National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 8) – specification under subsection 84AAA(2) (PB 92 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01608 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2014 (No. 8) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 92 of 2014

 

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: inserting three 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 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: enzalutamide; umeclidinium; and umeclidinium with vilanterol.

 

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 2014.

 

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 2014 (No. 8) – specification under subsection 84AAA(2)

(PB 92 of 2014)

 

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 2014 (No. 8) – 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.

 

 

Felicity McNeill

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

 

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 8) – specification under subsection 84AAA(2) (PB 92 of 2014) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009, which specifies the pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This amendment was introduced to address the need to update the list of pharmaceutical items that qualify for early supply without PBS Safety Net entitlements. The instrument was made under the authority of the National Health Act 1953, with the objective of ensuring that the PBS remains effective in providing access to essential medications while maintaining the integrity of the Safety Net scheme. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended the inclusion of these pharmaceutical items based on their assessment of their clinical and economic value. The instrument was created under the authority of the Australian Parliament and specifies the insertion of three new pharmaceutical items: enzalutamide, umeclidinium, and umeclidinium with vilanterol, into the list of items for which early supply does not attract PBS Safety Net entitlements. The PBAC, which comprises experts from various relevant fields, provided recommendations for these inclusions. This legislative amendment ensures that the PBS continues to be responsive to new therapeutic needs while preserving the financial sustainability of the Safety Net scheme. The instrument is compatible with human rights, as it supports the progressive realisation of the right to health by facilitating timely access to necessary medications.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 8) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by adding three new pharmaceutical items to the list of those for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements do not apply for early supplies. This legislative instrument applies to individuals and entities involved in the supply of pharmaceutical benefits within Australia, particularly in relation to the Pharmaceutical Benefits Scheme. The instrument operates under the authority granted by subsections 84AAA(1) and 84AAA(2) of the National Health Act 1953, which permit the Minister to specify pharmaceutical items through legislative instruments. The amendment is effective across the Commonwealth of Australia and is intended to ensure that certain medications receive appropriate consideration under the PBS without triggering Safety Net entitlements for early supplies. The changes made by this instrument are in response to recommendations from the Pharmaceutical Benefits Advisory Committee, which is composed of experts from various health-related fields. The instrument became effective on 1 December 2014 and is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 8) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 by adding three new pharmaceutical items to the list of items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements do not apply for early supplies. These new items are enzalutamide, umeclidinium, and umeclidinium with vilanterol (subsection 84AAA(2)). The amendment specifies these pharmaceutical items in Schedule 1 of PB 30 of 2009, detailing their form, manner of administration, maximum quantity or number of units, and maximum number of repeats. These declarations and determinations are in accordance with the Act and are made in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). Under the Act, parties governed by this Amendment Instrument must ensure that the specified pharmaceutical items are correctly identified and that supplies of these items are managed in accordance with the criteria set out in subsection 84AAA(1). This includes ensuring that the supply of these items does not occur within 20 days of a previous supply of the same or a similar item, unless it is exempt under the Act, such as being from a hospital prescription (subsection 84AAA(1)(a) and (b)). The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in advising the Minister on the pharmaceutical items to be included in such instruments, ensuring that the decisions are evidence-based and contribute to the progressive realisation of the right to health (subsection 101(3AA)). Breaching the provisions of this Amendment Instrument can result in significant consequences. For example, if a supply of a specified pharmaceutical item occurs within the prohibited 20-day period, it may be considered an early supply, potentially leading to civil penalties for providers and pharmacists. The Act outlines the specific penalties for non-compliance, which can include fines and other sanctions. The exact penalties are determined in accordance with the provisions of the Act and may vary depending on the nature and severity of the breach. Additionally, the Act includes provisions for the revocation or variation of the instrument, ensuring that it can be updated as necessary to reflect changes in medical practices, pharmaceutical advancements, or other relevant factors. The Amendment Instrument is designed to ensure that the PBS continues to provide timely and appropriate access to essential medications while maintaining the integrity of the scheme.

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Health Law
Pharmaceutical Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Consultation Requirements
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Pharmaceutical Benefits Scheme

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