PB 37 of 2024
National Health (April 2024 Price Reductions) (Exercise of Ministerial discretion) Determination (No.2) 2024
National Health Act 1953
I, NIKOLAI TSYGANOV, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged, delegate of the Minister for Health and Aged Care make this determination under subsection 99ACF(3) of the National Health Act 1953.
Dated 27 March 2024
NIKOLAI TSYGANOV
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Health Resourcing Group
Department of Health and Aged Care
(1) This instrument is the National Health (April 2024 Price Reductions) (Exercise of Ministerial discretion) Determination (No.2) 2024.
(2) This instrument may also be cited as PB 37 of 2024.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information |
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | The day this instrument is registered. | |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
Note: A number of expressions used in this instrument are defined in Part VII the Act.
In this instrument:
Act means the National Health Act 1953.
reduction day in this instrument refers to 1 April 2024.
This instrument is made under subsection 99ACF(3) of the Act.
5 Brand of pharmaceutical item not subject to a price reduction
I determine, under paragraph 99ACF(3)(a) of the Act, that the approved ex-manufacturer price, and each of the claimed prices (if applicable) of each brand of pharmaceutical item specified in column 2 as an item in the table in Schedule 1 is not reduced under a provision mentioned in item 2A in subsection 99ACF(1) of the Act, as appropriate, in relation to the reduction day.
Schedule 1— Brands of pharmaceutical items with approved ex-manufacturer price not reduced
Column 1 | Column 2 |
Item | Brand of Pharmaceutical Item |
| Drug | Form | Manner of administration | Brand(s) |
1 | Dulaglutide | Injection 1.5 mg in 0.5 mL single dose pre-filled pen | Injection | Trulicity |
2 | Trifluridine with tipiracil | Tablet containing 15 mg trifluridine with 6.14 mg tipiracil (as hydrochloride) | Oral | Lonsurf 15/6.14 |
3 | Trifluridine with tipiracil | Tablet containing 20 mg trifluridine with 8.19 mg tipiracil (as hydrochloride) | Oral | Lonsurf 20/8.19 |
Overview
The National Health (April 2024 Price Reductions) (Exercise of Ministerial discretion) Determination (No.2) 2024, known as PB 37 of 2024, was enacted under subsection 99ACF(3) of the National Health Act 1953. This legislation was introduced to exercise the Minister for Health and Aged Care's discretion over the reduction of prices for certain pharmaceutical items, as mandated by the Act. The determination specifies brands of pharmaceutical items that are exempt from the price reductions scheduled for 1 April 2024, aiming to ensure that the pricing policies align with the overall objectives of the National Health Act. The policy objective is to provide a clear framework for the application of price reductions while safeguarding the interests of certain pharmaceutical brands that require special consideration.
Scope and Application
The National Health (April 2024 Price Reductions) (Exercise of Ministerial discretion) Determination (No.2) 2024 applies to specific brands of pharmaceutical items listed in Schedule 1, where the approved ex-manufacturer price and claimed prices of these items will not be reduced on the reduction day, which is 1 April 2024. This determination is made under the authority of subsection 99ACF(3) of the National Health Act 1953, and it affects the pricing of certain pharmaceutical products. The Act and the determination have a national jurisdictional reach across Australia, impacting entities involved in the manufacture and supply of these pharmaceutical products. The determination specifies certain brands that are exempt from the price reductions applicable to other pharmaceutical items, thus directly affecting the pharmaceutical industry and potentially the consumers who rely on these medications. Any subordinate instruments or regulations that might further detail or expand upon the application of this determination are not explicitly mentioned in the provided text.
Key Provisions
The main operative sections of the National Health (April 2024 Price Reductions) (Exercise of Ministerial discretion) Determination (No.2) 2024 are detailed in sections 1 to 5. Section 1 provides the name and citation of the determination, indicating that it is also referred to as PB 37 of 2024. Section 2 outlines the commencement of the provisions, which is the day the instrument is registered. Section 3 includes definitions pertinent to the instrument, with "Act" referring to the National Health Act 1953, and "reduction day" specified as 1 April 2024. Section 4 confirms the authority under which the instrument is made, citing subsection 99ACF(3) of the Act. Section 5 specifies the brands of pharmaceutical items not subject to a price reduction, with details provided in Schedule 1.
The obligations and requirements imposed by the Act primarily involve the exercise of ministerial discretion regarding pharmaceutical pricing. The Minister, or their delegate, is required to determine which brands of pharmaceutical items are exempt from price reductions as specified in the instrument. This determination must be made in accordance with the provisions outlined in the Act, particularly under subsection 99ACF(3) and item 2A of subsection 99ACF(1). The determination must identify specific pharmaceutical items, their form, and manner of administration, ensuring that these items are not subject to the price reduction on the reduction day.
Under this determination, any breach of the ministerial discretion exercised would result in significant consequences. Although specific offences, penalties, or civil/criminal consequences are not detailed within the text provided, it is reasonable to infer that non-compliance with the ministerial determination could lead to legal action. Such actions may include enforcement proceedings under the National Health Act 1953, with penalties for non-compliance potentially including fines or other sanctions as prescribed by the Act. The exact penalties would depend on the specific provisions of the National Health Act and any relevant regulations or guidelines. The determination's authority and the serious nature of pharmaceutical pricing suggest that any breaches could have substantial implications for the parties involved.