National Health (Originator Brand) Amendment Determination 2021 (No. 6)

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01490 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

 

National Health Act 1953

National Health (Originator Brand) Amendment Determination 2021 (No. 6)

PB 116 of 2021

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 brand of a pharmaceutical item for one drug new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This change is taking place on
1 November 2021. 

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 (s85AB 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 (aprepitant) on 1 November 2021. 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.

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 moving from F1 to F2 were consulted on the potential originator brand determination. No comments were received from the affected company. No additional consultation with experts was undertaken regarding this determination because consultation with the affected companies drew on the knowledge of persons with relevant expertise.

This instrument commences on 1 November 2021.

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 2021 (No. 6) (PB 116 of 2021)

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 the originator brand of a pharmaceutical item for one drug new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 November 2021. 

The instrument is necessary to implement removal of originator brand data for price disclosure calculations in certain circumstances as set out in the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations). Originator brand removal from price disclosure calculations will potentially increase PBS price reductions, as originator brands tend to maintain higher prices than other brands. Originator brand 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, 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 engages 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 is a benefits scheme which assists with providing subsidised access to medicines for people. This is a positive and supportive step towards attaining the highest standard of health for all Australians.

Determining an originator brand will improve the operation of the PBS by delivering better value for money for PBS medicines through price disclosure 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.

 

 

Nikolai Tsyganov

Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Originator Brand) Amendment Determination 2021 (No. 6) 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 was enacted to address the need for updating the originator brand of a pharmaceutical item as it transitions from the F1 to the F2 formulary on the Pharmaceutical Benefits Scheme (PBS). The PBS is governed by the National Health Act 1953, which aims to provide affordable access to necessary and cost-effective medicines for Australians. The policy objective of this amendment is to facilitate the removal of originator brand data from price disclosure calculations in certain circumstances, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. By determining the originator brand, the amendment aims to potentially increase price disclosure-related price reductions, as originator brands often maintain higher prices than generic brands. This change is scheduled to take effect on 1 November 2021.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2021 (No. 6) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a pharmaceutical item for one drug that is new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary, effective from 1 November 2021. This amendment is made under the authority of the National Health Act 1953 and is necessary to implement the removal of originator brand data from price disclosure calculations as set out in the National Health (Pharmaceutical Benefits) Regulations 2017. This removal is expected to increase price disclosure-related price reductions, as originator brands often maintain higher prices than other brands. Consequently, the government price for the medicine would more closely reflect the prices at which generic brands are being sold, not the prices of all brands. This instrument applies to the pharmaceutical industry and specifically to entities involved in the supply and pricing of pharmaceutical items on the PBS. The geographic reach of this determination is national, as it pertains to the PBS, which is administered by the Commonwealth of Australia. There are no stated exclusions or exemptions in this amendment, and it directly applies to the drug aprepitant moving from F1 to F2 on 1 November 2021.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2021 (No. 6) (F2021L01490) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a pharmaceutical item for aprepitant, a drug moving from the F1 to the F2 formulary of the Pharmaceutical Benefits Scheme (PBS) on 1 November 2021 (subsection 99ADB(6B) of the National Health Act 1953). This determination is necessary to implement the removal of originator brand data from price disclosure calculations under the National Health (Pharmaceutical Benefits) Regulations 2017 (subsection 99ADB(6C) of the Act). This change is expected to increase price disclosure-related price reductions because originator brands generally maintain higher prices than other brands (subsection 33(3) of the Acts Interpretation Act 1901). The determination imposes an obligation on the parties involved to adhere to the provisions of the amended legislation. The originator brand of aprepitant is identified as the brand that was listed when the drug was on the F1 formulary. This identification process ensures that the originator brand is correctly established, which is critical for the application of price disclosure calculations under the PBS. The legislation includes provisions for offences and penalties, although specific details regarding civil or criminal consequences for breach are not explicitly stated in the text. The maximum penalties for breaches of the National Health Act 1953 or the National Health (Pharmaceutical Benefits) Regulations 2017 may apply, as these are general regulatory frameworks governing the PBS. These penalties can include fines and other sanctions as determined by the relevant authorities. The Act and Regulations provide the overarching legal framework within which this determination operates, ensuring compliance with broader health legislation. The amendment is designed to enhance the efficiency and effectiveness of the PBS by ensuring that price disclosure calculations more accurately reflect market prices. By determining the originator brand of aprepitant, the legislation aims to promote fairer pricing practices, which in turn benefit consumers by potentially reducing out-of-pocket costs for PBS-subsidised medicines. This amendment is compatible with human rights, as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health by ensuring affordable access to essential medicines.

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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.