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SLI 2008 No. 116 Regulations as made
These Regulations amend the National Health (Pharmaceutical Benefits) Regulations 1960 to provide for new pricing arrangements to enable the Government to capture the benefits of competition where drugs have multiple brands.
Administered by: Health
Registered 20 Jun 2008
Tabling HistoryDate
Tabled HR23-Jun-2008
Tabled Senate24-Jun-2008
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

National Health (Pharmaceutical Benefits) Amendment Regulations 2008 (No. 2)1

Select Legislative Instrument 2008 No. 116

I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the National Health Act 1953.

Dated 19 June 2008

P. M. JEFFERY

Governor‑General

By His Excellency’s Command

NICOLA ROXON


1              Name of Regulations

                These Regulations are the National Health (Pharmaceutical Benefits) Amendment Regulations 2008 (No. 2).

2              Commencement

                These Regulations commence on the day after they are registered.

3              Amendment of National Health (Pharmaceutical Benefits) Regulations 1960

                Schedule 1 amends the National Health (Pharmaceutical Benefits) Regulations 1960.


Schedule 1             Amendments

(regulation 3)

  

[1]           Paragraph 37D (a)

omit

$970

insert

$1 000

[2]           Subregulations 37F (8) to (16), including the note

substitute

Step 4

         (8)   Work out the disclosed price for the brand by dividing the net revenue for the brand by its adjusted volume.

Step 5

         (9)   Work out the price percentage difference for the brand by:

                (a)    subtracting its disclosed price from its approved ex‑manufacturer price; and

               (b)    dividing that amount by its approved ex‑manufacturer price.

Step 6

       (10)   Work out the adjusted price percentage difference for the brand (expressed as a percentage to 2 decimal places) as follows:

                (a)    if the price percentage difference for the brand is less than zero, the adjusted price percentage difference is equal to zero; and

               (b)    if the price percentage difference for the brand is equal to or greater than zero, the adjusted price percentage difference is equal to the price percentage difference.

Step 7

       (11)   Repeat steps 1 to 6 for every brand of the pharmaceutical item.

Step 8

       (12)   Work out the weighted average percentage difference for the pharmaceutical item as follows:

                (a)    for each brand of the pharmaceutical item — multiply its adjusted volume by its adjusted price percentage difference; and

               (b)    add up the amounts worked out in paragraph (a); and

                (c)    add up the adjusted volume for each brand of the pharmaceutical item; and

               (d)    divide the amount worked out in paragraph (b) by the amount worked out in paragraph (c).

Step 9

       (13)   Repeat steps 1 to 8 for every pharmaceutical item having the same drug and manner of administration.

Step 10

       (14)   Work out the weighted average percentage difference (expressed as a percentage to 2 decimal places) for every brand of every pharmaceutical item having the same drug and manner of administration in the following way:

                (a)    for each pharmaceutical item — multiply the percentage worked out in step 8 by:

                          (i)    the PBS volume of the pharmaceutical item, as recorded by the Department; and

                         (ii)    the approved ex‑manufacturer price for the brands of the pharmaceutical item;

               (b)    for each pharmaceutical item — multiply the PBS volume of the pharmaceutical item by the approved ex‑manufacturer price for the brands of the pharmaceutical item;

                (c)    add up the amounts worked out for each pharmaceutical item under paragraph (a);

               (d)    divide the amount worked out under paragraph (c) by the sum of the amounts worked out under paragraph (b).

Step 11

       (15)   If the percentage worked out under step 10 is 10% or more, the weighted average disclosed price for every brand of every pharmaceutical item having the same drug and manner of administration is the approved ex‑manufacturer price for the brands reduced by that percentage.

Note   If the percentage is less than 10%, there will be no price reduction.

[3]           After regulation 37H

insert

37HA      Price disclosure requirements — prescribed person

                For paragraph 99ADC (1) (a) of the Act, the information must be provided to:

                        Assistant Secretary

                        Pharmaceutical Evaluation Branch

                        Pharmaceutical Benefits Division

                        Department of Health and Ageing.


[4]           Schedule 5

substitute

Schedule 5        Listed brands of pharmaceutical items, reduction days and percentages

(regulation 37B)

  

Item

Listed brand of pharmaceutical item

Reduction days

Percentage

Brand

Drug

Form

Manner of administration

1

Nexium

Esomeprazole

Tablet (enteric coated) 20 mg (as magnesium trihydrate)

Oral

1)  1 August 2008

2)  1 August 2011

3)  1 August 2014

4)  1 August 2018

1)   4%

2)   7%

3)   7%

4)   7%

Nexium

Esomeprazole

Tablet (enteric coated) 40 mg (as magnesium trihydrate)

Oral

2

Zoton

Lansoprazole

Capsule 15 mg

Oral

1)  1 August 2008

2)  1 August 2009

3)  1 August 2010

1)   5%

2)   5%

3)   15%

Zoton

Lansoprazole

Capsule 30 mg

Oral

3

Somac

Pantoprazole

Tablet (enteric coated) 20 mg (as sodium sesquihydrate)

Oral

1)  1 August 2008

2)  1 August 2011

3)  1 August 2014

4)  1 August 2018

1)   4%

2)   7%

3)   7%

4)   7%

Somac

Pantoprazole

Tablet (enteric coated) 40 mg (as sodium sesquihydrate)

Oral

4

Pariet

Rabeprazole

Tablet (enteric coated) containing 10mg rabeprazole sodium

Oral

1)  1 August 2008

2)  1 August 2011

3)  1 August 2014

4)  1 August 2018

1)   4%

2)   7%

3)   7%

4)   7%

Pariet

Rabeprazole

Tablet (enteric coated) containing 20mg rabeprazole sodium

Oral

5

Zanidip

Lercanidipine

Tablet 10 mg

Oral

1)  1 August 2008

2)  1 August 2011

3)  1 August 2014

4)  1 August 2018

1)   4%

2)   7%

3)   7%

4)   7%

Zanidip

Lercanidipine

Tablet 20 mg

Oral


Note

1.       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.