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Schedule 3—Price disclosure price reduction thresholds

Schedule 3 Price disclosure price reduction thresholds

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 2016, and the data collection period for a related brand ends on 30 September 2016:

(a)    the first data collection period starts on 1 July 2016; and

(b)    the first data collection period ends on 30 September 2016; and

(c)    subsequent data collection periods will be the 6 month periods that start on 1 October 2016, 1 April 2017, 1 October 2017 and so on.

Example 2: If a brand to which subsection (3) applies has a start day of 1 August 2016:

(a)    the first data collection period starts on 1 August 2016; and

(b)    the first data collection period ends on 31 March 2017; and

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

Example 3: If a brand to which subsection (3) applies has a start day of 1 December 2016:

(a)    the first data collection period starts on 1 December 2016; and

(b)    the first data collection period ends on 30 September 2017; and

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

3  Paragraph 99ADH(1)(a)

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

4  Paragraph 99ADH(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 99ADH(2)

Insert:

          (2A)  For the purposes of paragraph (1)(c), the 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 pharmaceutical item as, or was bioequivalent or biosimilar to, the WADP brand; or

                             (ii)  there were 2 or more related brands of the WADP brand that had the same pharmaceutical item as, or were bioequivalent or biosimilar to, each other.

6  Subsection 99ADH(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.

Part 2 Amendments commencing 1 July 2022

National Health Act 1953

8  Subsection 99ADB(1)

Repeal the following definitions:

                     (a)  definition of data collection period ;

                     (b)  definition of related brand ;

                     (c)  definition of start day .

9  Section 99ADBA

Repeal the section.

10  Paragraph 99ADH(1)(a)

Omit “(the WADP brand ) in respect of a data collection period for the brand”.

11  Paragraph 99ADH(1)(c)

Repeal the paragraph, substitute:

                     (c)  the unadjusted price reduction for the brand of the pharmaceutical item is at least 10%.

12  Subsection 99ADH(2A)

Repeal the subsection.