National Health (April 2020 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2020
National Health Act 1953
I, THEA DANIEL, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this determination under subsection 99ACF(3) of the National Health Act 1953.
Dated 30 March 2020
THEA DANIEL
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health
1 Name of Determination
This instrument is the National Health (April 2020 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2020.
2 Commencement
This instrument commences on 1 April 2020.
3 Definition
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.
price reduction day has the same meaning as in section 99ACL of the Act.
4 Authority
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 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 3 or 4 of the table in subsection 99ACF(1) of the Act, as appropriate, in relation to the price 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 |
1 | High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral liquid 200 mL, 32 (KetoCal 4:1 LQ) | Oral | KetoCal 4:1 LQ |
2 | High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral powder 300 g (KetoCal 3:1) | Oral | KetoCal 3:1 |
3 | High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate | Oral powder 300 g (KetoCal 4:1) | Oral | KetoCal 4:1 |
4 | Iron sucrose | Concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL | Injection | Venofer |
Overview
The National Health (April 2020 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2020, enacted under the National Health Act 1953, was introduced to address the issue of pharmaceutical pricing in Australia. This determination was made by Thea Daniel, an Assistant Secretary from the Department of Health, on 30 March 2020. The objective of this legislation was to exercise ministerial discretion concerning the statutory price reduction of certain pharmaceutical items on a designated price reduction day, as outlined in the Act. By specifying which brands of pharmaceutical items would not undergo a price reduction, the determination aims to ensure that certain high-need medications remain affordable for consumers, thereby maintaining access to essential treatments.
Scope and Application
The National Health (April 2020 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2020 applies to the approved ex-manufacturer price of specific brands of pharmaceutical items listed in Schedule 1 of the instrument. The determination is made under subsection 99ACF(3) of the National Health Act 1953 and specifies that the ex-manufacturer prices of these particular pharmaceutical items will not be reduced in accordance with certain provisions of the Act, effective from the price reduction day. The geographic reach of this determination is national, as it is made under the authority of the Commonwealth. The exclusions are explicitly outlined in Schedule 1, which details the brands and forms of pharmaceutical items that are not subject to the price reduction. This determination does not create new legislation but rather exercises discretion within the existing framework of the National Health Act 1953.
Key Provisions
The National Health (April 2020 Anniversary statutory price reduction) (Exercise of Ministerial discretion) Determination 2020 (the "Determination") under the National Health Act 1953, specifies that certain pharmaceutical items will not undergo a statutory price reduction on the price reduction day. According to section 5 of the Determination, the approved ex-manufacturer price of specific brands of pharmaceutical items listed in Schedule 1 will not be reduced. These items include various forms of high fat formulas with vitamins, minerals, and trace elements, low in protein and carbohydrate, such as KetoCal 4:1 LQ and KetoCal 3:1, and Iron sucrose concentrate for solution for infusion.
The Determination imposes obligations on the pharmaceutical manufacturers and suppliers to ensure that the prices of the specified pharmaceutical items remain unchanged as per the ministerial discretion exercised. These entities must comply with the provisions of the Determination and the National Health Act 1953, which includes maintaining the approved ex-manufacturer prices of the designated items. Furthermore, healthcare providers and pharmacies must adhere to the specified prices when dispensing these pharmaceutical items to patients.
Failure to comply with the provisions of the Determination may result in civil or criminal consequences. According to the National Health Act 1953, penalties may be imposed for breaches of the Act or any determination made under it. The maximum penalties for contraventions of the Act may include fines and, in some cases, imprisonment. The exact penalties depend on the nature and severity of the breach, as well as the specific provisions of the National Health Act 1953. It is essential for all parties involved, including manufacturers, suppliers, healthcare providers, and pharmacies, to be aware of their obligations under the Determination and the Act to avoid any potential penalties or legal consequences.