National Health (Originator Brand) Amendment Determination 2019 (No. 9) (PB 99 of 2019)

Overview

The National Health (Originator Brand) Amendment Determination 2019 (No. 9) amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a pharmaceutical item for the drug sevelamer, which is new to the Pharmaceutical Benefits Scheme (PBS) F2 formulary on 1 December 2019. This amendment 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, as outlined in the National Health (Pharmaceutical Benefits) Regulations 2017. This change is expected to result in increased price reductions within the PBS, as originator brands typically maintain higher prices than generic brands. The amendment is intended to ensure the PBS continues to provide timely, reliable, and affordable access to necessary and cost-effective medicines by enhancing value for money through better pricing mechanisms. The determination of originator brands is based on the criteria that the brand was listed on the F1 formulary or the Combination Drug List when it was first recognised under the Act. This legislative instrument is compatible with human rights, particularly the right to the highest attainable standard of physical and mental health, by facilitating more affordable access to essential medicines through the PBS.

Scope and Application

The National Health (Originator Brand) Amendment Determination 2019 (No. 9) is a legislative instrument made under the National Health Act 1953, which governs the operation of the Pharmaceutical Benefits Scheme (PBS). This instrument amends the National Health (Originator Brand) Determination 2015 to determine the originator brand of a specific pharmaceutical item, sevelamer, for the purposes of PBS pricing and subsidies. It applies to the pharmaceutical industry, particularly entities that manufacture and supply sevelamer or similar drugs listed under the F2 formulary, which are subject to price disclosure. The determination is crucial for the implementation of originator removal, a policy under the National Health (Pharmaceutical Benefits) Regulations 2017, where originator brand data is excluded from price disclosure calculations. This change is expected to lead to lower prices and thus reduce out-of-pocket expenses for consumers. The Act and its regulations have a national reach, applying across Australia, and this amendment applies specifically to the drug sevelamer as it transitions from the F1 formulary to the F2 formulary on 1 December 2019. There are no specific exclusions or exemptions noted in the determination, but the application of the originator removal policy is contingent on meeting the criteria set out in the Regulations. The instrument is compatible with human rights as it aims to enhance access to affordable and cost-effective medicines under the PBS.

Key Provisions

The main operative sections of the National Health (Originator Brand) Amendment Determination 2019 (No. 9) (F2019L01512) pertain to the amendment of the National Health (Originator Brand) Determination 2015. Specifically, section 2(1) of this amending instrument determines the originator brand for a pharmaceutical item concerning the drug sevelamer, which transitions from the F1 formulary to the F2 formulary of the Pharmaceutical Benefits Scheme (PBS) on 1 December 2019. This amendment aligns with subsection 99ADB(6B) of the National Health Act 1953 and is based on the criteria outlined in subsection 99ADB(6C) of the Act, which considers whether the brand was on F1 or the Combination Drug List (CDL) when it was first determined as a brand of pharmaceutical item under subsection 85(6) of the Act. The amendment is set out in Schedule 1 of the instrument. The obligations and requirements imposed by this Act primarily involve the determination of the originator brand of a pharmaceutical item, specifically for the drug sevelamer as it moves from the F1 formulary to the F2 formulary. The Act mandates that the determination be made based on whether the brand was listed when it was first identified as a pharmaceutical item under the relevant subsections of the Act. Additionally, the Act requires that the determination be consistent with the criteria established under the National Health (Pharmaceutical Benefits) Regulations 2017, particularly concerning the originator removal for price disclosure calculations. This ensures that the pricing of the drug reflects the prices at which generic brands are sold, rather than the higher prices typically maintained by originator brands. The legislation also outlines consequences for non-compliance with its provisions. While the specific penalties for breaches are not detailed in the explanatory statement, it is implied that non-compliance with the Act could lead to legal repercussions. Such consequences might include administrative actions, fines, or other penalties as prescribed by the relevant laws governing the PBS and the National Health Act 1953. The exact penalties would depend on the nature and severity of the breach, and could potentially involve civil or criminal liabilities as stipulated by the applicable regulatory frameworks. It is crucial for entities and parties governed by this Act to adhere to the determinations and requirements set forth to avoid any adverse outcomes.