National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 4)

Link to law: https://www.comlaw.gov.au/Details/F2012L01552

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 4)1
Select Legislative Instrument 2012 No. 168
I, QUENTIN BRYCE, Governor-General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulation under the National Health Act 1953 and the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012.
Dated 12 July 2012
QUENTIN BRYCE
Governor-General
By Her Excellency’s Command
TANYA PLIBERSEK
Minister for Health
1              Name of regulation
                This regulation is the National Health (Pharmaceutical Benefits) Amendment Regulation 2012 (No. 4).
2              Commencement
                This regulation commences on 1 October 2012.
3              Amendment of National Health (Pharmaceutical Benefits) Regulations 1960
                Schedule 1 amends the National Health (Pharmaceutical Benefits) Regulations 1960.
Schedule 1        Amendments
(section 3)
 
[1]           Subregulation 5 (1), definition of authority prescription
omit
subsection 85B (5)
insert
subsection 85B (4)
[2]           Regulation 15
substitute
15            Prescriber bag supplies—practitioners on ships
                A practitioner who is practising his or her profession on a ship is not authorised to supply pharmaceutical benefits under section 93, 93AA or 93AB of the Act.
[3]           Regulation 16, heading
substitute
16            Prescriber bag supplies—obtaining benefits by practitioners
[4]           Subregulation 16 (1)
omit
and 93AA
insert
, 93AA and 93AB
[5]           Regulation 17, heading
substitute
17            Prescriber bag supplies—supply of pharmaceutical benefits by approved pharmacists
[6]           Regulation 18, heading
substitute
18            Prescriber bag supplies—payment for pharmaceutical benefits
[7]           Regulation 18
omit
or 93AA
insert
, 93AA or 93AB
[8]           Subregulation 19 (6)
omit
subsection 85B (5)
insert
subsection 85B (4)
[9]           Paragraph 36 (2) (c)
omit
or 93AA (2)
insert
, 93AA (2) or 93AB (2)
[10]         Subregulation 36 (3), note
omit
subsection 85B (2)
insert
subsection 85B (5)
[11]         Regulation 37A, definition of approved price to pharmacists
omit
[12]         Regulation 37A
insert
start day, in relation to a brand of a pharmaceutical item, means the day on which the price disclosure requirements first apply under section 99ADD of the Act for the brand.
[13]         Regulation 37C
omit
[14]         Regulation 37D
omit
[15]         Regulation 37DA
omit
[16]         Subregulation 37ED (1)
substitute
         (1)   This regulation applies to a listed brand of a pharmaceutical item (the relevant brand) if no requirement to comply with the price disclosure requirements has arisen under the Act before the start day for the relevant brand for:
                (a)    the relevant brand; or
               (b)    any other listed brand of any pharmaceutical item having the same drug and manner of administration as the relevant brand.
[17]         Subregulation 37ED (6), note
omit
[18]         Before subregulation 37EE (1)
insert
      (1A)   This regulation applies to a relevant brand mentioned in subregulation 37ED (1).
[19]         Subregulation 37EE (5)
omit
[20]         Regulation 37F
substitute
37F         Listed brand having same drug and manner of administration as listed brand already subject to price disclosure requirements—first disclosure cycle and beginning of data collection period for brand
         (1)   This regulation applies to a listed brand of a pharmaceutical item (the relevant brand) if the price disclosure requirements apply to any other listed brand of any pharmaceutical item (the other brand) having the same drug and manner of administration as the relevant brand both:
                (a)    before the start day for the relevant brand; and
               (b)    on the start day for the relevant brand.
         (2)   If the end of a data collection period for a disclosure cycle (the relevant disclosure cycle) for the other brand is after the start day for the relevant brand, then:
                (a)    the relevant brand is in the relevant disclosure cycle; and
               (b)    the relevant brand joins the data collection period for the other brand on the start day for the relevant brand.
         (3)   If:
                (a)    the other brand is in both:
                          (i)    the relevant disclosure cycle; and
                         (ii)    a disclosure cycle (the prior disclosure cycle) before the relevant disclosure cycle; and
               (b)    the start day for the relevant brand is before the reduction day for the other brand in the prior disclosure cycle;
then the relevant brand is also in the prior disclosure cycle.
         (4)   If:
                (a)    subregulation (3) applies to a relevant brand; and
               (b)    no other brand of that pharmaceutical item was subject to the price disclosure requirements on both:
                          (i)    the day before the start day for the relevant brand; and
                         (ii)    the start day for the relevant brand;
then the relevant brand is in the data collection period for the other brand, for the purposes of calculating the weighted average disclosed price for the relevant brand.
Note   Although data is not required to be provided for the relevant brand for the prior disclosure cycle, a weighted average disclosed price is determined for the relevant brand using the method in regulation 37G. Regulation 37FA provides a method for working out the approved ex‑manufacturer price on the last day of the data collection period in the prior disclosure cycle.
37FA      Approved ex‑manufacturer price on relevant day
         (1)   This regulation prescribes the method for working out the approved ex‑manufacturer price of a brand of a pharmaceutical item (a relevant brand) on the relevant day for the prior disclosure cycle if:
                (a)    regulation 37F applies to the relevant brand; and
               (b)    the circumstances mentioned in subregulation 37F (4) apply to the relevant brand.
Note 1   Regulation 37F applies to listed brands of pharmaceutical items that have the same drug and manner of administration as listed brands that are already subject to price disclosure requirements.
Note 2   For the definition of relevant day, see subsection 99ADB (1) of the Act.
         (2)   This regulation does not apply to a relevant brand if:
                (a)    the relevant day is 1 October 2012; and
               (b)    the start day for the relevant brand is also 1 October 2012.
         (3)   The method for working out the approved ex‑manufacturer price of a relevant brand on the relevant day for the prior disclosure cycle is to add the following amounts together:
                (a)    the approved ex‑manufacturer price of the relevant brand on the start day for the relevant brand; and
               (b)    any amount that would have been deducted from the approved ex-manufacturer price, under the price reduction provisions, if the relevant brand had been a listed brand in the period that:
                          (i)    begins on the relevant day for the prior disclosure cycle; and
                         (ii)    ends on the start day for the relevant brand.
         (4)   In this regulation:
price reduction provisions means Division 3A of Part VII of the Act.
prior disclosure cycle has the meaning given by subregulation 37F (3).
         (5)   This regulation is made for paragraph 99ADB (3B) (c) of the Act.
[21]         Paragraphs 37G (3) (a) and (6) (a)
omit
relevant day mentioned in paragraph 37ED (1) (a)
insert
start day for the brand
[22]         Subregulation 37G (14)
omit
every brand of every
insert
each brand of each
[23]         Subregulation 37G (14)
omit
brands
insert
brand
[24]         Subregulation 37G (15)
substitute
       (15)   In this regulation:
adjusted volume, of a listed brand of a pharmaceutical item that is sold, means the volume worked out as if the pack sizes in which the brand was sold were equivalent to the pricing quantity of the brand on the relevant day.
Note   For the definition of pricing quantity, see subsection 84AK (1) of the Act.
[25]         Paragraphs 37H (1) (i) and (j)
omit
given for
insert
given in relation to
[26]         Paragraph 37J (3) (a)
omit
relevant day mentioned in regulation 37ED
insert
start day
[27]         Paragraph 37J (3) (b)
omit
relevant
insert
start
[28]         Paragraph 37J (4) (a)
omit
relevant day mentioned in regulation 37F
insert
start day for the relevant brand
[29]         Subparagraph 37J (4) (b) (ii)
omit
relevant
insert
start
[30]         After Part 7
insert
Part 8                 Transitional provisions
Division 1              Provisions for National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012
49            Approved ex-manufacturer prices on 1 October 2012
         (1)   Schedule 7 sets out the approved ex-manufacturer price on 1 October 2012 for each brand of a pharmaceutical item listed in Schedule 7.
         (2)   This regulation is made for paragraph 70 (a) of Schedule 1 to the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012.
50            Determination of weighted average disclosed price
         (1)   This regulation applies if:
                (a)    the weighted average disclosed price of a listed brand of a pharmaceutical item is determined on or before 30 September 2012; and
               (b)    after 30 September 2012, another weighted average disclosed price (a new price) is to be determined for the listed brand for the same disclosure cycle.
         (2)   The new price must be determined according to the provisions of these regulations as in force immediately before 1 October 2012.
[31]         After Schedule 6
insert
Schedule 7        Approved ex-manufacturer prices on 1 October 2012
(regulation 49)
  
Item
Brand of pharmaceutical item
Approved ex-manufacturer price ($)

Drug
Form
Manner of administration
Brand

1
Doxorubicin-Pegylated Liposomal
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
Injection
Caelyx
622.99

2
Doxorubicin-Pegylated Liposomal
Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL
Injection
Lipodox
622.99

3
Etanercept
Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL
Injection
Enbrel
815.00

4
Follitropin Alfa
Injection 300 I.U. in 0.5 mL multi-dose cartridge
Injection
Gonal-f Pen
144.00

5
Follitropin Alfa
Injection 450 I.U. in 0.75 mL multi-dose cartridge
Injection
Gonal-f Pen
216.00

6
Follitropin Alfa
Injection 900 I.U. in 1.5 mL multi-dose cartridge
Injection
Gonal-f Pen
432.00

7
Follitropin Beta
Solution for injection 300 I.U. in 0.36 mL multi-dose cartridge
Injection
Puregon
300 IU/0.36 mL
144.04

8
Follitropin Beta
Solution for injection 450 I.U. in 0.72 mL multi-dose cartridge
Injection
Puregon
600 IU/0.72 mL
288.09

9
Follitropin Beta
Solution for injection 900 I.U. in 1.08 mL multi-dose cartridge
Injection
Puregon
900 IU/1.08 mL
432.11

10
Rituximab
Solution for I.V. infusion 500 mg in 50 mL
Injection
Mabthera
2 263.57

11
Temozolomide
Capsule 100 mg
Oral
Astromide
602.32

12
Temozolomide
Capsule 100 mg
Oral
Temizole 100
602.32

13
Temozolomide
Capsule 100 mg
Oral
Temodal
602.32

14
Temozolomide
Capsule 140 mg
Oral
Astromide
830.65

15
Temozolomide
Capsule 140 mg
Oral
Temizole 140
830.65

16
Temozolomide
Capsule 140 mg
Oral
Temodal
830.65

[32]         Further amendments—start day
                The following provisions are amended by omitting each mention of ‘relevant day’ and inserting ‘start day’:
       ·    regulation 37ED
       ·    regulation 37EE.
Note
1.       All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See www.comlaw.gov.au.