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National Health (Weighted average disclosed price - interim supplementary disclosure cycle) Determination 2012 (No. PB 58 of 2012)

National Health (Weighted average disclosed price - interim supplementary disclosure cycle) Determination 2012 (No. PB 58 of 2012)

Administered by Department of Health, Disability and Ageing

Legislation au F2012L01731 Not in force Legislative Instrument

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PB 58 of 2012

National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012

as amended

made under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the

National Health Act 1953

This compilation was prepared on 5 November 2012
taking into account amendments up to PB 98 of 2012

Prepared by the Office of Parliamentary Counsel, Canberra

Contents

1 Name of Determination [see Note 1]

2 Commencement [see Note 1]

3 Definitions

4 Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is at least 10%

5 Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is less than 10%

6 Adjusted approved ex‑manufacturer price for brands of pharmaceutical items – unadjusted price reduction is at least 10%

7 Adjusted approved price to pharmacists for brands of pharmaceutical items – unadjusted price reduction is at least 10%

8 Reduction Day

Schedule 1 Brands of pharmaceutical items – unadjusted price reduction is at least 10%

Schedule 2 Brands of pharmaceutical items – unadjusted price reduction is less than 10%

Notes

1 Name of Determination [see Note 1]

(1) This Determination is the National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012.

(2) This Determination may also be cited as PB 58 of 2012.

2 Commencement [see Note 1]

This Determination commences on the day after it is registered.

3 Definitions

In this Determination:

Act means the National Health Act 1953.

adjusted approved ex‑manufacturer price has the same meaning as in subsection 99ADB(1) of the Act.

adjusted approved price to pharmacists has the same meaning as in subsection 99ADB(1) of the Act.

interim supplementary disclosure cycle has the same meaning as paragraph 37EB (2) (b), of the National Health (Pharmaceutical Benefits) Regulations 1960.

unadjusted price reduction has the same meaning as in subsection 99ADB(1) of the Act.

weighted average disclosed price has the same meaning as in subsection 99ADB(1) of the Act.

4 Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is at least 10%

For subsection 99ADB(4) of the Act, the weighted average disclosed price specified in column 3 of an item in Schedule 1 is the weighted average disclosed price for the brand of pharmaceutical item specified in column 2 of the same item in Schedule 1.

5 Weighted average disclosed price for brands of pharmaceutical items – unadjusted price reduction is less than 10%

For subsection 99ADB(4) of the Act, the weighted average disclosed price specified in column 3 of an item in Schedule 2 is the weighted average disclosed price for the brand of pharmaceutical item specified in column 2 of the same item in Schedule 2.

6 Adjusted approved ex‑manufacturer price for brands of pharmaceutical items – unadjusted price reduction is at least 10%

For paragraph 99ADB(4) of the Act, the adjusted approved ex‑manufacturer price for a brand of pharmaceutical item specified in column 2 of Schedule 1 is an amount equal to the amount of the weighted average disclosed price of that brand of pharmaceutical item determined under section 4 of this instrument.

7 Adjusted approved price to pharmacists for brands of pharmaceutical items – unadjusted price reduction is at least 10%

For paragraph 99ADB(4) of the Act, the adjusted approved price to pharmacists specified in column 4 of an item in Schedule 1 is the adjusted approved price to pharmacists for the brand of pharmaceutical item specified in column 2 of the same item in Schedule 1.

8 Reduction Day

For paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item in the interim supplementary disclosure cycle with a data collection period ending at the end of 31 May 2012 has a reduction day of 1 December 2012.

Schedule 1 Brands of pharmaceutical items – unadjusted price reduction is at least 10%

Column 1	Column 2				Column 3	Column 4
Item	Brand of Pharmaceutical Item				Weighted average disclosed price	Adjusted approved price to pharmacists
	Listed Drug	Form	Manner of administration	Brand
2	Docetaxel	Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent	Injection	Taxotere	267.72
3	Docetaxel	Powder for I.V. infusion 20 mg with solvent	Injection	Docetaxel SUN	66.80
4	Docetaxel	Powder for I.V. infusion 80 mg with solvent	Injection	Docetaxel SUN	267.72
5	Docetaxel	Solution concentrate for I.V. infusion 140 mg in 7 mL	Injection	Oncotaxel 140	466.48
6	Docetaxel	Solution concentrate for I.V. infusion 160 mg in 16 mL	Injection	DBL Docetaxel Concentrated Injection	535.44
7	Docetaxel	Solution concentrate for I.V. infusion 20 mg in 1 mL	Injection	Oncotaxel 20	66.80
8	Docetaxel	Solution concentrate for I.V. infusion 20 mg in 1 mL	Injection	Taxotere	66.80
9	Docetaxel	Solution concentrate for I.V. infusion 20 mg in 2 mL	Injection	DBL Docetaxel Concentrated Injection	66.80
10	Docetaxel	Solution concentrate for I.V. infusion 20 mg in 2 mL	Injection	Docetaxel Ebewe	66.80
11	Docetaxel	Solution concentrate for I.V. infusion 20 mg in 2 mL	Injection	Docetaxel Sandoz	66.80
12	Docetaxel	Solution concentrate for I.V. infusion 80 mg in 4 mL	Injection	Oncotaxel 80	267.72
13	Docetaxel	Solution concentrate for I.V. infusion 80 mg in 4 mL	Injection	Taxotere	267.72
14	Docetaxel	Solution concentrate for I.V. infusion 80 mg in 8 mL	Injection	DBL Docetaxel Concentrated Injection	267.72
15	Docetaxel	Solution concentrate for I.V. infusion 80 mg in 8 mL	Injection	Docetaxel Ebewe	267.72
16	Docetaxel	Solution concentrate for I.V. infusion 80 mg in 8 mL	Injection	Docetaxel Sandoz	267.72
17	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Acpio 15	27.74	29.83
18	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Actos	27.74	29.83
19	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	APOTEX‑Pioglitazone	27.74	29.83
20	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Chem mart Pioglitazone	27.74	29.83
21	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Pharmacor Pioglitazone 15	27.74	29.83
22	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Pioglitazone generichealth 15	27.74	29.83
23	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Pioglitazone Sandoz	27.74	29.83
24	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Pioglitazone‑GA	27.74	29.83
25	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Pizaccord	27.74	29.83
25A	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Prioten 15	27.74	29.83
26	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Terry White Chemists Pioglitazone	27.74	29.83
27	Pioglitazone	Tablet 15 mg (as hydrochloride)	Oral	Vexazone	27.74	29.83
28	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Acpio 30	42.67	45.88
29	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Actos	42.67	45.88
30	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	APOTEX‑Pioglitazone	42.67	45.88
31	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Chem mart Pioglitazone	42.67	45.88
32	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Pharmacor Pioglitazone 30	42.67	45.88
33	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Pioglitazone generichealth 30	42.67	45.88
34	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Pioglitazone Sandoz	42.67	45.88
35	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Pioglitazone‑GA	42.67	45.88
36	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Pizaccord	42.67	45.88
36A	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Prioten 30	42.67	45.88
37	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Terry White Chemists Pioglitazone	42.67	45.88
38	Pioglitazone	Tablet 30 mg (as hydrochloride)	Oral	Vexazone	42.67	45.88
39	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Acpio 45	55.48	59.65
40	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Actos	55.48	59.65
41	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	APOTEX‑Pioglitazone	55.48	59.65
42	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Chem mart Pioglitazone	55.48	59.65
43	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Pharmacor Pioglitazone 45	55.48	59.65
44	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Pioglitazone generichealth 45	55.48	59.65
45	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Pioglitazone Sandoz	55.48	59.65
46	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Pioglitazone‑GA	55.48	59.65
47	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Pizaccord	55.48	59.65
47A	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Prioten 45	55.48	59.65
48	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Terry White Chemists Pioglitazone	55.48	59.65
49	Pioglitazone	Tablet 45 mg (as hydrochloride)	Oral	Vexazone	55.48	59.65
50	Risedronic Acid	Tablet (enteric coated) containing risedronate sodium 35 mg	Oral	Actonel EC	25.49
51	Risedronic Acid	Tablet containing risedronate sodium 150 mg	Oral	Actonel Once-a-Month	27.62
52	Risedronic Acid	Tablet containing risedronate sodium 30 mg	Oral	Actonel	168.36
53	Risedronic Acid	Tablet containing risedronate sodium 35 mg	Oral	Acris Once-a-Week	25.49
54	Risedronic Acid	Tablet containing risedronate sodium 35 mg	Oral	APO-Risedronate	25.49
55	Risedronic Acid	Tablet containing risedronate sodium 35 mg	Oral	Chem mart Risedronate	25.49
56	Risedronic Acid	Tablet containing risedronate sodium 35 mg	Oral	Risedro once a week	25.49
57	Risedronic Acid	Tablet containing risedronate sodium 35 mg	Oral	Risedronate Sandoz	25.49
58	Risedronic Acid	Tablet containing risedronate sodium 35 mg	Oral	Risedronate-GA	25.49
59	Risedronic Acid	Tablet containing risedronate sodium 35 mg	Oral	Terry White Chemists Risedronate	25.49
60	Risedronic Acid	Tablet containing risedronate sodium 5 mg	Oral	Actonel	25.49

Schedule 2 Brands of pharmaceutical items – unadjusted price reduction is less than 10%

Column 1	Column 2				Column 3
Item	Brand of Pharmaceutical Item				Weighted average disclosed price
	Listed Drug	Form	Manner of administration	Brand
1	Perindopril with amlodipine	Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)	Oral	Coveram	27.36
2	Perindopril with amlodipine	Tablet containing 10 mg perindopril arginine with 10 mg amlodipine (as besylate)	Oral	Reaptan 10/10	27.36
3	Perindopril with amlodipine	Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)	Oral	Coveram	21.45
4	Perindopril with amlodipine	Tablet containing 10 mg perindopril arginine with 5 mg amlodipine (as besylate)	Oral	Reaptan 10/5	21.45
5	Perindopril with amlodipine	Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)	Oral	Coveram	22.67
6	Perindopril with amlodipine	Tablet containing 5 mg perindopril arginine with 10 mg amlodipine (as besylate)	Oral	Reaptan 5/10	22.67
7	Perindopril with amlodipine	Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)	Oral	Coveram	16.73
8	Perindopril with amlodipine	Tablet containing 5 mg perindopril arginine with 5 mg amlodipine (as besylate)	Oral	Reaptan 5/5	16.73

Notes to the National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012 (PB 58 of 2012)

Note 1

The National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012 (PB 58 of 2012) (in force under subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the National Health Act 1953) as shown in this compilation is amended as indicated in the Tables below.

Table of Instruments

Title	Date of FRLI registration	Date of commencement	Application, saving or transitional provisions
PB 58 of 2012	22 Aug 2012 (see F2012L01731)	23 Aug 2012
PB 70 of 2012	21 Sept 2012 (see F2012L01907)	22 Sept 2012	—
PB 98 of 2012	5 Nov 2012 (see F2012L02147)	5 Nov 2012	—

Table of Amendments

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected	How affected
Schedule 1
Schedule 1............	am. PB 70 and 98 of 2012

Overview

The National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012 was introduced under the National Health Act 1953, and was enacted to address the need for transparency and fairness in the pricing of pharmaceutical items listed on the Pharmaceutical Benefits Scheme (PBS). The determination was made by the Parliament of Australia, and its primary policy objective is to ensure that the prices of pharmaceutical items are accurately disclosed and adjusted where necessary to reflect any price reductions. This legislative instrument aims to maintain the integrity of the PBS by providing clear guidelines on how to calculate and apply the weighted average disclosed price for pharmaceutical brands, particularly in cases where there are significant price reductions. By setting out these specific calculations and adjustments, the Determination supports the broader goal of ensuring affordable access to essential medicines for Australians.

Scope and Application

The National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012 is a legislative instrument made under the National Health Act 1953. It applies to brands of pharmaceutical items listed in Schedules 1 and 2, which are subject to an unadjusted price reduction of at least 10% and less than 10%, respectively. The determination sets the weighted average disclosed price and the adjusted approved prices for these pharmaceutical items, which are primarily used for the Pharmaceutical Benefits Scheme (PBS). The determination is applicable across Australia as it is a Commonwealth legislation. The application of the determination can be extended or restricted through subordinate instruments. There are no explicit exclusions mentioned in the determination, but the applicability is limited to the specified pharmaceutical brands and their respective price reductions as listed in the schedules.

Key Provisions

The main operative sections of the National Health (Weighted average disclosed price – interim supplementary disclosure cycle) Determination 2012 (PB 58 of 2012) provide specific weighted average disclosed prices for brands of pharmaceutical items, particularly those with an unadjusted price reduction of at least 10% or less than 10% (sections 4 and 5). It also sets out the adjusted approved ex-manufacturer prices for brands with at least a 10% unadjusted price reduction (section 6), and the adjusted approved prices to pharmacists for brands with at least a 10% unadjusted price reduction (section 7). The Determination further specifies the reduction day for brands in the interim supplementary disclosure cycle (section 8). The schedules list the specific brands, their forms, manners of administration, and the corresponding prices (Schedules 1 and 2). The obligations imposed by the Determination require pharmaceutical companies to adhere to the specified weighted average disclosed prices for their brands, particularly those undergoing significant price reductions. These companies must ensure that their pricing information aligns with the details provided in the schedules of the Determination. For brands with at least a 10% unadjusted price reduction, the Determination mandates the calculation of adjusted approved ex-manufacturer and approved prices to pharmacists, as outlined in the respective sections. Any breaches of the obligations set forth in the Determination may lead to civil or criminal consequences, depending on the nature and severity of the breach. The penalties for such breaches are not explicitly stated within the Determination itself but would typically be governed by the National Health Act 1953 and other relevant legislative provisions. These penalties could encompass fines, corrective actions, or other regulatory measures deemed appropriate by the relevant authorities.

Area of Law: Health Law; Pharmaceutical Law
Instrument: Legislative Instrument
Concepts: Definitions & Interpretation; Reporting & Disclosure Obligations; Regulatory Standards

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

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