Subsection 101(3AA) of the Act requires the Pharmaceutical Benefits Advisory Committee (PBAC) to make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2).

Changes to PB 120 of 2015 made by this instrument

The Principal Instrument previously provided for a 20‑day early supply period in respect of all pharmaceutical benefits specified in that instrument. On 1 September 2023 the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 was amended to enable PBS prescriptions to be written for an increased maximum dispensed quantity, equivalent to 60 days’ supply instead of the usual 30 days’ supply. Prescriptions for increased maximum dispensed quantities may only be written for certain pharmaceutical benefits and in certain circumstances, including that the prescription must be written for a patient with a certain chronic stable medical condition.

This Instrument amends the Principal Instrument so that, where the supply is on the basis of a PBS prescription written for an increased maximum dispensed quantity and the patient’s previous relevant supply was also on the basis of a prescription written for an increased 60‑day maximum dispensed quantity supply, the early supply period is extended to 50 days. These amendments include:

• the creation of a new Schedule 2, which specifies the pharmaceutical items subject to a 50‑day early supply period during which PBS safety net entitlements may not apply (affecting 88 existing listed PBS drugs)
• the removal from Schedule 1 of pharmaceutical items subject to a 50‑day early supply period.

Where a patient’s previous relevant supply of one of the 88 listed PBS drugs was not on the basis of a PBS prescription written for an increased maximum dispensed quantity, the early supply period remains 20 days.

The changes made by this instrument also amend Schedule 1 to provide for the deletion of forms of the listed drugs ranitidine and labetalol, and the addition of maximum quantities and numbers of repeats for the listed drug upadacitinib in the list of pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.

These changes are summarised by subject matter in the Attachment.

Variation and revocation

Unless there is an express power to revoke or vary PB 120 of 2015 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 120 of 2015.

Consultation

The involvement of PBAC constitutes a formal and ongoing process of consultation. The PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits. PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. The Committee also includes a pharmaceutical industry nominee. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the Committee. The PBAC has provided advice regarding what should be specified in this Instrument.

This amendment is minor and machinery in nature.

General

A provision-by-provision description of this Instrument is contained in the Attachment.

This Instrument commences on 1 December 2023.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.

ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2023 (No. 9)

Section 1 – Name

This section provides that the name of the instrument is the National Health (Pharmaceutical benefits—early supply) Amendment Instrument 2023 (No. 9) (Instrument) and may also be cited as
PB 113 of 2023.

Section 2 – Commencement

This section provides that the Instrument commences on 1 December 2023.

Section 3 – Authority

This section provides that the Instrument is made under subsection 84AAA(2) of the National Health Act 1953 (Act).

Section 4 – Schedules

This section provides that each instrument specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule, and any other item in a Schedule has effect according to its terms.

Schedule 1 amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (Principal Instrument).

Schedule 1 – Amendments

National Health (Pharmaceutical benefits—early supply) Instrument 2015

Items 1 - 3 – Section 4

Section 4 of the Principal Instrument defines certain terms used in the Principal Instrument.

Item 2 amends section 4 to insert the following definitions:

• purposes code;
• relevant previous supply;
• relevant purpose;
• Schedule equivalent.

A purposes code is defined to have the same meaning as in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Listing Instrument). Purposes codes are used in the Listing Instrument to indicate the purposes for which a maximum quantity or number of units of a pharmaceutical item may be prescribed for PBS supply.

A relevant previous supply means the most recent previous supply to a person of:

• the same pharmaceutical benefit they are being currently supplied; or
• another pharmaceutical benefit that has the same pharmaceutical item as the pharmaceutical benefit they are being currently supplied; or
• another pharmaceutical benefit that is Schedule equivalent to the pharmaceutical benefit.

A relevant purpose, for a pharmaceutical benefit, means a purpose mentioned in Schedule 4 of the Listing Instrument for a purposes code specified in Schedule 1 of that instrument for the pharmaceutical benefit, and which includes the phrase “The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient”. This phrase is included in all purposes that enable the prescribing of an increased maximum quantity or number of units equivalent to 60 days or two months’ supply.

Schedule equivalent is defined to have the same meaning as in Part VII of the Act. A pharmaceutical benefit is Schedule equivalent to another pharmaceutical benefit if the Schedule of Pharmaceutical Benefits states that the first benefit and the second benefit are equivalent.

Item 3 inserts a new subsection 4(2) that provides that a reference to ‘supply on the basis of a prescription’ includes reference to a supply on the basis of a repeat authorisation or deferred supply authorisation.

Item 1 renumbers the existing contents of section 4 of the Principal Instrument as subsection 4(1), as a consequence of the inclusion of new subsection 4(2).

The Listing Instrument is incorporated by reference as in force from time to time, and can be accessed free of charge on the Federal Register of Legislation at www.legislation.gov.au.

Item 4 – Sections 5, 6 and 7

Item 4 repeals and replaces sections 5, 6 and 7 of the Principal Instrument.

Section 5

Subsection 5(1) specifies the pharmaceutical item in the pharmaceutical benefit for the purposes of paragraph 84AAA(1)(a) of the Act if subsection 5(2) or 5(3) of the Instrument applies in relation to the pharmaceutical item.

The specification of a pharmaceutical item for paragraph 84AAA(1)(a) of the Act is required to determine an early supply period for pharmaceutical benefits that have the pharmaceutical item.

Subsection 5(2) applies if the listed drug and the form of the listed drug in the pharmaceutical item are mentioned in Schedule 1 and all the circumstances in section 6 of the Instrument exist in relation to a pharmaceutical benefit that has the listed drug and form in Schedule 1.

Subsection 5(3) applies if the listed drug and the form of the listed drug in the pharmaceutical item are mentioned in Schedule 2 and all the circumstances in section 7 of the Instrument exist in relation to a pharmaceutical benefit that has the listed drug and form in Schedule 2. Where new subsection 5(3) applies, the early supply period will be determined in accordance with subsection 8(3).

The section includes a note telling readers that because all pharmaceutical items have a specified manner of administration for the listed drug and form, the listed drug in that form with that manner of administration is specified.

Section 6

The circumstances specified in section 6 are:

• the form of the pharmaceutical benefit listed in Schedule 1, and the maximum quantity or number of units and maximum number of repeats, are the same as determined under the Act for PBS purposes. These circumstances were included in previous section 6;
• where the supply of the pharmaceutical benefit was made on the basis of a prescription ̶ the quantity or number of units of the pharmaceutical benefit directed to be supplied on any one occasion in the prescription was not directed for a relevant purpose for the pharmaceutical benefit. This circumstance was not included in previous section 6 and is intended to exclude any supplies where the prescription was written for a 60 day supply; and
• any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table in Schedule 1 for a benefit that has the listed drug and form. This circumstance was included in previous section 6. There are no other circumstances currently specified.

Where these circumstances exist in relation to a pharmaceutical benefit that has a listed drug and form mentioned in Schedule 1, the pharmaceutical benefit will have an early supply period. The length of the period is determined under new section 8 of the Instrument.

Section 7

The circumstances specified in section 7 are:

• the form of the pharmaceutical benefit listed in Schedule 2, and the maximum quantity or number of units and maximum number of repeats, are the same as determined under the Act for PBS purposes;
• the pharmaceutical benefit was supplied on the basis of a prescription and the quantity or number of units of the pharmaceutical benefit directed to dispensed was directed for a relevant purpose, in other words a purpose enabling the prescribing of a 60 day supply; and
• any other circumstance for paragraph 84AAA(3)(b) of the Act that is mentioned in the table in Schedule 2 for a benefit that has the listed drug and form. There are no other circumstances currently specified.

Where these circumstances exist in relation to a pharmaceutical benefit that has a listed drug and form mentioned in Schedule 2, the pharmaceutical benefit will have an early supply period. The length of the period is determined under new section 8 of the Instrument.

Section 8

Section 8 specifies the early supply period for the supply of a specified pharmaceutical benefit for the purposes of paragraph 84AAA(1)(b) of the Act.

Subsection 8(2) deals with the early supply period for pharmaceutical benefits that have a listed drug and form mentioned in Schedule 1 and the circumstances for section 6 apply. In that case, the early supply period is the number mentioned under the heading ‘Period’ in Schedule 1. Schedule 1 currently specifies a period of 20 days in all cases.

Subsection 8(3) deals with the early supply period for pharmaceutical benefits that have a listed drug and form mentioned in Schedule 2 and the circumstances for section 7 apply. It provides:

• where the relevant previous supply to the person was on the basis of a prescription, and the quantity or number of units directed to be dispensed was for a relevant purpose for the previously supplied benefit, in other words a purpose enabling the prescribing of a 60 day supply, then the early supply period is the number mentioned under the heading ‘Period’ in Schedule 2. Schedule 2 currently specifies a period of 50 days in all cases;
• in any other case, the early supply period is 20 days. This means that unless the person's immediate previous supply was based on a prescription for the new 60 day supply, a 20 day early supply period will still apply. This will ensure that patients who are first moving to a 60 day prescription from a 30 day prescription are not subject a 50 day early supply period.

Item 5 – Schedule 1 and Schedule 2

Schedule 1 contains the listed drug and the form of the listed drug in a pharmaceutical item which, when the circumstances specified in section 6 apply, will have an early supply period of 20 days.

New Schedule 2 contains the listed drug and the form of the listed drug in a pharmaceutical item which, when the circumstances specified in section 7 apply, will have an early supply period of 50 days. (if the patient’s previous supply was based on a prescription for the new 60 day supply) or, in any other circumstance, 20 days.

As well as amendments that give effect to the extended 50 day early supply period, the amendments in Schedule 1 involve the deletion of forms of listed drugs and the addition of maximum quantities and number of repeats of a listed drug for the list of pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.

These changes are summarised below.

SUMMARY OF CHANGES TO THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS—EARLY SUPPLY) INSTRUMENT 2015 MADE BY THIS INSTRUMENT

Deletion of Listed Drug, Maximum Quantity and Number of Repeats from Schedule 1 and added to Schedule 2 with an amended Period (days)

Forms Deleted - Schedule 1

Addition of Maximum Quantity and Number of Repeats - Schedule 1

Statement of Compatibility with Human Rights

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

National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2023 (No. 9)

(PB 113 of 2023)

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny)
Act 2011.

Overview of the Legislative Instrument

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2023 (No. 9) (the Instrument) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015) (the Principal Instrument), which specifies pharmaceutical benefits that have an ‘early supply’ period for the purposes of section 84AAA of the National Health Act 1953, and the respective benefits’ “early supply” periods (days elapsed since previous supply), for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.

The effect of a pharmaceutical benefit being an early supply is that the patient payment for that prescription does not count towards the PBS safety net threshold, and, if the PBS safety net threshold has been reached and the operation of the PBS safety net would normally allow a concessional or nil contribution for the prescription, the patient payment and the amount paid by the Commonwealth to the pharmacy or other approved supplier revert to pre-PBS safety net amounts.

The Principal Instrument previously provided for a 20 day early supply period in respect of all pharmaceutical benefits that include the pharmaceutical items specified in the Principal Instrument. On 1 September 2023 the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 was amended to enable prescriptions to be written for an increased maximum dispensed quantity, equivalent to 60 days supply instead of the usual 30 days supply. Prescriptions for increased maximum dispensed quantities can only be written for certain pharmaceutical benefits and in certain circumstances, including that the prescription must be written for a patient with certain chronic stable medical conditions.

This Instrument amends the Principal Instrument so that, where the supply is on the basis of a prescription written for an increased maximum dispensed quantity and the patient’s previous relevant supply was also on the basis of a prescription written for an increased 60 days maximum dispensed quantity supply, the early supply period is extended to 50 days. These amendments include:

• The creation of a new Schedule 2 that specifies the pharmaceutical items for which a 50 day early supply period during which PBS safety net entitlements may not apply (88 existing listed PBS drugs); and
• The amendment of entries for those pharmaceutical items in Schedule 1 to remove lines relating to the increased maximum dispensed quantities (MDQs).

Where a patient’s previous relevant supply of the 88 listed PBS drugs was not on the basis of a prescription written for an increased maximum dispensed quantity, the early supply period remains 20 days.

Schedule 1 also provides for the deletion of a form of the listed drugs ranitidine and labetalol, and the addition of maximum quantities and number of repeats for the listed drug upadacitinib for the list of pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.

Human rights implications

This Instrument engages Articles 9 and 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to health and social security.

The Right to Social Security

The right to social security is contained in Article 9 of the International Covenant on Economic Social and Cultural Rights (ICESCR). It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.

The UN Committee on Economic Social and Cultural Rights (the Committee) reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.

The Right to Health

The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The Committee has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.

The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.

Analysis

This Instrument engages the right to health and the right to social security because drugs listed in this Instrument mean that safety net benefits will not apply for resupplies of these medicines when they are obtained earlier than:

• for pharmaceutical benefits specified in Schedule 1 and where the circumstances in section 6 of the Principal Instrument apply - 20 days from the previous supply; and
• for pharmaceutical benefits specified in Schedule 2 and where the circumstances in section 7 of the Principal Instrument apply - 50 days from the previous supply if the previous supply to the person was on the basis of a prescription written for an increased maximum dispensed quantity equivalent to 60 days supply, and 20 days in other circumstances. This means that where a patient is moving to a 60 day prescription for the first time, they are still only subject to a 20 day early supply period.

This limitation is reasonable, necessary and proportionate, as early supply arrangements support the quality use of medicines and responsible use of PBS entitlements as well as discouraging waste and reducing the quantity of unused medicines in the community. The listing of new and innovative medicines relies on using PBS funding responsibly and keeping the PBS sustainable.

The PBS is a benefit scheme which assists with advancement of these human rights by providing patients subsidised access to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

This Instrument also provides for the deletion of a form of the listed drugs ranitidine and labetalol, and the addition of maximum quantities and number of repeats for the listed drug upadacitinib for the list of pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies.

Written advice from PBAC is tabled with the monthly amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. An unmet clinical need would arise when a currently treated patient population would be left without treatment options once a delisting occurs. Alternative treatment options could include using a different: form, strength or drug. The PBAC considered the delisting of the drugs and forms of drugs in the abovementioned instruments, would not result in an unmet clinical need. The delisting of these items will not affect access to the drugs, as affected patients will be able to access alternative medicines through the PBS and the delisting is unlikely to have an effect on the amount patients pay for those drugs, as co-payment amounts are capped, ensuring their rights to social security are maintained From 1 January 2023, these amounts are $30.00 for general patients and $7.30 for concession card holders.

The drug labetalol in the form tablet containing labetalol hydrochloride 200 mg was requested to be delisted from the PBS by the sponsor. The PBAC noted that the 100 mg strength of labetalol tablets will remain listed on the PBS and advised the delisting of this product would not result in an unmet clinical need. This item was available on the Schedule under Supply Only arrangements for a period of 6 months, allowing patients with a pre‑existing valid prescription to access this item pending transition to an alternative treatment option.

The drug ranitidine in the form syrup 150 mg (as hydrochloride) per 10 mL, 300 mL was requested to be delisted from the PBS by the sponsor. The PBAC noted the low number of services in the last financial year and that there are multiple alternatives on the PBS. The PBAC advised the delisting of this product would not result in an unmet clinical need.

Conclusion

This Instrument is compatible with human rights because it advances the protection of human rights.

Nikolai Tsyganov

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care