Part 1 -- Amendments commencing day after Royal A ssent
1 Section 99AC
Omit:
(b) arise if a pharmaceutical item has had a drug on F1 for 5 years on a particular day.
substitute:
(b) occur on a particular day if , on that day, the pharmaceutical item has a drug on F1 and that drug has been a listed drug for at least 5 years, 10 years or 15 years.
Price reductions for listed brands of pharmaceutical items under this Division are subject to:
(a) determinations made by the Minister to not apply, or reduce, the price reduction; or
(b) price reductions made under Subdivision E of Division 3B (see section 99ACG).
2 Subsection 99ACF(1) (heading)
Repeal the heading, substitute:
Reduction equal to percentage etc.
3 Paragraph 9 9ACF(1)(a)
After "section" (wherever occurring), insert "or subsection".
4 Subsection 99ACF(1)
Omit " subsection ( 2A)", substitute " subsections ( 2 A ) and (3) ".
5 Subsection 99ACF(1)
Omit " by the percentage specified in column 3 of the table for the section", substitute " by the percentage or method specified in column 3 of the table for the section or subsection ".
6 Subsection 99ACF(1) (table, heading to column headed "Section")
Repeal the heading, substitute:
Section or subsection
7 Subsection 99ACF(1) (table, heading to column headed "Percentage")
Repeal the heading, substitute:
Percentage or method
8 Subsection 99ACF(1) (at the end of the table)
Add:
3 | 99ACJ | 10% |
4 | 99ACK | 5% |
5 | 99ACL(1) | 10% |
6 | 99ACL (2 ) | (a) first, 10%; and (b) second, using the price worked out under paragraph ( a), by 5% |
9 Paragraph 9 9ACF(2)(a)
After "section", insert "or subsection".
10 Paragraphs 99ACF(2)(b) and (c)
Omit "the percentage specified in column 3 of the table for the section", substitute "the percentage or method specified in column 3 of the table for the section or subsection".
11 Before subsection 99ACF(4)
Insert:
Ministerial discretion not to apply, or to reduce, statutory price reduction
(3) In relation to a listed brand of a pharmaceutical item, t he Minister may, by written instrument, determine that:
(a) the approved ex - manufacturer price is, or (if applicable) one or more claimed prices are, not to be reduced under a provision mentioned in items 2 to 6 of the table in subsection ( 1) (the specified provision ) in relation to a particular reduction day; or
(b) the approved ex - manufacturer price is, or (if applicable) one or more of the claimed prices are, to be reduced by a lower percentage than would otherwise apply under a provision mentioned in items 2 to 6 of the table in subsection ( 1) (the specified provision ) in relation to a particular reduction day .
(3A) In making a determination in relation to the application of item 2 , 3, 4, 5, or 6 of the table in subsection ( 1):
(a) the Minister must take into account what the approved ex - manufacturer price , and (if applicable) each of the claimed prices , of the listed brand of the pharmaceutical item would otherwise be under this section in relation to the particular reduction day if a determination were not made; and
(b) the Minister may take into account any other matter that the Minister considers relevant.
(3 B ) If the Minister makes a determination in relation to a specified provision , the approved ex - manufacturer price is, and (if applicable) each of the claimed prices are, not to be further reduced under that specified provision on any reduction day that occurs after the reduction day specified in the determination made under subsection ( 3).
12 Subsection 99ACF(4)
Omit "after the reduction day", substitute "on or after the reduction day".
13 Paragraph 9 9ACG(b)
Omit "this subsection", substitute "this section".
14 Section 99ACHA (heading)
Repeal the heading, substitute:
99ACHA 5% statutory price reduction for drugs on F1--fifth anniversary
15 Paragraph 9 9ACHA(1)(b)
Repeal the paragraph, substitute:
(b) the 5% price reduction day is on or after th e fifth anniversary of the drug being a listed drug ; and
16 Paragraph 9 9ACHA(1)(c)
Omit " this Subdivision", substitute "subsection 99ACF(1) or (2) because of item 1 in the table in section 99ACF".
17 At the end of subsection 99ACHA(2)
Add:
; (f) 1 April 2021;
(g) 1 April 2022.
18 At the end of Division 3A of Part VII
Add:
99ACJ 10% statutory price reduction for drugs on F1--tenth anniversary
(1) This section applies to a brand of a pharmaceutical item on a 10% price reduction day if:
(a) the drug in the pharmaceutical item is on F1 on the 10% price reduction day; and
(b) the 10% price reduction day is on or after the tenth anniversary of the drug being a listed drug ; and
(c) the approved ex - manufacturer price of a brand of a pharmaceutical item that has the drug, on the day before the 10% price reduction day, has not been reduced under s ubs ection 99ACF(1) or (2) because of:
(i) item 3 in the table in section 99ACF on a previous 10% price reduction day; or
(ii) item 5 in the table in section 99ACF on 1 June 2018.
(2) In this section, each of the following is a 10% price reduction day :
(a) 1 April 2019;
(b) 1 April 2020;
(c) 1 April 2021.
99ACK 5% statutory price reduction for drugs on F1--15th anniversary
(1) This section applies to a brand of a pharmaceutical item on a 5% price reduction day if:
(a) the drug in the pharmaceutical item is on F1 on the 5% price reduction day; and
(b) the 5% price reduction day is on or after the 15th anniversary of the drug being a listed drug ; and
(c) the approved ex - manufacturer price of a brand of a pharmaceutical item that has the drug, on the day before the 5% price reduction day, has not been reduced under s ubs ection 99ACF(1) or (2) because of:
(i) item 4 in the table in section 99ACF on a previous 5% price reduction day; or
(ii) item 6 in the table in section 99ACF on 1 June 2018.
(2) In this section, each of the following is a 5% price reduction day :
(a) 1 April 2019;
(b) 1 April 2020;
(c) 1 April 2021.
99ACL Special rule--statutory price reduction for drugs on F1
Tenth anniversary of listing of drug falls on or before 1 June 2018
(1) This subsection applies to a brand of a pharmaceutical item i f:
(a) the drug in the pharmaceutical item is on F1 on 1 June 2018 (the price reduction day ); and
(b) the price red uction day is on or after the ten th anniversary of the drug being a listed drug; and
(c) subsection ( 2) is not satisfied in relation to the brand of the pharmaceutical item .
15th anniversary of listing of drug falls on or before 1 June 2018
(2) This subsection applies to a brand of a pharmaceutical item if:
(a) the drug in the pharmaceutical item is on F1 on 1 June 2018 (the price reduction day ); and
(b) the price reduction day is on or after the 15th anniversary of the drug being a listed drug.