EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH ACT (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT DECEMBER – SPECIFICATION UNDER SUBSECTION 84AAA(2)
PB 92 of 2011
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 new 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 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 new pharmaceutical items as set out in Attachment 1.
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. 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 one or more of these pharmaceutical items 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 December 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT 1
Table 1. Drugs added
Dalteparin |
Denosumab |
Indacaterol |
Losartan |
Pramipexole |
Overview
The National Health Act 1953 was enacted by the Parliament of Australia to provide for the administration of the Pharmaceutical Benefits Scheme (PBS) and other health-related initiatives. The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment 2011, made under subsection 84AAA(2) of the Act, addresses the gap in the early supply provisions of the PBS by specifying certain pharmaceutical items for which PBS Safety Net entitlements will not apply for early supplies. This amendment was introduced to refine the regulation of early pharmaceutical supplies and ensure that they are appropriately managed under the PBS framework.
This legislative instrument was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by inserting new pharmaceutical items specified in Attachment 1. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended these changes based on their expertise in health economics and clinical practice. The amendment specifies that these new pharmaceutical items will be treated as early supplies if supplied within 20 days of a previous supply, in line with the provisions of the Act. This amendment is designed to be minor and focuses on the machinery of the PBS without altering the fundamental principles of the scheme. The changes took effect on 1 December 2011 and are considered a legislative instrument under the Legislative Instruments Act 2003.
Scope and Application
The National Health Act (Pharmaceutical Benefits – Early Supply) Amendment December – Specification under Subsection 84AAA(2) aims to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 to include new pharmaceutical items in the list of those for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This amendment applies to any supply of pharmaceutical benefits that meet the criteria set out in subsection 84AAA(1) of the Act, specifically to a person who receives a supply within 20 days of a previous supply of the same or a similar pharmaceutical benefit, excluding supplies originating from hospital prescriptions. The Act applies to all persons within Australia who are recipients of pharmaceutical benefits, with the amendment extending its reach to include the newly specified pharmaceutical items. The authority for this amendment lies in subsection 84AAA(2) of the Act, which allows the Minister to specify pharmaceutical items via legislative instruments, as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). This legislative instrument is effective from 1 December 2011 and is recognised as a legislative instrument under the Legislative Instruments Act 2003.
Key Provisions
The primary operative sections of this legislative instrument, under the National Health Act 1953 (the Act), are sections 84AAA and 84C(4A). Section 84AAA(2) allows the Minister to specify pharmaceutical items that qualify for early supply under the Pharmaceutical Benefits Scheme (PBS), while section 84C(4A) outlines specific conditions under which certain pharmaceutical benefits are excluded from this scheme. This instrument amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009) by inserting new pharmaceutical items that will not have PBS Safety Net entitlements applied for early supplies (subsection 84AAA(2)). The newly added items are listed in Attachment 1 of this instrument, and include Dalteparin, Denosumab, Indacaterol, Losartan, and Pramipexole.
This Act imposes specific obligations on various parties involved in the pharmaceutical supply chain. Firstly, it requires suppliers to ensure that the pharmaceutical items listed in the amended instrument are supplied within the prescribed timeframes to avoid being classified as early supplies. Secondly, it mandates that these pharmaceutical items must meet the criteria specified under section 84AAA(1) of the Act to qualify as early supplies. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) is required to make recommendations to the Minister regarding the pharmaceutical items to be specified under the Act, as stipulated in subsection 101(3AA).
In terms of offences, penalties, or consequences for breach, the Act does not explicitly outline specific penalties for non-compliance with the early supply provisions. However, breaches of the Pharmaceutical Benefits Scheme or related regulations may result in civil or criminal penalties, depending on the nature and severity of the offence. For instance, misleading or deceptive conduct in relation to pharmaceutical benefits may lead to fines and imprisonment under the Trade Practices Act 1974. Furthermore, failure to comply with the requirements of the Act may result in the loss of eligibility for Pharmaceutical Benefits Scheme payments, which could have significant financial consequences for both patients and suppliers.