National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2015 (No. 10) - specification under subsection 84AAA(2) (PB 110 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01899 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2015 (No. 10) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 110 of 2015

 

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 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by: adding three pharmaceutical items.

 

PB 30 of 2009 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies.

 

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) (currently PB 30 of 2009).

 

Changes to PB 30 of 2009 made by this instrument

Schedule 1 of the Principal Instrument (PB 30 of 2009) is amended by the addition of the listed drugs aclidinium with eformoterol; and tiotropium with olodaterol.

 

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 30 of 2009 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 30 of 2009.

 

Consultation

The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the pharmaceutical items referred to in this amendment be included in an instrument under subsection 84AAA(2).

 

PBAC is independent of Government and includes members from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. 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 PBAC.

 

This amendment is minor and machinery in nature.

 

General

This Instrument commences on 1 December 2015.

 

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


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 2015 (No. 10) – specification under subsection 84AAA(2)

(PB 110 of 2015)

 

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
2015 (No. 10) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) 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.

 

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.

 

 

Penny Shakespeare

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 10) is a legislative instrument that amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which specifies the pharmaceutical items for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. Enacted under subsection 84AAA(2) of the National Health Act 1953, the instrument was introduced to address the gap in ensuring that certain pharmaceuticals are not subject to PBS Safety Net entitlements when supplied early. This amendment was made in response to recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body that includes members from various health-related professions and interests, ensuring that the decisions are evidence-based and comprehensive. The policy objective is to assist with the progressive realisation of the right to the highest attainable standard of physical and mental health, as outlined in the International Covenant on Economic, Social and Cultural Rights.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 10) – specification under subsection 84AAA(2) is an amendment to the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which specifies pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This amendment applies to pharmaceutical items and is intended to improve access to medicines by ensuring that certain early supplies of specified drugs do not affect PBS Safety Net entitlements. It applies across Australia as a legislative instrument made under the National Health Act 1953, which has jurisdiction over the PBS. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the inclusion of the specified pharmaceutical items, ensuring that the decisions are evidence-based. The amendment does not specify exclusions or thresholds beyond the criteria for early supply outlined in the Act, and it operates as a minor and machinery amendment, relying on the Acts Interpretation Act 1901 for variation and revocation unless explicitly stated otherwise in the instrument.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 10) – specification under subsection 84AAA(2) (PB 110 of 2015) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) by adding three pharmaceutical items. These amendments are designed to specify pharmaceutical items for which the Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies (subsection 84AAA(2)). The primary purpose of this legislative instrument is to provide clarity and additional specifications regarding early supplies of certain pharmaceutical benefits under the National Health Act 1953 (the Act). The added pharmaceutical items are aclidinium with eformoterol and tiotropium with olodaterol. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended these additions, which are intended to enhance the regulation of early pharmaceutical supplies and ensure appropriate access to these medications. The Act imposes several obligations on parties and entities governed by this legislative instrument. Firstly, the Pharmaceutical Benefits Advisory Committee (PBAC) must make recommendations to the Minister regarding the pharmaceutical items that should be specified in the instrument under subsection 84AAA(2) (subsection 101(3AA)). The PBAC is required to ensure that these recommendations are evidence-based and contribute to the progressive realisation of the right to the highest attainable standard of physical and mental health. Secondly, suppliers of pharmaceutical benefits must ensure that any early supply of the specified pharmaceutical items meets the criteria outlined in subsection 84AAA(1). This includes verifying that the supply is not made within 20 days of a previous supply of the same pharmaceutical benefit or one with the same pharmaceutical item or that is Schedule equivalent, and that the supply does not result from a prescription originating from a hospital. Failure to adhere to these requirements could result in the supply being considered an early supply, with specific implications under the PBS Safety Net entitlements. There are no specific offences, penalties, or civil/criminal consequences outlined for breaches of the provisions in this legislative instrument. However, the Act does provide for various penalties for breaches of pharmaceutical benefit regulations generally. For example, subsection 109(1) of the Act provides for fines up to 50 penalty units ($9,950 as of 2023) for certain offences related to the supply of pharmaceutical benefits. Additionally, subsection 111A of the Act imposes a fine of up to 100 penalty units ($19,900 as of 2023) for more serious offences. These penalties reflect the importance of compliance with the regulations governing the supply of pharmaceutical benefits under the National Health Act 1953. The lack of specific penalties in this instrument suggests that the primary focus is on regulatory compliance and ensuring that early supplies of specified pharmaceutical items are appropriately managed within the PBS framework.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Licensing & Registration
Reporting & Disclosure Obligations
Regulatory Standards

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.