National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 5) (PB 46 of 2017)

Administered by Department of Health, Disability and Ageing

Legislation au F2017L00774 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (PHARMACEUTICAL BENEFITS – EARLY SUPPLY) AMENDMENT INSTRUMENT 2017 (No. 5)

PB 46 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

(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).

 

Changes to PB 120 of 2015 made by this instrument

Schedule 1 to the Principal Instrument is amended by the addition of the listed drug pirfenidone.  The Schedule is further amended by the addition of adalimumab in the form injection 40 mg in 0.8 mL pre-filled pen, 4; and rotigotine in the form transdermal patch
18 mg.

 

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 July 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. 5)

(PB 46 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

The National Health (Pharmaceutical benefits – early supply) Amendment Instrument 2017 (No. 5) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015 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.

Penny Shakespeare
First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 5) was enacted to amend the National Health (Pharmaceutical benefits—early supply) Instrument 2015, addressing the issue of early supplies of specified pharmaceutical benefits for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements do not apply. This legislative instrument was introduced by the Australian Government under subsection 84AAA(2) of the National Health Act 1953. The purpose is to refine the list of pharmaceutical items specified in the 2015 instrument, ensuring that certain medications are appropriately excluded from the PBS safety net for early supplies. This amendment aims to maintain the integrity and sustainability of the PBS by preventing unnecessary early supplies of certain drugs, thereby protecting the financial viability of the scheme and ensuring equitable access to essential medications. The Pharmaceutical Benefits Advisory Committee (PBAC) was involved in the consultation process, providing expert recommendations on the pharmaceutical items to be specified in the amended instrument. This committee, composed of members with diverse expertise in health and pharmaceuticals, ensures that decisions about the PBS are evidence-based and aligned with public health objectives. The changes introduced by this legislative instrument are considered minor and are intended to enhance the efficiency and effectiveness of the PBS by better managing the supply of specified pharmaceutical benefits.

Scope and Application

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 5) amends the National Health (Pharmaceutical benefits—early supply) Instrument 2015, 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 instrument applies to pharmaceutical items specified in the Schedule, namely pirfenidone, adalimumab in the form of injection 40 mg in 0.8 mL pre-filled pen, and rotigotine in the form of a transdermal patch 18 mg, ensuring that these items are subject to the conditions outlined for early supply under the National Health Act 1953. This legislative instrument operates on a Commonwealth level, affecting entities and individuals involved in the supply and administration of pharmaceutical benefits under the PBS. The instrument's provisions are designed to refine the criteria for early supply of specified pharmaceutical benefits, thereby impacting the pharmaceutical industry and healthcare providers within Australia. The instrument is a minor amendment, relying on existing provisions of the Act and does not introduce new exclusions or thresholds, but rather modifies the existing list of pharmaceutical items subject to early supply conditions.

Key Provisions

The National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 5) amends the National Health (Pharmaceutical Benefits—Early Supply) Instrument 2015. Specifically, it adds three pharmaceutical items to the list of those for which Pharmaceutical Benefits Scheme (PBS) safety net entitlements will not apply for early supplies. These items are pirfenidone, adalimumab in the form of injection 40 mg in 0.8 mL pre-filled pen, and rotigotine in the form of a transdermal patch 18 mg. This amendment ensures that these items, when supplied within 20 days of a previous supply, are considered early supplies (subsection 84AAA(1) of the National Health Act 1953). The Pharmaceutical Benefits Advisory Committee (PBAC) has provided recommendations to the Minister for these additions, ensuring that the decisions are evidence-based and in line with the objectives of the PBS. The Act imposes obligations on the parties involved, including the Minister and the PBAC. The Minister is authorised to specify pharmaceutical items via legislative instruments under subsection 84AAA(2) of the Act. The PBAC, as an independent expert body, must provide recommendations to the Minister about which drugs should be available as pharmaceutical benefits. These recommendations are integral in ensuring that the PBS provides access to necessary medications in a manner that is both efficient and evidence-based. The amendments made by this instrument are based on these recommendations and aim to align the PBS with current medical needs and practices. Breaches of the provisions outlined in this Act can lead to civil or criminal penalties. For instance, subsection 101A(2) of the Act imposes penalties for misleading or deceptive conduct in relation to pharmaceutical benefits, with the maximum penalty being 500 penalty units or imprisonment for five years, or both, for individuals, and 2,500 penalty units for bodies corporate. Additionally, subsection 101A(3) stipulates that in determining the penalty for an offence against subsection 101A(2), the court must consider any benefit that has accrued, or is likely to accrue, to the person or body corporate from the conduct. These provisions ensure that the integrity of the PBS is maintained, and that all parties adhere to the legislative requirements. In summary, the National Health (Pharmaceutical Benefits – Early Supply) Amendment Instrument 2017 (No. 5) modifies the list of pharmaceutical items for which PBS safety net entitlements do not apply for early supplies. This change is grounded in recommendations from the PBAC and aims to ensure that the PBS continues to provide accessible and necessary medications to Australians. The Act outlines specific obligations for the Minister and the PBAC and imposes penalties for non-compliance, thereby maintaining the integrity and effectiveness of the PBS.

Legal classification tags

Area of Law
Health Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Reporting & Disclosure Obligations
Catchwords
Pharmaceutical Benefits Scheme
Early Supply

Interactions

Authorises

All Versions

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.