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
Minister for Health and Ageing
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.