National Health (Weighted average disclosed price – April 2017 reduction day) Amendment Determination 2017 (No.1) (PB 12 of 2017)

Overview

The National Health (Weighted Average Disclosed Price – April 2017 Reduction Day) Amendment Determination 2017 (No.1) was enacted to address inaccuracies in the weighted average disclosed price (WADP) for specific pharmaceutical items listed in the National Health Act 1953. This legislative instrument, made by the Minister for Health under subsection 99ADB(4) of the Act, aims to correct the WADPs for pharmaceutical brands containing iron polymaltose complex by injection, sorbitol with sodium citrate and sodium lauryl sulfoacetate for rectal administration, ursodeoxycholic acid for oral administration, and zoledronic acid by injection. These amendments were necessitated by the discovery of incorrect data in the initial determinations for these drugs, which were identified following consultation with responsible persons. The corrected WADPs have been recalculated in accordance with the Act and the National Health (Pharmaceutical Benefits) Regulations 1960, ensuring that the pricing reflects accurate data and aligns with the policy objectives of the National Health Act. This instrument ensures that the Pharmaceutical Benefits Scheme remains fair and efficient by addressing discrepancies in the pricing of essential medications.

Scope and Application

The National Health (Weighted average disclosed price – April 2017 reduction day) Amendment Determination 2017 (No. 1) applies to the determination of the weighted average disclosed price (WADP) for specific brands of pharmaceutical items. The amendment pertains to brands containing iron polymaltose complex by injection, sorbitol with sodium citrate and sodium lauryl sulfoacetate for rectal administration, ursodeoxycholic acid for oral administration, and zoledronic acid by injection. This legislative instrument is made under subsection 99ADB(4) of the National Health Act 1953 and is effective across the Commonwealth of Australia. It amends the National Health (Weighted average disclosed price – April 2017 reduction day) Determination 2016, addressing incorrect data previously submitted by responsible persons, and inserting revised WADPs for the specified pharmaceutical items. The instrument excludes brands not specified in the amendment and relies on the Acts Interpretation Act 1901 for its authority to vary the previous determinations. The amendment takes effect on the day after it is registered on the Federal Register of Legislation.

Key Provisions

The main operative sections of the National Health (Weighted average disclosed price – April 2017 reduction day) Amendment Determination 2017 (No.1) (the Determination) are concerned with the adjustment of the weighted average disclosed price (WADP) for specific pharmaceutical brands, as per sections 99ADB(4) and 99ADH(1)(aa) of the National Health Act 1953. This Determination modifies the WADP for brands containing iron polymaltose complex, sorbitol with sodium citrate and sodium lauryl sulfoacetate, ursodeoxycholic acid, and zoledronic acid, reflecting corrected data submitted by responsible persons. These adjustments are detailed in Schedule 1 for brands of zoledronic acid, which continue to meet the criteria for an unadjusted price reduction of at least 10%, and in Schedule 2 for the other brands, where the unadjusted price reduction is less than 10%. The changes are effective as of the date the Determination is registered on the Federal Register of Legislation. The Determination imposes obligations on the parties involved, particularly the responsible persons for the pharmaceutical brands affected. These persons must submit accurate data concerning the WADPs for the brands in question. Any corrections to previously submitted data must be submitted in a timely manner to ensure that the WADPs are correctly calculated and adjusted. Responsible persons are also required to comply with the National Health (Pharmaceutical Benefits) Regulations 1960, which govern the determination and adjustment of WADPs. Failure to comply with the requirements set out in the Determination and the relevant regulations may result in civil or criminal consequences. While the Determination does not explicitly outline specific offences or penalties, breaches of the National Health Act 1953 or the Regulations may attract penalties under those Acts. For example, under the National Health Act, penalties may include fines for misleading or deceptive conduct or failure to comply with the Act, and in more severe cases, criminal penalties may apply. The exact penalties depend on the nature and severity of the breach, as well as the specific provisions of the relevant legislation.