National Health Act (Pharmaceutical Benefits – Early Supply) Amendment April 2012 - specification under subsection 84AAA(2) (No. PB 24 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L00710 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH ACT (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT APRIL 2012 – SPECIFICATION UNDER SUBSECTION 84AAA(2)

 

PB 24 of 2012

 

Purpose

The purpose of this legislative instrument, made under subsection 84AAA(2) of the National Health Act 1953 (the Act) is to amend Schedule 1 of the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) to insert two new pharmaceutical items, delete an existing pharmaceutical item, and amend 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 Veteran’s 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) 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 inserts two new pharmaceutical items, the first having the listed drug ‘Abatacept’, the form ‘Injection 125 mg in 1 mL single dose pre-filled syringe’ and an ‘Injection’ manner of administration and the second having the listed drug ‘Nilotinib’, the form ‘Capsule 150 mg (as hydrochloride monohydrate)’ and an ‘Oral’ manner of administration.

 

This instrument also deletes the existing pharmaceutical item that has the listed drug ‘Oestradiol’, the form ‘Transdermal patches 8 mg, 8’ and a ‘Transdermal’ manner of administration; and changes the maximum quantity for the existing pharmaceutical item that has the listed drug ‘Nilotinib’, the form ‘Capsule 200 mg (as hydrochloride monohydrate)’ and an ‘Oral’ manner of administration from 112 to 120.

 

The ‘listed drug’, ‘form’, ‘manner of administration’ ‘maximum quantity or number of units’ and ‘maximum number of repeats’ for these pharmaceutical items are the same as declared and determined under the Act for pharmaceutical benefits that have these pharmaceutical items. These declarations and determinations are made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2010.

 

A supply of a pharmaceutical benefit that has a specified pharmaceutical item will be an early supply of a specified pharmaceutical benefit if the provisions of subsection 84AAA(1) are met.

 

Consultation

The PBAC has made recommendations regarding the pharmaceutical items referred to in this amendment for the purposes of 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 April 2012.

 

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

 

 

Overview

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment April 2012 – Specification under subsection 84AAA(2) was enacted in 2012 to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009). The amendment introduces two new pharmaceutical items, removes an existing one, and modifies the maximum quantity of another, all in relation to early supplies of pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) that do not incur PBS Safety Net entitlements. This legislative instrument is made under the authority of the National Health Act 1953 and aims to address the classification of specific pharmaceutical items for early supply, ensuring they do not trigger PBS Safety Net entitlements. The Pharmaceutical Benefits Advisory Committee (PBAC) provided recommendations for these changes, reflecting its role in advising the Minister on the specification of pharmaceutical items under the Act. The amendment is minor and primarily addresses the machinery of the scheme by specifying certain pharmaceutical items for early supply purposes.

Scope and Application

The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment April 2012 – Specification under Subsection 84AAA(2) modifies Schedule 1 of the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, clarifying the pharmaceutical items that are excluded from Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies. This legislation applies to the pharmaceutical items specified under the Act, which are provided under the PBS, thereby impacting the pharmaceutical industry, health practitioners, and patients who receive pharmaceutical benefits. The amendment is applicable nationally, as it pertains to the Commonwealth's regulation of the PBS. The changes include the addition of two new pharmaceutical items—Abatacept and Nilotinib—and the deletion of an existing pharmaceutical item—Oestradiol. Additionally, the quantity of Nilotinib capsules has been adjusted from 112 to 120. These changes are effective as of 1 April 2012 and are made under the authority of the Minister, who may specify pharmaceutical items by legislative instrument under subsection 84AAA(2) of the Act. The Pharmaceutical Benefits Advisory Committee provided recommendations for these amendments, reflecting a collaborative approach to the regulation of pharmaceutical benefits in Australia.

Key Provisions

The main operative sections of the National Health Act (Pharmaceutical Benefits – Early Supply) Amendment April 2012 involve the insertion of two new pharmaceutical items, the deletion of an existing pharmaceutical item, and the amendment of an existing pharmaceutical item within Schedule 1 of the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009. Section 84AAA(2) of the Act allows the Minister to specify pharmaceutical items through a legislative instrument, and this amendment implements those specifications by altering the schedule to include the new items and remove the specified existing item. Furthermore, the amendment modifies the maximum quantity of an existing pharmaceutical item from 112 to 120. The Act imposes several obligations on parties and entities it governs, primarily through the Pharmaceutical Benefits Scheme (PBS) Safety Net. The new and amended pharmaceutical items must adhere to the specifications outlined in the National Health (Listing of Pharmaceutical Benefits) Instrument 2010. These specifications include the listed drug, form, manner of administration, maximum quantity, and maximum number of repeats for each pharmaceutical item. The Pharmaceutical Benefits Advisory Committee (PBAC) is responsible for making recommendations to the Minister on what should be specified in the instrument under subsection 84AAA(2), ensuring that the amendments align with health and safety standards. In terms of offences, penalties, or consequences for breach, the Act does not explicitly detail these within the explanatory statement. However, breaches of the Act or its regulations can result in civil or criminal penalties, depending on the nature and severity of the breach. The maximum penalties may vary, but under the National Health Act 1953, offences can lead to substantial fines, imprisonment, or both, depending on the provisions breached and the jurisdiction in which the offence occurred. It is essential for parties and entities to comply with the legislative requirements to avoid potential legal repercussions.

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