National Health (Originator Brand) Amendment Determination 2018 (No. 6) (PB 88 of 2018)

Overview

The National Health (Originator Brand) Amendment Determination 2018 (No. 6) is an amendment to the National Health (Originator Brand) Determination 2015, made under subsection 99ADB(6B) of the National Health Act 1953. Enacted by the Australian Parliament, this legislation aims to address the issue of originator brand data in price disclosure calculations for pharmaceutical items on the Pharmaceutical Benefits Scheme (PBS) F2 formulary. The Act was introduced to ensure that the originator brand determination aligns with the criteria set out in the National Health (Pharmaceutical Benefits) Regulations 2017, thereby potentially increasing price disclosure-related price reductions, which in turn assists in reducing out-of-pocket costs for consumers by reflecting more accurately the prices at which generic brands of the medicine are being sold in the market. The policy objective of this amendment is to support the progressive realisation of the right to the highest attainable standard of physical and mental health as outlined in the International Covenant on Economic, Social and Cultural Rights. By determining the originator brand of a pharmaceutical item for drugs moving from the F1 formulary to the F2 formulary, and implementing the removal of originator brand data from price disclosure calculations, the legislation seeks to enhance the affordability and accessibility of necessary medicines for Australians under the PBS. This amendment ensures that the PBS continues to operate efficiently, providing cost-effective and timely access to essential medicines.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2018 (No. 6) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a pharmaceutical item for one drug, ivabradine, which has been newly added to the Pharmaceutical Benefits Scheme (PBS) F2 formulary. This determination is made pursuant to subsection 99ADB(6B) of the National Health Act 1953 and is necessary to implement the removal of originator brand data from price disclosure calculations under certain circumstances as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. The amendment is intended to increase price disclosure-related price reductions for PBS medicines, as originator brands tend to maintain higher prices than generic brands, thereby potentially reducing out-of-pocket costs for consumers. The amendment applies to pharmaceutical entities involved in the supply of ivabradine under the PBS, and it operates nationally across Australia. There are no stated exclusions or exemptions in this particular determination, although broader exclusions and exemptions may apply under the Act and the Regulations.

Key Provisions

The main operative sections of the National Health (Originator Brand) Amendment Determination 2018 (No. 6) involve the amendment of the National Health (Originator Brand) Determination 2015 (section 99ADB(6B)). This amendment specifies the originator brand for a pharmaceutical item, in this case, the drug ivabradine, which has been moved from the F1 formulary to the F2 formulary of the Pharmaceutical Benefits Scheme (PBS) on 1 October 2018 (subsection 99ADB(6C)). The criteria for determining the originator brand are that the brand must have been listed on the F1 formulary or the Combination Drug List (CDL) when it was first determined as a brand of pharmaceutical item (subsection 85(6)). This amendment ensures that the originator brand data is correctly identified and utilized in price disclosure calculations. The Act imposes specific obligations on the parties involved, primarily the Minister or their delegate, who must consider whether the brand was on the F1 or CDL when it was first determined as a brand of pharmaceutical item under subsection 85(6) of the National Health Act 1953. The criteria for determining the originator brand focus on whether the brand was the listed brand of the drug when it was on the F1 or CDL. This requirement ensures that the correct brand is identified as the originator for the purposes of price disclosure and potential originator brand removal, which can lead to increased price reductions within the PBS. There are no direct offences, penalties, or civil/criminal consequences specified in the amending instrument for breaches of the provisions. However, the overarching National Health Act 1953 and the National Health (Pharmaceutical Benefits) Regulations 2017 contain provisions that may lead to penalties for non-compliance with the PBS regulations and requirements. These penalties can include fines and other civil or administrative actions, depending on the nature and severity of the breach. The precise penalties would be determined by the relevant sections of the overarching legislation and the specific circumstances of the breach. The amendments aim to ensure compliance with the requirements for determining originator brands and the potential benefits of originator removal in increasing price reductions and reducing out-of-pocket costs for consumers.