National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2014 (No. 7) - specification under subsection 84AAA(2) (No. PB 84 of 2014)

Administered by Department of Health, Disability and Ageing

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2014 (No. 7) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 84 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 one new 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

Schedule 1 of the Principal Instrument (PB 30 of 2009) is amended by the addition of the listed drug indacaterol with glycopyrronium. 

 

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 November 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. 7) – specification under subsection 84AAA(2)

(PB 84 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. 7) – 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. 7) – specification under subsection 84AAA(2) was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2). This amendment was made under the authority of subsection 84AAA(2) of the National Health Act 1953, which allows the Minister to specify pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. The objective of this amendment is to ensure that the PBS remains effective in providing timely access to necessary medications while managing costs effectively. By inserting the pharmaceutical item indacaterol with glycopyrronium into the list of early supply pharmaceuticals, the instrument aims to balance the need for continuous patient care with the constraints of the PBS Safety Net. The amendment was introduced following recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which is independent and includes representatives from various health-related fields. The PBAC’s role in advising on the inclusion of pharmaceutical items ensures that decisions are evidence-based and aligned with public health needs. This legislative instrument is compatible with human rights, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), as it supports the right to the highest attainable standard of physical and mental health by facilitating access to essential medications through the PBS.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 7) – specification under subsection 84AAA(2) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 to specify pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies. This legislative instrument applies to the supply of pharmaceutical benefits to persons, particularly those that are deemed early supplies within 20 days of a previous supply of the same or equivalent pharmaceutical item, unless originating from a hospital prescription. The instrument is made under the authority of the National Health Act 1953, which governs the PBS and its operations. The amendment introduces indacaterol with glycopyrronium as a listed drug in the instrument, thereby excluding it from PBS Safety Net entitlements for early supplies when the specified conditions are met. The instrument does not explicitly state exclusions or thresholds but relies on the existing framework of the National Health Act and related instruments, such as the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, for the declaration and determination of pharmaceutical items. The instrument's scope is national, applying across Australia under the Commonwealth jurisdiction. The amendment is a machinery change recommended by the Pharmaceutical Benefits Advisory Committee, ensuring evidence-based decision-making in the PBS framework.

Key Provisions

The main operative sections of this legislative instrument, specifically the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2014 (No. 7), focus on amending the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 (PB 30 of 2009). This amendment introduces a new pharmaceutical item, indacaterol with glycopyrronium, into the list of pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements will not apply for early supplies (subsection 84AAA(2)). The instrument also specifies the circumstances under which this new pharmaceutical item will be considered an early supply of a specified pharmaceutical benefit, aligning with the criteria outlined in subsection 84AAA(1) of the National Health Act 1953 (the Act) (subsection 84AAA(3)). Under this Act, the obligations imposed on parties or entities primarily concern the compliance with the stipulations regarding early supplies of specified pharmaceutical benefits. Pharmaceutical providers must ensure that supplies of the newly listed pharmaceutical item, indacaterol with glycopyrronium, adhere to the criteria of being an early supply as defined in subsection 84AAA(1). This involves verifying that the supply is made within 20 days of a previous supply of the same or equivalent pharmaceutical item, and that the supply does not originate from a hospital prescription. Additionally, the Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in advising the Minister on what should be specified in the instrument, ensuring that decisions are evidence-based and aligned with public health objectives. In terms of consequences for non-compliance, the Act does not explicitly outline specific offences or penalties related to breaches of the early supply provisions in this context. However, the overarching framework of the National Health Act 1953 and related regulations would apply, potentially involving civil or criminal penalties for non-compliance with health and safety regulations, depending on the severity and intent of the breach. Given the nature of the amendments, penalties would likely align with those prescribed under broader health legislation for similar infractions, though exact penalties would need to be determined within the context of the wider legal framework. Overall, the legislative instrument is designed to ensure that early supplies of certain pharmaceutical items are appropriately regulated, balancing the need for timely access to medications with the financial sustainability of the PBS. By adding indacaterol with glycopyrronium to the list of items exempt from PBS Safety Net entitlements for early supplies, the instrument aims to fine-tune the operation of the PBS, ensuring it remains effective and equitable.

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