National Health (Weighted average disclosed price - supplementary disclosure cycle A) Determination 2013 (No. PB 24 of 2013)

Administered by Department of Health, Disability and Ageing

Legislation au F2013L00688 Not in force Legislative Instrument

Legislation content

National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013 (PB 24 of 2013)

as amended

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

National Health Act 1953

Compilation start date:  9 July 2013

Includes amendments up to: PB 38 of 2013

About this compilation

This compilation

This is a compilation of the National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013 (PB 24 of 2013) as in force on 9 July 2013. It includes any commenced amendment affecting the compilation to that date.

This compilation was prepared on 16 August 2013.

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision.

Uncommenced amendments

The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes.

 

 

 

 

 

Contents

1 Name of Determination

2 Commencement

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 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%

Endnotes

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]

 

1  Name of Determination

 (1) This Determination is the National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013.

 (2) This Determination may also be cited as PB 24 of 2013.

2  Commencement

  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.

supplementary disclosure cycle A has the same meaning as in regulation 37EB(2)(c) 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  Reduction Day

  For paragraph 99ADH(1)(aa) of the Act, a brand of pharmaceutical item in a supplementary disclosure cycle A with a data collection period ending at the end of 31 January 2013 which is mentioned in Schedule 1 or 2 has a reduction day of 1 August 2013.

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

 

Column 1

Column 2

Column 3

Item

Brand of Pharmaceutical Item

Weighted average disclosed price

 

Drug

Form

Manner of administration

Brand

 

1

Dexamethasone

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL

Injection

Dexmethsone

6.77

2

Dexamethasone

Injection containing dexamethasone sodium phosphate equivalent to 4 mg dexamethasone phosphate in 1 mL

Injection

Hospira Pty Limited

6.77

3

Dexamethasone

Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

Injection

Dexmethsone

12.3

4

Dexamethasone

Injection containing dexamethasone sodium phosphate equivalent to 8 mg dexamethasone phosphate in 2 mL

Injection

Hospira Pty Limited

12.3

5

Temozolomide

Capsule 100 mg

Oral

Orion Temozolomide

455.17

6

Temozolomide

Capsule 100 mg

Oral

Temodal

455.17

7

Temozolomide

Capsule 100 mg

Oral

Temizole 100

455.17

8

Temozolomide

Capsule 100 mg

Oral

Astromide

455.17

9

Temozolomide

Capsule 140 mg

Oral

Astromide

627.72

10

Temozolomide

Capsule 140 mg

Oral

Orion Temozolomide

627.72

11

Temozolomide

Capsule 140 mg

Oral

Temodal

627.72

12

Temozolomide

Capsule 140 mg

Oral

Temizole 140

627.72

12A

Temozolomide

Capsule 180 mg

Oral

Temodal

795.30

13

Temozolomide

Capsule 20 mg

Oral

Astromide

106.25

14

Temozolomide

Capsule 20 mg

Oral

Temizole 20

106.25

15

Temozolomide

Capsule 20 mg

Oral

Orion Temozolomide

106.25

16

Temozolomide

Capsule 20 mg

Oral

Temodal

106.25

17

Temozolomide

Capsule 250 mg

Oral

Astromide

1081.44

18

Temozolomide

Capsule 250 mg

Oral

Temodal

1081.44

19

Temozolomide

Capsule 250 mg

Oral

Temizole 250

1081.44

20

Temozolomide

Capsule 250 mg

Oral

Orion Temozolomide

1081.44

21

Temozolomide

Capsule 5 mg

Oral

Temizole 5

36.14

22

Temozolomide

Capsule 5 mg

Oral

Astromide

36.14

23

Temozolomide

Capsule 5 mg

Oral

Orion Temozolomide

36.14

24

Temozolomide

Capsule 5 mg

Oral

Temodal

36.14

 

 

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

Dexamethasone

Eye drops 1 mg per mL, 5 mL

Application to the eye

Maxidex

3.38

2

Dexamethasone

Tablet 4 mg

Oral

Dexmethsone

4.45

3

Dexamethasone

Tablet 500 micrograms

Oral

Dexmethsone

1.79

Endnotes

Endnote 1—About the endnotes

The endnotes provide details of the history of this legislation and its provisions. The following endnotes are included in each compilation:

 

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Endnote 5—Uncommenced amendments

Endnote 6—Modifications

Endnote 7—Misdescribed amendments

Endnote 8—Miscellaneous

 

If there is no information under a particular endnote, the word “none” will appear in square brackets after the endnote heading.

 

Abbreviation key—Endnote 2

The abbreviation key in this endnote sets out abbreviations that may be used in the endnotes.

 

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

 

The legislation history in endnote 3 provides information about each law that has amended the compiled law. The information includes commencement information for amending laws and details of application, saving or transitional provisions that are not included in this compilation.

 

The amendment history in endnote 4 provides information about amendments at the provision level. It also includes information about any provisions that have expired or otherwise ceased to have effect in accordance with a provision of the compiled law.

 

Uncommenced amendments—Endnote 5

The effect of uncommenced amendments is not reflected in the text of the compiled law, but the text of the amendments is included in endnote 5.

 

Modifications—Endnote 6

If the compiled law is affected by a modification that is in force, details of the modification are included in endnote 6.

 

Misdescribed amendments—Endnote 7

An amendment is a misdescribed amendment if the effect of the amendment cannot be incorporated into the text of the compilation. Any misdescribed amendment is included in endnote 7.

 

Miscellaneous—Endnote 8

Endnote 8 includes any additional information that may be helpful for a reader of the compilation.

 

Endnote 2—Abbreviation key

 

ad = added or inserted

pres = present

am = amended

prev = previous

c = clause(s)

(prev) = previously

Ch = Chapter(s)

Pt = Part(s)

def = definition(s)

r = regulation(s)/rule(s)

Dict = Dictionary

Reg = Regulation/Regulations

disallowed = disallowed by Parliament

reloc = relocated

Div = Division(s)

renum = renumbered

exp = expired or ceased to have effect

rep = repealed

hdg = heading(s)

rs = repealed and substituted

LI = Legislative Instrument

s = section(s)

LIA = Legislative Instruments Act 2003

Sch = Schedule(s)

mod = modified/modification

Sdiv = Subdivision(s)

No. = Number(s)

SLI = Select Legislative Instrument

o = order(s)

SR = Statutory Rules

Ord = Ordinance

Sub-Ch = Sub-Chapter(s)

orig = original

SubPt = Subpart(s)

par = paragraph(s)/subparagraph(s)

 

sub-subparagraph(s)

 

 

 

Endnote 3—Legislation history

 

Title

FRLI registration

Commencement

Application, saving
and transitional provisions

PB 24 of 2013

26 Apr 2013 (see F2013L00688)

27 Apr 2013

 

PB 38 of 2013

8 July 2013 (see F2013L01328)

9 July 2013

—

 

Endnote 4—Amendment history

 

ad. = added or inserted    am. = amended    rep. = repealed    rs. = repealed and substituted    exp. = expired or ceased to have effect

Provision affected

How affected

Sch 1

 

Sch 1...................

am PB 38 of 2013

 

Endnote 5—Uncommenced amendments [none]

Endnote 6—Modifications [none]

Endnote 7—Misdescribed amendments [none]

Endnote 8—Miscellaneous [none]

 

 

Overview

The National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013 was enacted to address the need for supplementary disclosure cycles under the National Health Act 1953. This legislative instrument was introduced by the Parliament of Australia to ensure the appropriate pricing of pharmaceutical items by providing weighted average disclosed prices for brands with significant price reductions. The policy objective is to maintain transparency and fairness in the pharmaceutical pricing framework, ensuring that patients have access to affordable medications while supporting the sustainability of the Pharmaceutical Benefits Scheme (PBS). The determination sets out specific weighted average disclosed prices for brands of pharmaceutical items with varying levels of unadjusted price reductions, ensuring that the pricing reflects market conditions and provides value to consumers.

Scope and Application

The National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013 is a legislative instrument made under the National Health Act 1953. It specifies the weighted average disclosed price for certain brands of pharmaceutical items that are subject to a supplementary disclosure cycle A, as defined in the Act. This determination applies to pharmaceutical brands that underwent an unadjusted price reduction of at least 10% or less than 10%, as listed in Schedules 1 and 2 respectively. The specified prices are relevant for brands that had a data collection period ending on 31 January 2013, with a reduction day of 1 August 2013. The application of this Determination is limited to the Commonwealth of Australia, and it supplements the pricing disclosures required under the Act. It does not contain any specific exclusions, exemptions, or thresholds, but rather works in conjunction with the primary legislation to ensure accurate and timely pricing information is disclosed. The Determination is subject to amendment through subordinate instruments, as evidenced by the amendment made by PB 38 of 2013.

Key Provisions

The National Health (Weighted average disclosed price—supplementary disclosure cycle A) Determination 2013, as in force on 9 July 2013, provides specifications for the weighted average disclosed prices of certain brands of pharmaceutical items as part of supplementary disclosure cycle A under the National Health Act 1953. The determination specifies the weighted average disclosed price for brands of pharmaceutical items where the unadjusted price reduction is at least 10% (section 4) and less than 10% (section 5). For brands where the unadjusted price reduction is at least 10%, the adjusted approved ex-manufacturer price is also specified (section 6). The schedules attached to the determination list the specific brands and their corresponding weighted average disclosed prices. The determination is applicable to brands of pharmaceutical items in supplementary disclosure cycle A, which have a data collection period ending at the end of 31 January 2013 (section 7). The obligations under this determination include ensuring that the weighted average disclosed prices and the adjusted approved ex-manufacturer prices for the specified brands of pharmaceutical items are accurately determined and disclosed as per the schedules. Pharmaceutical companies and other entities involved in the supply of these pharmaceutical items are required to comply with the specified prices as outlined in the schedules. This involves providing accurate and timely data to the relevant authorities, ensuring that the prices are in line with the requirements of the National Health Act and the determination itself. The determination does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of its provisions. However, under the National Health Act 1953, there are provisions for penalties and enforcement actions for non-compliance with the Act's requirements. These can include fines and other penalties as stipulated under the Act, and may also involve legal actions to ensure compliance with the specified requirements. The exact penalties would depend on the specific breach and the provisions of the Act that are applicable.

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