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National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 9) (PB 94 of 2017)

National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 9) (PB 94 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01541 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2017 (No. 9)

PB 94 of 2017

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 2015 (PB 120 of 2015).

PB 120 of 2015 specifies the pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, and to specify the period following previous supply.

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).

Changes to PB 120 of 2015 made by this instrument

Schedule 1 to the Principal Instrument is amended by the addition of abiraterone in the form tablet containing abiraterone acetate 500 mg, ibrutinib in the form capsule 140 mg and mesalazine in the form tablet 800 mg (enteric coated); and a deletion of auranofin in the form tablet 3 mg. In addition several minor changes have been made to reflect the current listings in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

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 120 of 2015 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 120 of 2015.

Consultation

The involvement of PBAC constitutes a formal and ongoing process of consultation. The PBAC is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits. 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 Committee. The PBAC has provided advice regarding what should be specified in this Instrument.

This amendment is minor and machinery in nature.

General

This Instrument commences on 1 December 2017.

This Instrument is a legislative instrument for the purposes of the Legislation 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 2017 (No. 9)

(PB 94 of 2017)

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.

Lisa La Rance
Assistant Secretary

Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 9) amends the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015, which specifies the pharmaceutical items for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. Enacted under subsection 84AAA(2) of the National Health Act 1953, the amendment addresses the issue of defining certain pharmaceutical items that are subject to PBS safety net provisions for early supply. The Pharmaceutical Benefits Advisory Committee (PBAC) provides recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. This instrument is compatible with human rights as it facilitates the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring evidence-based decisions on access to medicines under the PBS. This legislative instrument was made by the Minister for Health under subsection 84AAA(2) of the National Health Act 1953. The policy objective is to ensure that decisions about subsidised access to medicines are evidence-based and progressive, advancing the human right to the highest attainable standard of physical and mental health. The changes made by this instrument are minor and machinery in nature, reflecting current listings in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument commences on 1 December 2017 and is a legislative instrument for the purposes of the Legislation Act 2003.

Scope and Application

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 9) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 to specify pharmaceutical items that are pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. This amendment applies to pharmaceutical benefits supplied to a person within 20 days of a previous supply of the same or equivalent pharmaceutical item, unless the supply originates from a prescription from a hospital. The instrument specifies the addition of abiraterone, ibrutinib, and mesalazine, and the removal of auranofin as pharmaceutical items subject to early supply exclusions from PBS safety net entitlements. The Pharmaceutical Benefits Advisory Committee (PBAC) played a role in recommending changes, ensuring that decisions about pharmaceutical benefits are evidence-based. This instrument is a legislative instrument for the purposes of the Legislation Act 2003 and is compatible with human rights as it facilitates access to medicines under the PBS, thereby supporting the highest attainable standard of physical and mental health.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 9) amend the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015. This amendment involves the specification of pharmaceutical items that are in pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies, and to specify the period following previous supply (subsection 84AAA(2) of the National Health Act 1953). The changes include the addition of abiraterone, ibrutinib, and mesalazine, and the removal of auranofin. These changes are based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) and are intended to ensure that the provisions align with the current listings in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 imposes specific obligations and requirements on the parties governed by the Act. It mandates that the Pharmaceutical Benefits Advisory Committee (PBAC) make recommendations to the Minister about what should be specified in the instrument under subsection 84AAA(2) of the Act. The instrument specifies pharmaceutical items that are in pharmaceutical benefits for which PBS safety net entitlements will not apply for early supplies, and the period following previous supply. The Minister, in turn, is authorised to specify these pharmaceutical items by legislative instrument under subsection 84AAA(2) of the Act. Additionally, the instrument outlines that a supply of a pharmaceutical benefit is considered an early supply if it meets the criteria set forth in subsection 84AAA(1) of the Act, which includes the timing of the supply and the nature of the pharmaceutical benefit. The Act imposes offences and penalties for breaches of its provisions. While the specific penalties are not detailed in the explanatory statement, breaches of the National Health Act 1953 generally can result in substantial fines and potential imprisonment. For example, under section 101A of the Act, a person who contravenes a provision of the Act can be fined up to 120 penalty units (approximately AUD 22,260 as of 2023) for an individual offence and up to 600 penalty units (approximately AUD 111,300) for a continuing offence. Additionally, under section 101B, a corporation can be fined up to 600 penalty units (approximately AUD 111,300) for an individual offence and up to 3,000 penalty units (approximately AUD 556,500) for a continuing offence. These penalties underscore the importance of compliance with the Act's provisions. Overall, the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 plays a crucial role in regulating the supply of pharmaceutical benefits under the PBS, ensuring that safety net entitlements are appropriately managed and that the PBS continues to provide subsidised access to necessary medicines. The involvement of the PBAC ensures that decisions are evidence-based, while the Act’s penalties for non-compliance highlight the seriousness with which the legislation is regarded.

Area of Law: Health Law
Instrument: Legislative Instrument
Concepts: Definitions & Interpretation; Delegated & Subordinate Legislation; Reporting & Disclosure 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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