National Health (Originator Brand) Amendment Determination 2019 (No. 2) (PB 25 of 2019)

Administered by Department of Health, Disability and Ageing

Legislation au F2019L00467 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

 

National Health Act 1953

 

National Health (Originator Brand) Amendment Determination 2019 (No. 2)

 

PB 25 of 2019

Authority

This legislative instrument is made pursuant to subsection 99ADB(6B) of the National Health Act 1953 (the Act).

Purpose

This legislative instrument amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) (the Principal Instrument) to determine the originator brands of pharmaceutical items for one drug moving to the Pharmaceutical Benefits Scheme (PBS) F2 formulary, in addition to another brand of a drug already on F2 with a change to the manner of administration.  Both these changes take effect on 1 April 2019.

The Principal Instrument determines originator brands of pharmaceutical items that have a drug on the F2 formulary.  On meeting certain criteria, drugs move from the F1 formulary (see s 85AB of the Act), or the single brand Combination Drug List (CDL), to F2.  All drugs on F2 are subject to price disclosure.  This instrument is necessary to implement removal of originator brand data from price disclosure calculations (originator removal) in certain circumstances as set out in the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).  Originator removal will potentially increase price disclosure related price reductions because originator brands tend to maintain higher prices than other brands.

Amendments

An originator brand determination is set out in Schedule 1 of this amending instrument for one drug that is moving from F1 to F2 (atazanavir) in addition to another drug already in F2 (dexamethasone) with a change to the manner of administration.  Subsection 99ADB(6C) of the Act provides that when deciding whether to determine originator brands the Minister (or delegate) must have regard to whether the brand was on F1 or CDL when it was first determined as a brand of pharmaceutical item under subsection 85(6) of the Act. 

The main criteria used to determine these brands as originators were that they were the listed brands of the drug when it was on F1 or CDL.

Basis for amendments

Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(6B) for the medicines affected by this amending instrument.

Consultation

The company with a PBS listed brand of the drug for which an originator brand has been determined was asked for comments in relation to the potential originator brand determination.  No comments were received. 

This instrument commences on 1 April 2019.

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 (Originator Brand) Amendment Determination 2019 (No. 2) (PB 25 of 2019)

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

This legislative instrument amends the National Health (Originator Brand) Determination 2015 (PB 100 of 2015) (the Principal Instrument) to determine originator brands of pharmaceutical items for one drug new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary in addition to another drug already on F2 with a change to the manner of administration.

The instrument is necessary to implement removal of originator brand data for price disclosure calculations (originator removal) in certain circumstances as set out in the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).  Originator removal will potentially increase PBS price reductions as originator brands tend to maintain higher prices than other brands.  Originator removal means that the Government price would more closely reflect the prices at which generic brands of the medicine are being sold in the market, not the prices of all brands.

The PBS provides Australians with timely, reliable and affordable access to necessary and
cost-effective medicines.  The PBS operates under Part VII of the National Health Act 1953 (the Act) which regulates the listing, prescribing, pricing, charging and payment of subsidies for supply of drugs and medicinal preparations as pharmaceutical benefits.  The Regulations prescribe matters and set out details in relation to the operation of the PBS.

Human rights implications

This legislative instrument is compatible with Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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 assists with advancement of this human right by providing subsidised access to medicines for Australians.

Originator removal will improve the operation of the PBS by delivering better value for money for PBS medicines through price reductions.  This will assist consumers by reducing out-of-pocket costs for some PBS medicines.

Conclusion

This legislative instrument is compatible with human rights as it advances the protection of human rights.

 

 

 

Thea Daniel

Assistant Secretary

 Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Originator Brand) Amendment Determination 2019 (No. 2) is an amendment to the National Health (Originator Brand) Determination 2015, made under subsection 99ADB(6B) of the National Health Act 1953. This legislative instrument aims to address the issue of originator brand data in price disclosure calculations for pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS) F2 formulary, thereby potentially increasing price reductions and making medicines more affordable for consumers. Enacted by the Parliament of Australia, this determination is designed to implement the removal of originator brand data in certain circumstances, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The overarching policy objective is to ensure the PBS operates effectively, providing timely, reliable, and affordable access to necessary medicines, while also advancing human rights by improving the availability of cost-effective medications to Australians.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2019 (No. 2) amends the National Health (Originator Brand) Determination 2015 to determine the originator brands of pharmaceutical items for specific drugs moving to the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This applies to atazanavir, a drug newly moving from the F1 formulary to F2, and dexamethasone, a drug already on F2 but with a change to the manner of administration. The amendment takes effect from 1 April 2019. The Act applies to entities involved in the supply of pharmaceutical benefits, particularly those administering the PBS. Geographically, this applies across Australia as the Act is a Commonwealth statute. The determination is necessary to implement the removal of originator brand data from price disclosure calculations, which may lead to price reductions and better value for consumers. The amendment is made under the authority of subsection 99ADB(6B) of the National Health Act 1953, with no specific exclusions noted in the text, though the application is limited to the drugs specified in the amendment.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2019 (No. 2) amends the National Health (Originator Brand) Determination 2015 (section 4). This amendment primarily concerns the determination of originator brands for pharmaceutical items, specifically for atazanavir which is moving from the F1 to the F2 formulary, and dexamethasone which is already in F2 but with a change in the manner of administration (Schedule 1). The amendment takes effect on 1 April 2019, and the criteria for determining these originator brands are based on the brands' status when they were first listed under subsection 85(6) of the National Health Act 1953. These brands are considered originators because they were the listed brands when the drugs were on F1 or on the Combination Drug List (CDL). The Act imposes obligations on the parties and entities it governs, particularly concerning the determination of originator brands and their impact on pricing. Originator brands play a crucial role in the Pharmaceutical Benefits Scheme (PBS) pricing structure, and their identification helps in ensuring that price disclosure calculations are accurate and reflect market realities. The Regulations further outline the details and matters related to the operation of the PBS, including the implications of originator removal for price reductions. The PBS is designed to provide Australians with access to necessary and cost-effective medicines, and the accurate determination of originator brands ensures that the scheme operates efficiently and fairly. The determination of originator brands under this instrument is necessary to implement the removal of originator brand data from price disclosure calculations, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. This originator removal can lead to increased price reductions on the PBS because originator brands often maintain higher prices than generic brands. By removing originator brand data, the government price more accurately reflects the prices at which generic brands are sold in the market. This change is intended to improve the value for money in the PBS, ultimately reducing out-of-pocket costs for consumers. In terms of consequences for non-compliance, the Act does not explicitly state specific offences, penalties, or consequences for breach in this amendment. However, any breaches related to the PBS or its regulations could potentially lead to civil or criminal penalties as outlined in the broader framework of the National Health Act 1953 and associated regulations. The penalties could include fines or other sanctions, depending on the nature and severity of the breach. The exact penalties would be determined in accordance with the relevant provisions of the Act and the Regulations.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Statutory Instrument
Concepts
Definitions & Interpretation
Reporting & Disclosure Obligations
Regulatory Standards

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.