Commonwealth Consolidated Acts

NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS--BUDGET AND OTHER MEASURES) ACT 2018 - SCHEDULE 3

Part   1 -- Amendments commencing day after Royal Assent

National Health Act 1953

1   Subsection   99ADB(1)

Insert:

"data collection period" , for a brand of a pharmaceutical item, has the meaning given by section   99ADBA.

"related brand" , of a brand of a pharmaceutical item, means a brand of a pharmaceutical item that has the same drug and manner of administration as the first - mentioned pharmaceutical item (including another brand of the same pharmaceutical item), but does not include a brand of an exempt item.

"start day" , for a brand of a pharmaceutical item, means the day that the brand was first required to comply with the price disclosure requirements under section   99ADD.

2   At the end of Subdivision A of Division   3B of Part   VII

Add:

99ADBA   Meaning of data collection period

Start of first data collection period

  (1)   The first data collection period for a brand of a pharmaceutical item starts on the brand's start day.

End of first data collection period

  (2)   If, on the day before the brand's start day (the starting brand ) the price disclosure requirements apply to a related brand of the starting brand, the starting brand's first data collection period ends when the data collection period for any of the related brands ends.

  (3)   Otherwise, the starting brand's first data collection period ends on:

  (a)   if the start day occurs between 2   April and 1   October--the next 31   March; or

  (b)   if the start day occurs between 2   October and 1   April--the next 30   September.

Start and end of subsequent data collection periods

  (4)   After the first data collection period for a listed brand of a pharmaceutical item, each subsequent data collection period for the brand:

  (a)   starts immediately after the end of the previous data collection period; and

  (b)   ends on the next 31   March or 30   September, whichever is sooner.

Example 1:   If a brand to which subsection   ( 2) applies has a start day of 1   July 201 6 , and the data collection period for a related brand ends on 30   September 201 6 :

(a)   the first data collection period starts on 1   July 201 6 ; and

(b)   the first data collection period ends on 30   September 201 6 ; and

(c)   subsequent data collection periods will be the 6 month periods that start on 1   October 201 6 , 1   April 201 7 , 1   October 201 7 and so on.

Example 2:   If a brand to which subsection   ( 3) applies has a start day of 1   August 201 6 :

(a)   the first data collection period starts on 1   August 201 6 ; and

(b)   the first data collection period ends on 31   March 201 7 ; and

(c)   subsequent data collection periods will be the 6 month periods that start on 1   April 201 7 , 1   October 201 7 , 1   April 201 8 and so on.

Example 3:   If a brand to which subsection   ( 3) applies has a start day of 1   December 201 6 :

(a)   the first data collection period starts on 1   December 201 6 ; and

(b)   the first data collection period ends on 30   September 201 7 ; and

(c)   subsequent data collection periods will be the 6 month periods that start on 1   October 2017, 1   April 2018 , 1   October 201 8 and so on.

3   Paragraph   9 9ADH(1)(a)

After "pharmaceutical item", insert " (the WADP brand ) in respect of a data collection period for the brand".

4   Paragraph   9 9ADH(1)(c)

Repeal the paragraph, substitute:

  (c)   the unadjusted price reduction for the brand of the pharmaceutical item is:

  (i)   if the drug and manner of administration of the pharmaceutical item has been on F2 for less than 42 months-- at least 10%; and

  (ii)   subject to subparagraph   ( iii), if the drug and manner of administration of the pharmaceutical item has been on F2 for at least 42 months-- at least 30%; and

  (iii)   if the drug and manner of administration of the pharmaceutical item has been on F2 for at least 42 months and has had 2 consecutive price reductions under subparagraph   ( ii) in relation to the brand of the pharmaceutical item-- at least 10%.

5   After subsection   99A DH(2)

Insert:

  (2 A )   For the purposes of paragraph   ( 1)(c), t he drug and manner of administration of a pharmaceutical item is taken to have been on F2 for at least 42 months if:

  (a)   at end of the previous data collection period, the drug in the WADP brand had been on F2 for at least 42 months; and

  (b)   on a day at least 42 months before the end of the previous data collection period:

  (i)   there was a related brand of the WADP brand that had the same pharmaceuti cal item as, or was bio equivalent or biosimilar to, the WADP brand; or

  (ii)   there were 2 or more related brands of the WADP brand that had the same pha rmaceutical item as, or were bio equivale nt or biosimilar to, each other .

6   Subsection   99 ADH (5)

Omit "after the reduction day", substitute "on or after the reduction day".

7   Application

The amendments made by this Part apply to a determination of a day (the reduction day ) by the Minister, by legislative instrument, for the purposes of section   99ADH of the National Health Act 1953 if the reduction day occurs on or after the day this item commences.