National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2019 (No. 11) (PB 94 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L01522 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2019 (No. 11)

PB 94 of 2019

 

Purpose

The purpose of this legislative instrument, made under subsection 84AAA(2) of the National Health Act 1953 (the Act) is to amend the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015) (the Principal Instrument).

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

The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.  The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.

Authority

Subsection 84AAA(1) of the 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 supply is made within 20 days after the day of a previous 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;

whether or not the previous supply is a supply of a kind described in paragraph 84C(4A)(a) of the Act; and

(b)           The pharmaceutical item in the pharmaceutical benefit is specified in an instrument under subsection 84AAA(2); 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 (Treatment) Act 2006 or supplied in accordance with a determination made under paragraph 256(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

Schedule 1 to the Principal Instrument is amended by the addition, deletion and alteration of listed pharmaceutical items and associated periods and circumstances.  These changes are summarised, by subject matter, in the Attachment.

The ‘listed drug’, ‘form’, ‘manner of administration’, ‘maximum quantity or number of units’ and ‘maximum number of repeats’ for a pharmaceutical item are the same as declared and determined under the Act for pharmaceutical benefits that have a pharmaceutical item.  These declarations and determinations are made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Therefore, a supply of a pharmaceutical benefit that has this pharmaceutical item will be an early supply of a specified pharmaceutical benefit providing the requirements of subsection 84AAA(1) are met.

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

This Instrument commences on 1 December 2019.

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 2019 (No. 11)

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 11) and may also be cited as PB 94 of 2019.

Section 2 Commencement

This section provides that the Instrument commences on 1 December 2019.

Section 3 Amendment of National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015)

This section provides that Schedule 1 amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015).

Schedule 1 Amendments

The amendments in Schedule 1 involve additions, deletions and changes to pharmaceutical items listed in Schedule 1 of the Principle Instrument and the associated periods (days) and circumstances.  These changes are summarised below.

 

SUMMARY OF CHANGES

Listed Drugs Added

Dolutegravir with lamivudine

Tablet containing dolutegravir 50 mg (as sodium) with lamivudine 300 mg

Risankizumab

Injection 75 mg in 0.83 mL pre-filled syringe

 

 

Forms Added

Sevelamer

Tablet containing sevelamer carbonate 800 mg

 

 

 

 


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 2019 (No. 11)

(PB 94 of 2019)

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 2019 (No. 11) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 which specifies the pharmaceutical items that are pharmaceutical benefits for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.

Schedule 1 to the Principal Instrument is amended by the addition, deletion and alteration of listed pharmaceutical items and associated periods and circumstances.

Human rights implications

This Legislative Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients 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.

Conclusion

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

 

 

 

 

Thea Daniel

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2019 (No. 11), referred to as PB 94 of 2019, is an amendment made under the National Health Act 1953. This legislative instrument aims to modify the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015), which specifies the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements do not apply for early supplies. Enacted by the Australian Parliament, the purpose of this amendment is to align the Principal Instrument with the amendments made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), ensuring consistency in the regulatory framework concerning pharmaceutical benefits. This amendment reflects the policy objective of maintaining an updated and accurate listing of pharmaceutical items subject to early supply regulations, thereby facilitating effective management of pharmaceutical benefits within the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a critical role in advising the Minister on the specification of pharmaceutical items for early supply, ensuring that the recommendations are evidence-based and aligned with public health needs. The changes involve additions, deletions, and alterations to the listed pharmaceutical items, along with associated periods and circumstances, as detailed in the attachment to the explanatory statement. This legislative instrument is compatible with human rights, particularly the International Covenant on Economic, Social and Cultural Rights, by supporting the progressive realisation of the highest attainable standard of physical and mental health through the provision of accessible and affordable pharmaceutical benefits.

Scope and Application

The National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 11) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015, which specifies the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. The amendments to the 2015 Instrument, which are detailed in Schedule 1, involve additions, deletions, and alterations to listed pharmaceutical items and their associated periods and circumstances. These changes ensure that the supply of certain pharmaceutical items within specific timeframes will not attract PBS Safety Net entitlements. The instrument applies to all entities and individuals involved in the supply of these specified pharmaceutical items within the Commonwealth of Australia. This instrument, made under subsection 84AAA(2) of the National Health Act 1953, ensures that early supplies of certain pharmaceuticals, defined as supplies made within 20 days after a previous supply of the same or equivalent pharmaceutical item, will not qualify for PBS Safety Net benefits. The changes are aligned with amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee. The instrument does not specify any exclusions or exemptions but relies on existing declarations and determinations under the Act for the listed pharmaceutical items. The instrument, which is a legislative instrument for the purposes of the Legislation Act 2003, commences on 1 December 2019.

Key Provisions

The National Health (Pharmaceutical Benefits – early supply) Amendment Instrument 2019 (No. 11) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 (PB 120 of 2015), which outlines the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. Specifically, it updates the list of pharmaceutical items and the associated periods and circumstances that define when a supply qualifies as an early supply (subsection 84AAA(1)). This involves additions, deletions, and alterations to the listed pharmaceutical items in Schedule 1 of the Principal Instrument (subsection 3). The Act imposes obligations on the parties and entities it governs to ensure compliance with the specified conditions for early supply of pharmaceutical benefits. Pharmaceutical suppliers and providers must adhere to the criteria outlined in the amended Instrument to determine when a supply qualifies as an early supply. This includes ensuring that the supply does not result from a prescription originating from a hospital (subsection 84AAA(1)(c)). Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) has a role in recommending which pharmaceutical items should be specified in the Instrument, ensuring that decisions about access to medicines on the PBS are evidence-based (subsection 101(3AA)). Breaches of the provisions in the Instrument may result in consequences under the National Health Act 1953. The Act does not explicitly detail specific offences or penalties for non-compliance with the early supply provisions in the Pharmaceutical Benefits – early supply Instrument. However, general provisions in the National Health Act 1953 may apply, which could include fines or other civil or administrative penalties for non-compliance with health-related regulations. The exact penalties would depend on the specific nature of the breach and other relevant legislative provisions. The amendments made by this Instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which also commenced on 1 December 2019. This ensures consistency and alignment between the listing of pharmaceutical benefits and the conditions for early supply. The involvement of the PBAC ensures a formal and ongoing process of consultation, with members selected from various health-related professions and fields to provide expert advice on the appropriate pharmaceutical benefits to be listed and the conditions for early supply.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Compliance Obligations

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.