National Health Act (Pharmaceutical Benefits - Early Supply) Amendment May 2013 - specification under subsection 84AAA(2) (No. PB 28 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00705 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH ACT (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT MAY 2013 – SPECIFICATION UNDER SUBSECTION 84AAA(2)

 

PB 28 of 2013

 

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) to insert a new pharmaceutical item and delete an existing pharmaceutical item.

 

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

 

This instrument deletes an existing pharmaceutical item that has the listed drug ‘Cimetidine’, the form ‘Tablet 800 mg’ and an ‘oral’ manner of administration, and inserts a new pharmaceutical item that has the listed drug ‘Temozolomide’, the form ‘Capsule 180 mg’ and an ‘oral’ manner of administration.

 

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 2010.

 

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.

 

Consultation

 

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

 

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.  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 May 2013.

 

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


Statement of Compatibility with Human Rights

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

 

National Health Act (Pharmaceutical Benefits – Early Supply) Amendment May 2013 - specification under subsection 84AAA(2)

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 Act (Pharmaceutical Benefits – Early Supply) Amendment May 2013 - 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.

 

 

 

Karen Binnekamp

Acting Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

 

Overview

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment May 2013 – specification under subsection 84AAA(2) is an amendment to the National Health Act 1953, introduced to address a gap in the regulation of early supplies of certain pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS). This amendment was enacted by the Parliament of Australia and is designed to modify the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. Its policy objective is to ensure that the PBS Safety Net entitlements do not apply to early supplies of specified pharmaceutical items, thereby maintaining the integrity of the scheme while providing necessary adjustments based on expert recommendations. This amendment specifically involves the deletion of an existing pharmaceutical item and the addition of a new one, reflecting the recommendations made by the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment May 2013 – specification under subsection 84AAA(2) applies to the Pharmaceutical Benefits Scheme (PBS) and affects the eligibility of certain pharmaceutical items for the PBS Safety Net when supplied as early supplies. This legislation specifically modifies the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by removing the pharmaceutical item 'Cimetidine' and adding 'Temozolomide'. It applies to individuals who receive pharmaceutical benefits under the PBS and the entities responsible for supplying these benefits, primarily focusing on the conduct of supplying pharmaceutical items and the transactions involved. The amendment is made under the authority of the National Health Act 1953 and has a national reach, affecting all jurisdictions within Australia. There are no exclusions, exemptions, or thresholds specified in this amendment; however, the application of the Act can be extended or restricted through subordinate instruments made by the Minister under subsection 84AAA(2) of the Act. This legislative instrument is compatible with human rights as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health through evidence-based decision-making facilitated by the Pharmaceutical Benefits Advisory Committee.

Key Provisions

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment May 2013 – specification under subsection 84AAA(2) primarily modifies the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, as detailed in PB 30 of 2009, by removing the pharmaceutical item listing Cimetidine, form Tablet 800 mg, and manner of administration oral, and adding a new pharmaceutical item listing Temozolomide, form Capsule 180 mg, and manner of administration oral (subsection 84AAA(2)). This amendment ensures that certain pharmaceutical benefits are excluded from PBS Safety Net entitlements when supplied early. The Act imposes specific obligations on the Pharmaceutical Benefits Advisory Committee (PBAC), which is required to make recommendations to the Minister regarding the specification of pharmaceutical items under subsection 84AAA(2) (subsection 101(3AA)). The PBAC’s recommendations are crucial as they ensure that decisions on which pharmaceutical items are included in the list are evidence-based and consider the impact on patient access to essential medications. Furthermore, the Act mandates that the Minister may specify pharmaceutical items by legislative instrument, as stipulated in subsection 84AAA(2). Failure to comply with the provisions of this legislative instrument may result in legal consequences. Specifically, supplying a pharmaceutical benefit that is not correctly specified as an early supply could lead to penalties under the National Health Act 1953. Although the exact penalties are not detailed in the explanatory statement, breaches of the Act can typically result in significant fines and other civil or criminal penalties as prescribed by the relevant legislation. These penalties are designed to enforce adherence to the specified pharmaceutical items and ensure the integrity of the Pharmaceutical Benefits Scheme.

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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.