National Health (Originator Brand) Amendment Determination 2017 (No. 8) (PB 98 of 2017)

Overview

The National Health (Originator Brand) Amendment Determination 2017 (No. 8) amends the National Health (Originator Brand) Determination 2015 to address the need for determining originator brands of pharmaceutical items for two drugs that were newly added to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 October 2017. This instrument is made under subsection 99ADB(6B) of the National Health Act 1953 by the Australian Parliament and aims to implement the removal of originator brand data from price disclosure calculations, as stipulated in the National Health (Pharmaceutical Benefits) Regulations 2017. This amendment is expected to potentially increase price disclosure-related price reductions for PBS medicines, as originator brands generally maintain higher prices compared to other brands. Consequently, this will lead to better value for money for PBS medicines and reduce out-of-pocket costs for consumers, thereby advancing the protection of human rights as it assists with the progressive realisation of the right to the highest attainable standard of physical and mental health. This legislative instrument is compatible with human rights, as it supports the advancement of the right to the highest attainable standard of physical and mental health by providing affordable access to necessary and cost-effective medicines through the PBS. Originator removal is a crucial step in improving the operation of the PBS, ensuring that the government price more accurately reflects the prices of generic brands of medicines in the market. By doing so, this legislative instrument contributes to the overall objective of the National Health Act 1953, which is to regulate the listing, prescribing, pricing, charging, and payment of subsidies for the supply of drugs and medicinal preparations as pharmaceutical benefits.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2017 (No. 8) applies to the determination of originator brands for specific pharmaceutical items that are new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary, specifically for the drugs dutasteride and hyoscine as they transition from F1 to F2 on 1 October 2017. This legislative instrument amends the National Health (Originator Brand) Determination 2015, which was concerned with establishing the originator brands of pharmaceutical items that had a drug on the F2 formulary. All drugs on F2 are subject to price disclosure, and this amendment is crucial for implementing the removal of originator brand data from price disclosure calculations under the National Health (Pharmaceutical Benefits) Regulations 2017. This removal is intended to increase price disclosure-related price reductions, as originator brands typically maintain higher prices than other brands. The amendment is necessary under subsection 99ADB(6B) of the National Health Act 1953, and the decision to determine these brands as originators was primarily based on their status as the listed brands of the drugs when they were first on the F1 or Combination Drug List (CDL). This instrument, effective from 1 December 2017, is a legislative instrument as defined by the Legislation Act 2003.

Key Provisions

The main operative sections of the National Health (Originator Brand) Amendment Determination 2017 (No. 8) (F2017L01550) pertain to the determination of originator brands for pharmaceutical items, specifically for the drugs dutasteride and hyoscine, which have moved to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 October 2017 (Schedule 1). This determination is crucial for implementing the originator removal process, which aims to increase price disclosure-related price reductions by basing the Government price on the prices of generic brands rather than originator brands, which typically have higher prices (subsection 99ADB(6C) of the National Health Act 1953). The criteria for determining the originator brands were based on whether these brands were listed when the drugs were on the F1 formulary or the Combination Drug List (subsection 85(6) of the Act). The Act imposes several obligations and requirements on the entities it governs. Firstly, it requires the Minister or delegate to determine originator brands based on whether the brand was on F1 or the Combination Drug List when it was first determined as a brand of pharmaceutical item. Secondly, it mandates that originator brands be listed when the drugs were on F1 or the Combination Drug List. These requirements ensure that the originator brand determination process is transparent and based on historical data, which aids in the accurate calculation of PBS prices and the implementation of the originator removal policy. Offences, penalties, or civil/criminal consequences for breach of this Act are not explicitly detailed in the explanatory statement. However, breaches of the National Health Act 1953 or its regulations could potentially lead to penalties under the relevant sections of the Act, which may include fines and other sanctions. The National Health (Pharmaceutical Benefits) Regulations 2017 provide the framework within which the Act operates, and any breaches of these regulations could result in penalties as outlined in those regulations. It is important to refer to the specific sections of the Act and the Regulations for detailed information on penalties and enforcement mechanisms. In summary, the National Health (Originator Brand) Amendment Determination 2017 (No. 8) establishes the originator brands for two drugs newly listed on the PBS F2 formulary, which is essential for the implementation of originator removal and the potential increase in price reductions. The determination process is governed by specific criteria and is necessary to ensure that the PBS operates efficiently and provides better value for money. While the explanatory statement does not detail the penalties for breaches, it is clear that adherence to the Act and its regulations is crucial for maintaining the integrity of the PBS and ensuring its objectives are met.