National Health (Originator Brand) Amendment Determination 2015 (No. 2) (PB 127 of 2015)

Overview

The National Health (Originator Brand) Amendment Determination 2015 (No. 2) was enacted to amend the National Health (Originator Brand) Determination 2015, which was made under the National Health Act 1953. The primary purpose of this legislative instrument is to determine the originator brand of a pharmaceutical item for a specific drug, pemetrexed, which is transitioning from the F1 to F2 formulary on 1 January 2016. This amendment is necessary to implement the removal of originator brand data from price disclosure calculations as outlined in the National Health (Pharmaceutical Benefits) Regulations 1960. The objective is to potentially increase price reductions in the Pharmaceutical Benefits Scheme (PBS) by ensuring that the government price more closely reflects the prices of generic brands rather than originator brands, which typically maintain higher prices. The determination was made based on the drug's PBS listing history and the criteria set out in the Principal Instrument. The National Health (Originator Brand) Amendment Determination 2015 (No. 2) was enacted by the Australian Government and 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 removing originator brand data from price disclosure calculations, the amendment aims to improve the operation of the PBS, delivering better value for money and reducing out-of-pocket costs for consumers. This legislative instrument was developed in accordance with the Acts Interpretation Act 1901 and the Legislative Instruments Act 2003, and it is compatible with the human rights and freedoms recognised in the international instruments listed in the Human Rights (Parliamentary Scrutiny) Act 2011.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2015 (No. 2) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of pharmaceutical items for one drug that is new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary as of 1 January 2016. This instrument applies to pharmaceutical items that meet the criteria for being classified under the F2 formulary, which includes drugs that have moved from the F1 formulary or the single brand Combination Drug List. All drugs on the F2 formulary are subject to price disclosure, and the removal of originator brand data from price disclosure calculations is expected to potentially increase price reductions for PBS medicines, ultimately reducing out-of-pocket costs for consumers. This legislative instrument is made under subsection 99ADB(6B) of the National Health Act 1953 and operates nationally in Australia. The instrument is subject to the National Health (Pharmaceutical Benefits) Regulations 1960, which prescribe matters and set out details in relation to the operation of the PBS. This legislative instrument is compatible with human rights as it assists in the progressive realisation of the right to the highest attainable standard of physical and mental health by providing subsidised access to medicines for Australians.

Key Provisions

The National Health (Originator Brand) Amendment Determination 2015 (No. 2) amends the National Health (Originator Brand) Determination 2015 to establish the originator brand of a pharmaceutical item for a specific drug, pemetrexed, effective from 1 January 2016 (s. 2). This amendment is crucial for implementing changes in price disclosure calculations for the Pharmaceutical Benefits Scheme (PBS) as outlined in the National Health (Pharmaceutical Benefits) Regulations 1960. By determining the originator brand, the amendment seeks to enhance price transparency and potentially lower costs for consumers as the removal of originator brand data from these calculations may result in increased price reductions for PBS-listed medicines. The Act imposes obligations on the entities involved, primarily focusing on the accurate determination of the originator brand for pharmaceutical items. The determination process relies on several criteria, including the PBS listing history of the brand and its availability on the PBS before the drug moved to the F2 formulary (s. 3). The drug pemetrexed, which is the subject of this amendment, must meet these criteria to qualify for the originator brand status. The criteria ensure that the brand recognised as the originator was already listed on the PBS when the drug was on the F1 formulary prior to its transfer to the F2 formulary. Breaches of the requirements set out in this amendment could lead to legal consequences, although specific penalties are not detailed within the text. Under the National Health Act 1953, violations of the provisions concerning the PBS can result in various penalties, including fines and other civil or criminal sanctions. These penalties aim to enforce compliance with the Act and ensure that the PBS operates effectively and efficiently, ultimately benefiting consumers by providing affordable access to necessary medicines. In summary, this legislative instrument is designed to amend the National Health (Originator Brand) Determination 2015 to accurately determine the originator brand for pemetrexed, a drug moving to the PBS F2 formulary from 1 January 2016. This determination is necessary for implementing price disclosure changes that could lead to reduced costs for consumers. The Act imposes clear criteria and obligations for determining the originator brand, with potential legal consequences for non-compliance. The amendment aligns with human rights by enhancing the PBS's ability to provide affordable access to essential medicines, thereby advancing the right to the highest attainable standard of health.