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National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2015 (No. 8) - specification under subsection 84AAA(2) (PB 93 of 2015)

National Health (Pharmaceutical Benefits - Early Supply) Amendment Instrument 2015 (No. 8) - specification under subsection 84AAA(2) (PB 93 of 2015)

Administered by Department of Health, Disability and Ageing

Legislation au F2015L01540 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2015 (No. 8) – SPECIFICATION UNDER SUBSECTION 84AAA(2)

PB 93 of 2015

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: adding several 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

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 tofacitinib and the deletion of fluvastatin in the forms capsule 20 mg (as sodium) and capsule 40 mg (as sodium).

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 October 2015.

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 2015 (No. 8) – specification under subsection 84AAA(2)

(PB 93 of 2015)

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

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.

Kylie Jonasson

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 8) is an instrument made under the National Health Act 1953, aiming to address the need for updating the list of pharmaceutical items that qualify for certain exemptions under the Pharmaceutical Benefits Scheme (PBS) Safety Net for early supplies. This legislative instrument was enacted to amend the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) by adding new pharmaceutical items, thereby ensuring the scheme remains relevant and effective in providing necessary medications. The Pharmaceutical Benefits Advisory Committee (PBAC) recommended these changes, ensuring they are evidence-based and align with the broader objectives of the PBS. This amendment facilitates the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights. This instrument specifies the addition of the pharmaceutical item tofacitinib and the removal of fluvastatin in particular forms, aligning with the requirements outlined in the National Health Act 1953. The changes are designed to streamline the process of providing early supplies of certain pharmaceuticals while maintaining the integrity and purpose of the PBS Safety Net. The Pharmaceutical Benefits Advisory Committee, comprising experts from various relevant fields, ensures the recommendations are comprehensive and balanced. The instrument's compatibility with human rights is affirmed, highlighting its role in advancing health rights by providing subsidised access to essential medicines.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 8) – specification under subsection 84AAA(2) amends 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 legislative instrument applies to pharmaceutical items listed in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which determines the form, manner of administration, maximum quantity, and maximum number of repeats for these items. The amendment adds the drug tofacitinib to the list of pharmaceutical items for which PBS Safety Net entitlements do not apply for early supplies, while removing fluvastatin in the forms capsule 20 mg (as sodium) and capsule 40 mg (as sodium) from the list. This change is made based on recommendations from the Pharmaceutical Benefits Advisory Committee, an independent body that includes members from various relevant professions. The instrument operates under the National Health Act 1953 and is applicable nationally, affecting all entities and individuals involved in the supply of pharmaceutical benefits within Australia. The instrument does not specify exclusions, exemptions, or thresholds beyond the listed pharmaceutical items, and any further specification or restriction of its application would be made through subordinate instruments.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 8) amends the National Health (Pharmaceutical Benefits – Early Supply) Instrument 2009 – specification under subsection 84AAA(2) (PB 30 of 2009) to add several pharmaceutical items that are excluded from Pharmaceutical Benefits Scheme (PBS) Safety Net entitlements for early supplies (subsection 84AAA(2)). Specifically, the amendment involves the addition of the listed drug tofacitinib and the removal of fluvastatin in the forms capsule 20 mg (as sodium) and capsule 40 mg (as sodium) from the list of excluded pharmaceutical items (Schedule 1). This amendment is made under the authority provided by subsection 84AAA(1) of the National Health Act 1953, which defines early supply conditions and subsection 84AAA(2), which allows the Minister to specify pharmaceutical items by legislative instrument. Entities and parties governed by the Act must comply with the conditions specified in the Act, particularly in relation to early supply of pharmaceutical benefits. This includes understanding the criteria for early supply, such as the 20-day period after a previous supply of the same or equivalent pharmaceutical benefit (subsection 84AAA(1)). For the pharmaceutical items added or removed by this amendment, it is crucial to note these changes and ensure that any supplies meet the criteria for early supply or are appropriately documented and billed to avoid unintended consequences under the PBS Safety Net. The Act imposes certain obligations on entities and parties it governs. For example, pharmaceutical suppliers must ensure that the timing of supplies adheres to the 20-day rule to avoid classifying supplies as early. Healthcare providers must be aware of the specific pharmaceutical items that are exempt from PBS Safety Net entitlements for early supplies, as outlined in the amended instrument. Failure to comply with these provisions could result in incorrect billing or reimbursement issues. Under the National Health Act 1953, there are potential civil and criminal consequences for breaches of the Act's provisions. While specific penalties are not detailed in the Explanatory Statement, breaches of the Act can generally lead to fines, civil penalties, or other legal actions. The severity of penalties can depend on the nature and extent of the breach, and could include substantial financial penalties for repeated or willful violations. The Act also provides for the possibility of prosecution for serious breaches, which could result in additional criminal penalties. In summary, the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2015 (No. 8) modifies the list of pharmaceutical items exempt from PBS Safety Net entitlements for early supplies, reflecting recommendations by the Pharmaceutical Benefits Advisory Committee. Parties governed by the Act must adhere to the specified conditions to ensure compliance with the PBS and avoid potential penalties for non-compliance.

Area of Law: Health Law; Pharmaceutical Law
Instrument: Statutory Instrument
Concepts: Definitions & Interpretation; Licensing & Registration; Reporting & Disclosure Obligations; Compliance Obligations; Consultation Requirements

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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.

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