{"id":"F2010L02535","name":"National Health Act 1953 - Determination made pursuant to subsections 99ADB(4) and 99ADB(5) (No. PB 85 of 2010)","slug":"national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-85-of-","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":84472,"registerId":"commonwealth-F2010L02535-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Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health Act 1953 - Determination made pursuant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 85 of 2010)","content":"![](image.001.png)\n\nCOMMONWEALTH OF AUSTRALIA\n\nInstrument number PB 85 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 May 2009 to 30 April 2010 (inclusive)\n\nI, FELICITY MC NEILL, delegate of the Minister for Health and Ageing:\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 is expressed to commence on the later of the following:\n\n(a) immediately after the commencement of PB 43 of 2010;\n\n(b) the day after it is registered 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

Carvedilol

Tablet 3.125 mg

Oral

Dilasig 3.125

6.49

2

Gemcitabine

Solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL

Injection

Gemcitabine Ebewe

26.57

3

Irinotecan

I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL

Injection

Irinotecan Sandoz

42.92

4

Paclitaxel

Solution concentrate for I.V. infusion 30 mg in 5 mL

Injection

Taxol

78.49

\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

Carvedilol

Tablet 3.125 mg

Oral

Chem mart Carvedilol 3.125 mg

6.49

2

Carvedilol

Tablet 3.125 mg

Oral

GenRx Carvedilol

6.49

3

Carvedilol

Tablet 3.125 mg

Oral

Terry White Chemists Carvedilol 3.125 mg

6.49

4

Carvedilol

Tablet 3.125 mg

Oral

GN-Carvedilol

6.49

5

Carvedilol

Tablet 3.125 mg

Oral

Dilatrend 3.125

6.49

6

Carvedilol

Tablet 3.125 mg

Oral

Kredex

6.49

7

Carvedilol

Tablet 3.125 mg

Oral

Vedilol 3.125

6.49

8

Carvedilol

Tablet 6.25 mg

Oral

Dicarz

30.71

9

Carvedilol

Tablet 6.25 mg

Oral

APO-Carvedilol

30.71

10

Carvedilol

Tablet 6.25 mg

Oral

Chem mart Carvedilol 6.25 mg

30.71

11

Carvedilol

Tablet 6.25 mg

Oral

GenRx Carvedilol

30.71

12

Carvedilol

Tablet 6.25 mg

Oral

Terry White Chemists Carvedilol 6.25 mg

30.71

13

Carvedilol

Tablet 6.25 mg

Oral

GN-Carvedilol

30.71

14

Carvedilol

Tablet 6.25 mg

Oral

Dilasig 6.25

30.71

15

Carvedilol

Tablet 6.25 mg

Oral

Carvedilol generichealth

30.71

16

Carvedilol

Tablet 6.25 mg

Oral

Dilatrend 6.25

30.71

17

Carvedilol

Tablet 6.25 mg

Oral

Kredex

30.71

18

Carvedilol

Tablet 6.25 mg

Oral

Carvedilol Sandoz

30.71

19

Carvedilol

Tablet 6.25 mg

Oral

Vedilol 6.25

30.71

20

Carvedilol

Tablet 12.5 mg

Oral

Dicarz

38.39

21

Carvedilol

Tablet 12.5 mg

Oral

APO-Carvedilol

38.39

22

Carvedilol

Tablet 12.5 mg

Oral

Chem mart Carvedilol 12.5 mg

38.39

23

Carvedilol

Tablet 12.5 mg

Oral

GenRx Carvedilol

38.39

24

Carvedilol

Tablet 12.5 mg

Oral

Terry White Chemists Carvedilol 12.5 mg

38.39

25

Carvedilol

Tablet 12.5 mg

Oral

GN-Carvedilol

38.39

26

Carvedilol

Tablet 12.5 mg

Oral

Dilasig 12.5

38.39

27

Carvedilol

Tablet 12.5 mg

Oral

Carvedilol generichealth

38.39

28

Carvedilol

Tablet 12.5 mg

Oral

Dilatrend 12.5

38.39

29

Carvedilol

Tablet 12.5 mg

Oral

Kredex

38.39

30

Carvedilol

Tablet 12.5 mg

Oral

Carvedilol Sandoz

38.39

31

Carvedilol

Tablet 12.5 mg

Oral

Vedilol 12.5

38.39

32

Carvedilol

Tablet 25 mg

Oral

Dicarz

47.99

33

Carvedilol

Tablet 25 mg

Oral

APO-Carvedilol

47.99

34

Carvedilol

Tablet 25 mg

Oral

Chem mart Carvedilol 25 mg

47.99

35

Carvedilol

Tablet 25 mg

Oral

GenRx Carvedilol

47.99

36

Carvedilol

Tablet 25 mg

Oral

Terry White Chemists Carvedilol 25 mg

47.99

37

Carvedilol

Tablet 25 mg

Oral

GN-Carvedilol

47.99

38

Carvedilol

Tablet 25 mg

Oral

Dilasig 25

47.99

39

Carvedilol

Tablet 25 mg

Oral

Carvedilol generichealth

47.99

40

Carvedilol

Tablet 25 mg

Oral

Dilatrend 25

47.99

41

Carvedilol

Tablet 25 mg

Oral

Kredex

47.99

42

Carvedilol

Tablet 25 mg

Oral

Carvedilol Sandoz

47.99

43

Carvedilol

Tablet 25 mg

Oral

Vedilol 25

47.99

44

Gemcitabine

Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL

Injection

Gemcitabine Ebewe

65.60

45

Gemcitabine

Solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL

Injection

Gemcitabine Ebewe

131.20

46

Gemcitabine

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

Gemcitabine Ebewe

26.57

47

Gemcitabine

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

Gemcitabine Actavis

26.57

48

Gemcitabine

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

DBL Gemcitabine for Injection

26.57

49

Gemcitabine

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

Gemcite

26.57

50

Gemcitabine

Powder for I.V. infusion 200 mg (as hydrochloride)

Injection

Gemzar

26.57

51

Gemcitabine

Powder for I.V. infusion 1 g (as hydrochloride)

Injection

Gemcitabine Actavis

131.20

52

Gemcitabine

Powder for I.V. infusion 1 g (as hydrochloride)

Injection

DBL Gemcitabine for Injection

131.20

53

Gemcitabine

Powder for I.V. infusion 1 g (as hydrochloride)

Injection

Gemcitabine Ebewe

131.20

54

Gemcitabine

Powder for I.V. infusion 1 g (as hydrochloride)

Injection

Gemcite

131.20

55

Gemcitabine

Powder for I.V. infusion 1 g (as hydrochloride)

Injection

Gemzar

131.20

56

Gemcitabine

Powder for I.V. infusion 2 g (as hydrochloride)

Injection

DBL Gemcitabine for Injection

262.99

57

Irinotecan

I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in

2 mL

Injection

Irinotecan Alphapharm

42.92

\n```\n\n \n\n| 58 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in2 mL | Injection | Irinotecan Actavis | 42.92 |\n| --- | ---------- | --------------------------------------------------------------------------- | --------- | --------------------- | ------ |\n| 59 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in2 mL | Injection | Irinotecan Ebewe | 42.92 |\n| 60 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in2 mL | Injection | Omegapharm Irinotecan | 42.92 |\n| 61 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in2 mL | Injection | Hospira Pty Limited | 42.92 |\n| 62 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in2 mL | Injection | Camptosar | 42.92 |\n| 63 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in2 mL | Injection | Tecan | 42.92 |\n| 64 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Irinotecan Alphapharm | 107.29 |\n| 65 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Irinotecan Actavis | 107.29 |\n| 66 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Irinotecan Ebewe | 107.29 |\n| 67 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Omegapharm Irinotecan | 107.29 |\n\n \n\n| 68 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Irinotecan Sandoz | 107.29 |\n| --- | ---------- | ---------------------------------------------------------------------------- | --------- | ------------------- | ------- |\n| 69 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Hospira Pty Limited | 107.29 |\n| 70 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Camptosar | 107.29 |\n| 71 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in5 mL | Injection | Tecan | 107.29 |\n| 72 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in15 mL | Injection | Irinotecan Ebewe | 321.58 |\n| 73 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in15 mL | Injection | Camptosar | 321.58 |\n| 74 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in25 mL | Injection | Irinotecan Ebewe | 549.75 |\n| 75 | Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in25 mL | Injection | Hospira Pty Limited | 549.75 |\n| 76 | Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | Paclitaxel Actavis | 78.49 |\n| 77 | Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | Anzatax | 78.49 |\n| 78 | Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | Paclitaxel Ebewe | 392.48* |\n\n \n\n| 79 | Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL | Injection | Plaxel | 78.49 |\n| --- | ---------- | -------------------------------------------------------- | --------- | ------------------ | ------ |\n| 80 | Paclitaxel | Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | Taxol | 260.37 |\n| 81 | Paclitaxel | Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | Paclitaxel Actavis | 260.37 |\n| 82 | Paclitaxel | Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | Anzatax | 260.37 |\n| 83 | Paclitaxel | Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | Paclitaxel Ebewe | 260.37 |\n| 84 | Paclitaxel | Solution concentrate for I.V. infusion 100 mg in 16.7 mL | Injection | Plaxel | 260.37 |\n| 85 | Paclitaxel | Solution concentrate for I.V. infusion 150 mg in 25 mL | Injection | Paclitaxel Actavis | 379.52 |\n| 86 | Paclitaxel | Solution concentrate for I.V. infusion 150 mg in 25 mL | Injection | Anzatax | 379.52 |\n| 87 | Paclitaxel | Solution concentrate for I.V. infusion 150 mg in 25 mL | Injection | Paclitaxel Ebewe | 379.52 |\n| 88 | Paclitaxel | Solution concentrate for I.V. infusion 150 mg in 25 mL | Injection | Plaxel | 379.52 |\n| 89 | Paclitaxel | Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | Taxol | 790.88 |\n| 90 | Paclitaxel | Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | Paclitaxel Actavis | 790.88 |\n| 91 | Paclitaxel | Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | Anzatax | 790.88 |\n| 92 | Paclitaxel | Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | Paclitaxel Ebewe | 790.88 |\n| 93 | Paclitaxel | Solution concentrate for I.V. infusion 300 mg in 50 mL | Injection | Plaxel | 790.88 |\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 5","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":1900},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument performs exactly as authorised by the enabling subsections (99ADB(4) and (5)), setting weighted average disclosed prices for the specified data collection period without expanding beyond this statutory purpose."},"complexity_factors":["Tabular data structure containing 93 distinct price determinations across two schedules","Technical terminology requiring understanding of PBS price disclosure policy (weighted average disclosed price)","Cross-reference to enabling subsections 99ADB(4) and 99ADB(5) of the National Health Act 1953","Commencement clause contingent on registration of another legislative instrument (PB 43 of 2010)"],"plain_english_summary":"This instrument sets the official weighted average disclosed prices (WADPs) for 93 listed PBS prescription products, using manufacturers’ reported sales from 1 May 2009–30 April 2010. \n\nThat price list determines how much the government reimburses pharmacists, impacts what pharmaceutical companies receive, and helps set patient co‑payments, ensuring subsidies reflect actual market transaction prices rather than manufacturers’ list prices."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument does not expand or contract the statutory scope of the National Health Act 1953. It implements the Act’s regulatory mechanism by specifying the weighted average disclosed prices for particular brands and pack sizes for a defined data collection period (pursuant to ss 99ADB(4) and (5)), i.e. an administrative pricing determination rather than a change to legislative scope."},"complexity_factors":["Statutory cross-reference to subsections 99ADB(4) and 99ADB(5) of the National Health Act 1953, requiring legal conformity with the Act and the National Health (Pharmaceutical Benefits) Regulations 1960","Extensive tabular schedules listing many brands, dosage forms, strengths and pack sizes, each with a specific numeric WADP","Commencement conditions tied to another instrument (PB 43 of 2010) and registration on the Federal Register of Legislative Instruments","Operational/administrative effect on PBS pricing and reimbursement despite being a non-technical administrative determination","Time‑limited application (explicit data collection period 1 May 2009–30 April 2010) requiring correct temporal application by administrators and claimants","Reliance on a ministerial delegate to set numeric values — limited discretion but direct financial consequences for suppliers and payers"],"plain_english_summary":"This instrument (PB 85 of 2010) records the weighted average disclosed prices (WADPs) for named brands and pack sizes of listed pharmaceuticals for the data collection period 1 May 2009–30 April 2010. It is a delegate’s determination under ss 99ADB(4)–(5) of the National Health Act 1953 that fixes official WADPs used in Pharmaceutical Benefits Scheme pricing and reimbursement calculations. The Minister’s delegate decides the values; suppliers, pharmacists and the government must use them for PBS claims and pricing arrangements."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-85-of-","history":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-85-of-/history","analysis":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-85-of-/analysis","conflicts":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-85-of-/conflicts","importantCases":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-85-of-/important-cases","documents":"/api/acts/national-health-act-1953-determination-made-pursuant-to-subsections-99adb-4-and-99adb-5-no-pb-85-of-/documents"}}