{"id":"F2010L02534","name":"National Health Act 1953 - Determination made pursuant to subsections 99ADB(4) and 99ADB(5) (No. PB 43 of 2010)","slug":"national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-43-of-","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":84470,"registerId":"commonwealth-F2010L02534-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health Act 1953 - Determination made pursuant to subsections 99ADB(4) and 99ADB(5) (No. PB 43 of 2010)","content":"![](image.001.png)\n\nCOMMONWEALTH OF AUSTRALIA\n\nInstrument number PB 43 of 2010\n\nDetermination made pursuant to subsections 99ADB(4) and 99ADB(5) of the National Health Act 1953\n\nData collection period from 1 January 2009 to 31 December 2009 (inclusive)\n\nI, FELICITY MCNEILL, delegate of the Minister for Health and Ageing:\n\nREVOKE the determination made under section 99ADB of the National Health Act 1953 (“the Act”) on 30 July 2009 (as amended) (“PB 74 of 2009”).\n\nDETERMINE pursuant to subsection 99ADB(4) of the Act and in accordance with the National Health (Pharmaceutical Benefits) Regulations 1960 (“the Regulations”), that 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.\n\nDETERMINE pursuant to subsection 99ADB(5) of the Act, in accordance with the Regulations, that 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.\n\nThis instrument commences on the day after registration on the Federal Register of Legislative Instruments.\n\nDated 22 September 2010\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nFelicity McNeill\n\nAssistant Secretary\n\nPharmaceutical Evaluation Branch\n\nDepartment of Health and Ageing\n\nSchedule 1\n\n```html\n

Column 1

Column 2

Column 3

Item

Brand of Pharmaceutical Item

Weighted average disclosed price

Listed Drug

Form

Manner of administration

Brand

1

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendrobell 70mg

$25.04

2

Cisplatin

I.V. injection 100 mg in 100 mL

Injection

Pfizer Australia Pty Ltd

$26.98

3

Fluconazole

Solution for I.V. infusion 200 mg in 100 mL

Injection

Baxter Healthcare Pty Ltd

$25.19

4

Fluconazole

Capsule 100 mg

Oral

Fluconazole Winthrop

$64.99

5

Risperidone

Tablet 0.5 mg

Oral

Risperidone-GA

$16.31

6

Vancomycin

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

Vancomycin Sandoz

$4.09

\n```\n\nSchedule 2\n\n```html\n

Column 1

Column 2

Column 3

Item

Brand of Pharmaceutical Item

Weighted average disclosed price

Listed Drug

Form

Manner of administration

Brand

1

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Adronat

$25.04

2

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

APO-Alendronate

$25.04

3

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Chem mart Alendronate 70mg

$25.04

4

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Terry White Chemists Alendronate 70mg

$25.04

5

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendronate-GA

$25.04

6

Alendronic Acid

Tablet 40 mg (as alendronate sodium)

Oral

Fosamax 40 mg

$82.68

7

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Fosamax Once Weekly

$25.04

8

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Ossmax 70mg

$25.04

9

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendronate Sandoz

$25.04

10

Alendronic Acid

Tablet 70 mg (as alendronate sodium)

Oral

Alendro Once Weekly

$25.04

11

Cisplatin

I.V. injection 50 mg in 50 mL

Injection

Hospira Pty Limited

$10.71

12

Cisplatin

I.V. injection 100 mg in 100 mL

Injection

Hospira Pty Limited

$26.98

13

Cisplatin

I.V. injection 100 mg in 100 mL

Injection

Cisplatin Ebewe

$26.98

14

Cisplatin

I.V. injection 10 mg in 10 mL

Injection

Pfizer Australia Pty Ltd

$3.99

15

Cisplatin

I.V. injection 50 mg in 50 mL

Injection

Pfizer Australia Pty Ltd

$10.71

16

Fluconazole

Solution for I.V. infusion 400 mg in 200 mL

Injection

Baxter Healthcare Pty Ltd

$39.63

17

Fluconazole

Solution for I.V. infusion 100 mg in 50 mL

Injection

Diflucan

$13.39

18

Fluconazole

Solution for I.V. infusion 200 mg in 100 mL

Injection

Diflucan

$25.19

19

Fluconazole

Solution for I.V. infusion 100 mg in 50 mL

Injection

Fluconazole Hexal

$13.39

20

Fluconazole

Solution for I.V. infusion 200 mg in 100 mL

Injection

Fluconazole Hexal

$25.19

21

Fluconazole

Solution for I.V. infusion 200 mg in 100 mL

Injection

Fluconazole Sandoz

$25.19

22

Fluconazole

Capsule 50 mg

Oral

Dizole 50

$33.36

23

Fluconazole

Capsule 100 mg

Oral

Dizole 100

$64.99

24

Fluconazole

Capsule 200 mg

Oral

Dizole 200

$126.60

25

Fluconazole

Capsule 200 mg

Oral

APO-Fluconazole

$126.60

26

Fluconazole

Capsule 50 mg

Oral

DBL Fluconazole

$33.36

27

Fluconazole

Capsule 100 mg

Oral

DBL Fluconazole

$64.99

28

Fluconazole

Capsule 200 mg

Oral

DBL Fluconazole

$126.60

29

Fluconazole

Capsule 50 mg

Oral

Diflucan

$33.36

30

Fluconazole

Capsule 100 mg

Oral

Diflucan

$64.99

31

Fluconazole

Capsule 200 mg

Oral

Diflucan

$126.60

32

Fluconazole

Capsule 50 mg

Oral

Ozole

$33.36

33

Fluconazole

Capsule 100 mg

Oral

Ozole

$64.99

34

Fluconazole

Capsule 200 mg

Oral

Ozole

$126.60

35

Fluconazole

Capsule 50 mg

Oral

Fluconazole Sandoz

$33.36

36

Fluconazole

Capsule 100 mg

Oral

Fluconazole Sandoz

$64.99

37

Fluconazole

Capsule 200 mg

Oral

Fluconazole Sandoz

$126.60

38

Fluconazole

Capsule 200 mg

Oral

Fluconazole Winthrop

$126.60

39

Fluconazole

Capsule 50 mg

Oral

Fluzole 50

$33.36

40

Fluconazole

Capsule 200 mg

Oral

Fluzole 200

$126.60

41

Risperidone

Tablet 0.5 mg

Oral

Rixadone

$16.31

42

Risperidone

Tablet 1 mg

Oral

Rixadone

$31.48

43

Risperidone

Tablet 2 mg

Oral

Rixadone

$72.00

44

Risperidone

Tablet 3 mg

Oral

Rixadone

$111.03

45

Risperidone

Tablet 4 mg

Oral

Rixadone

$149.88

46

Risperidone

Tablet 0.5 mg

Oral

Risperidone-DRLA

$16.31

47

Risperidone

Tablet 1 mg

Oral

Risperidone-DRLA

$31.48

48

Risperidone

Tablet 2 mg

Oral

Risperidone-DRLA

$72.00

49

Risperidone

Tablet 3 mg

Oral

Risperidone-DRLA

$111.03

50

Risperidone

Tablet 4 mg

Oral

Risperidone-DRLA

$149.88

51

Risperidone

Tablet 0.5 mg

Oral

APO-Risperidone

$5.44*

52

Risperidone

Tablet 1 mg

Oral

APO-Risperidone

$31.48

53

Risperidone

Tablet 2 mg

Oral

APO-Risperidone

$72.00

54

Risperidone

Tablet 3 mg

Oral

APO-Risperidone

$111.03

55

Risperidone

Tablet 4 mg

Oral

APO-Risperidone

$149.88

56

Risperidone

Tablet 1 mg

Oral

Risperidone-GA

$31.48

57

Risperidone

Tablet 2 mg

Oral

Risperidone-GA

$72.00

58

Risperidone

Tablet 3 mg

Oral

Risperidone-GA

$111.03

59

Risperidone

Tablet 4 mg

Oral

Risperidone-GA

$149.88

60

Risperidone

Tablet 1 mg

Oral

Risperidone generichealth

$31.48

61

Risperidone

Tablet 2 mg

Oral

Risperidone generichealth

$72.00

62

Risperidone

Tablet 3 mg

Oral

Risperidone generichealth

$111.03

63

Risperidone

Tablet 4 mg

Oral

Risperidone generichealth

$149.88

64

Risperidone

Tablet 0.5 mg

Oral

Risperdal

$5.44*

65

Risperidone

Tablet 1 mg

Oral

Risperdal

$31.48

66

Risperidone

Tablet 2 mg

Oral

Risperdal

$72.00

67

Risperidone

Tablet 3 mg

Oral

Risperdal

$111.03

68

Risperidone

Tablet 4 mg

Oral

Risperdal

$149.88

69

Risperidone

Tablet 0.5mg (orally disintegrating)

Oral

Risperdal Quicklet

$9.13

70

Risperidone

Tablet 1 mg (orally disintegrating)

Oral

Risperdal Quicklet

$18.27

71

Risperidone

Tablet 2 mg (orally disintegrating)

Oral

Risperdal Quicklet

$36.70

72

Risperidone

Tablet 3 mg (orally disintegrating)

Oral

Risperdal Quicklet

$54.54

73

Risperidone

Tablet 4 mg (orally disintegrating)

Oral

Risperdal Quicklet

$72.68

74

Risperidone

Tablet 0.5 mg

Oral

Resdone 0.5

$16.31

75

Risperidone

Tablet 1 mg

Oral

Resdone 1

$31.48

76

Risperidone

Tablet 2 mg

Oral

Resdone 2

$72.00

77

Risperidone

Tablet 3 mg

Oral

Resdone 3

$111.03

78

Risperidone

Tablet 4 mg

Oral

Resdone 4

$149.88

79

Risperidone

Tablet 0.5 mg

Oral

Ozidal

$16.31

80

Risperidone

Tablet 1 mg

Oral

Ozidal

$31.48

81

Risperidone

Tablet 2 mg

Oral

Ozidal

$72.00

82

Risperidone

Tablet 3 mg

Oral

Ozidal

$111.03

83

Risperidone

Tablet 4 mg

Oral

Ozidal

$149.88

84

Risperidone

Tablet 0.5 mg

Oral

Rispa

$16.31

85

Risperidone

Tablet 1 mg

Oral

Rispa

$31.48

86

Risperidone

Tablet 2 mg

Oral

Rispa

$72.00

87

Risperidone

Tablet 3 mg

Oral

Rispa

$111.03

88

Risperidone

Tablet 4 mg

Oral

Rispa

$149.88

89

Vancomycin

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

Vancocin CP

$4.09

90

Vancomycin

Powder for injection 500 mg (500,000 I.U.) (as hydrochloride)

Injection

Hospira Pty Limited

$4.09

91

Vancomycin

Powder for injection 1 g (1,000,000 I.U.) (as hydrochloride)

Injection

Hospira Pty Limited

$8.17

92

Vancomycin

Powder for injection 1g (1,000,000 I.U.) (as hydrochloride)

Injection

Vancomycin Sandoz

$8.17

\n```\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nNote\n\n1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See [http://www.frli.gov.au](http://www.frli.gov.au)\n\n\\* Pack size 20","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"This instrument revokes the earlier determination PB 74 of 2009 and replaces the specified weighted average disclosed prices for the listed brands and forms for the 2009 data collection period. The scope is therefore changed relative to the revoked instrument by substituting a new price schedule for that same retrospective period; no extension beyond the specified period or additional regulatory powers are introduced."},"complexity_factors":["Legal form: a statutory determination under s.99ADB(4) and (5) of the National Health Act 1953, requiring cross-reference to the Act and the National Health (Pharmaceutical Benefits) Regulations 1960.","Operational content: long price tables (two Schedules) listing many brands, strengths and formulations — increases scale of administrative implementation and verification.","Revocation: expressly revokes PB 74 of 2009 and replaces its price specification, which may require reconciliation of historical accounting and reporting.","Temporal scope: fixed data collection period (1 Jan 2009–31 Dec 2009) limits applicability but requires retrospective application to that period.","Delegation and commencement: made by an Assistant Secretary as Ministerial delegate and commences on registration in the Federal Register of Legislative Instruments — administrative steps affect timing.","Simple economic metric: uses a technical pricing concept (weighted average disclosed price) whose calculation details sit in the Regulations, so users must consult secondary rules to apply the figures.","Annotations and pack-size note: presence of an asterisked pack-size remark and formatting quirks may create minor interpretive points for implementation."],"plain_english_summary":"This instrument cancels an earlier determination and sets the weighted average disclosed price (WADP) for specific brands and formulations of Pharmaceutical Benefits Scheme (PBS) medicines for the 2009 data collection year (1 Jan–31 Dec 2009). It applies to the listed brands and dosages in Schedules 1 and 2 and affects pharmaceutical sponsors, suppliers and PBS administrators because those WADPs are used to calculate payments, reporting and pricing outcomes under the National Health Act."},"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":1699},"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This is a routine administrative determination that operates strictly within the scope of section 99ADB of the National Health Act 1953. It updates the weighted average disclosed prices for the 2009 data collection period without expanding beyond the statutory authority to set these benchmark prices for listed pharmaceutical brands."},"complexity_factors":["Made under specific subsections of the National Health Act 1953 (ss 99ADB(4) and (5)) requiring regulatory context","Incorporates by reference the National Health (Pharmaceutical Benefits) Regulations 1960","Contains 98 line items of pharmaceutical data across two schedules with specific drug nomenclature","Uses technical term 'weighted average disclosed price' (WADP) which is a defined concept in pharmaceutical pricing law","Revocation and replacement mechanism of previous instrument PB 74 of 2009"],"plain_english_summary":"This instrument sets weighted average disclosed prices (WADPs) for multiple branded prescription medicines based on 2009 sales data, establishing the government’s subsidy benchmark used to calculate PBS payments and allowable mark‑ups. It affects pharmaceutical companies (benchmarking of their products), pharmacists and patients (out‑of‑pocket costs for subsidised scripts), and revokes an earlier 2009 determination to reflect updated pricing data."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-43-of-","history":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-43-of-/history","analysis":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-43-of-/analysis","conflicts":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-43-of-/conflicts","importantCases":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-43-of-/important-cases","documents":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-43-of-/documents"}}