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This is a Bill, not an Act. For current law, see the Acts databases.
2019-2020-2021
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
National Health Amendment (Enhancing
the Pharmaceutical Benefits Scheme) Bill
2021
No. , 2021
(Health)
A Bill for an Act to amend the National Health Act
1953, and for other purposes
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Amendments
3
Part 1--Amendments commencing on the day after Royal
Assent
3
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Act 2018
3
Part 2--Amendments commencing on 1 July 2022
4
National Health Act 1953
4
Part 3--Amendments commencing on 1 October 2022
36
National Health Act 1953
36
Part 4--Amendments commencing on 1 July 2023
41
National Health Act 1953
41
Part 5--Amendments commencing on 1 July 2027
47
National Health Act 1953
47
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
1
A Bill for an Act to amend the National Health Act
1
1953, and for other purposes
2
The Parliament of Australia enacts:
3
1 Short title
4
This Act is the
National Health Amendment (Enhancing the
5
Pharmaceutical Benefits Scheme) Act 2021
.
6
2 Commencement
7
(1) Each provision of this Act specified in column 1 of the table
8
commences, or is taken to have commenced, in accordance with
9
column 2 of the table. Any other statement in column 2 has effect
10
according to its terms.
11
12
2
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
Commencement information
Column 1
Column 2
Column 3
Provisions
Commencement
Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day this Act receives the Royal Assent.
2. Schedule 1,
Part 1
The day after this Act receives the Royal
Assent.
3. Schedule 1,
Part 2
1 July 2022.
1 July 2022
4. Schedule 1,
Part 3
1 October 2022.
1 October 2022
5. Schedule 1,
Part 4
1 July 2023.
1 July 2023
6. Schedule 1,
Part 5
1 July 2027.
1 July 2027
Note:
This table relates only to the provisions of this Act as originally
1
enacted. It will not be amended to deal with any later amendments of
2
this Act.
3
(2) Any information in column 3 of the table is not part of this Act.
4
Information may be inserted in this column, or information in it
5
may be edited, in any published version of this Act.
6
3 Schedules
7
Legislation that is specified in a Schedule to this Act is amended or
8
repealed as set out in the applicable items in the Schedule
9
concerned, and any other item in a Schedule to this Act has effect
10
according to its terms.
11
Amendments
Schedule 1
Amendments commencing on the day after Royal Assent
Part 1
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
3
Schedule 1--Amendments
1
Part 1--Amendments commencing on the day after
2
Royal Assent
3
National Health Amendment (Pharmaceutical Benefits--
4
Budget and Other Measures) Act 2018
5
1 Part 2 of Schedule 1
6
Repeal the Part.
7
2 Part 2 of Schedule 2
8
Repeal the Part.
9
3 Part 2 of Schedule 3
10
Repeal the Part.
11
3A Part 2 of Schedule 4
12
Repeal the Part.
13
Schedule 1
Amendments
Part 2
Amendments commencing on 1 July 2022
4
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
Part 2--Amendments commencing on 1 July 2022
1
National Health Act 1953
2
4 Subsection 84(1) (at the end of the definition of approved
3
ex-manufacturer price)
4
Add:
5
Note:
See also section 85BA (effect of deemed reductions of, or increases
6
to, the approved ex-manufacturer price).
7
5 After section 85B
8
Insert:
9
85BA Effect of deemed reductions of, or increases to, approved
10
ex-manufacturer price
11
(1) If, under a provision of this Part, the approved ex-manufacturer
12
price of a brand of a pharmaceutical item is, or is taken to be,
13
reduced by an amount (the
reduction amount
) or a percentage (the
14
reduction percentage
):
15
(a) in a case where a price agreement is in force in relation to the
16
brand of the pharmaceutical item--the amount in force under
17
the agreement as the amount that is, for the purposes of this
18
Part, taken to be the appropriate maximum price of the brand
19
of the pharmaceutical item is taken to be reduced by the
20
reduction amount or the reduction percentage, as the case
21
requires; or
22
(b) in a case where a price determination is in force in relation to
23
the brand of the pharmaceutical item--the amount in force
24
under the determination as the amount that is, for the
25
purposes of this Part, taken to be the appropriate maximum
26
price of the brand of the pharmaceutical item is taken to be
27
reduced by the reduction amount or the reduction percentage,
28
as the case requires.
29
(2) If, under a provision of this Part, the approved ex-manufacturer
30
price of a brand of a pharmaceutical item is, or is taken to be,
31
Amendments
Schedule 1
Amendments commencing on 1 July 2022
Part 2
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
5
increased by an amount (the
increase amount
) or a percentage (the
1
increase percentage
):
2
(a) in a case where a price agreement is in force in relation to the
3
brand of the pharmaceutical item--the amount in force under
4
the agreement as the amount that is, for the purposes of this
5
Part, taken to be the appropriate maximum price of the brand
6
of the pharmaceutical item is taken to be increased by the
7
increase amount or the increase percentage, as the case
8
requires; or
9
(b) in a case where a price determination is in force in relation to
10
the brand of the pharmaceutical item--the amount in force
11
under the determination as the amount that is, for the
12
purposes of this Part, taken to be the appropriate maximum
13
price of the brand of the pharmaceutical item is taken to be
14
increased by the increase amount or the increase percentage,
15
as the case requires.
16
6 Section 9
9AC (paragraph beginning "Subdivision B")
17
Repeal the paragraph, substitute:
18
Subdivision B requires there to be a price reduction for the first
19
new brand of a pharmaceutical item (other than a combination
20
item) when the brand lists. The listing of the new brand of the
21
pharmaceutical item also provides an automatic trigger for price
22
reductions to occur under Subdivision E (see sections 99ACQ and
23
99ACR).
24
7 Section 9
9AC (paragraph beginning "Subdivision C")
25
Repeal the paragraph, substitute:
26
Subdivision C requires there to be a price reduction for the first
27
new brand of a pharmaceutical item that is a combination item
28
when the brand lists. The listing of the new brand of the
29
pharmaceutical item also provides an automatic trigger for price
30
reductions to occur under Subdivision E (see sections 99ACQ and
31
99ACR).
32
Schedule 1
Amendments
Part 2
Amendments commencing on 1 July 2022
6
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
8 Section 9
9AC (paragraph beginning "Subdivision D")
1
Repeal the paragraph, substitute:
2
Subdivision D provides for other price reductions for
3
pharmaceutical items. These price reductions include reductions
4
that occur on a certain anniversary of the drug in the
5
pharmaceutical item being a listed drug.
6
Subdivision E provides for price reductions that are automatically
7
triggered when Subdivision B or C applies to require a first new
8
brand price reduction for a brand of a pharmaceutical item.
9
9 At the end of section 99ACA
10
Add:
11
(4) A reference in this Division to the approved ex-manufacturer price
12
of a brand of a pharmaceutical item being reduced under
13
subsection 99ACF(2) is to be read as a reference to that subsection
14
applying to the brand of the pharmaceutical item.
15
10 Subdivision B of Division 3A of Part VII (heading)
16
Omit "
25% price reductions for new
", substitute "
First new brand
17
price reductions for
".
18
11 Section 99ACB (heading)
19
Omit "
25% price reduction for new
", substitute "
First new brand
20
price reductions for
".
21
12 Paragraph 99ACB(2)(d)
22
Omit "40%", substitute "60%".
23
13 After subsection 99ACB(2)
24
Insert:
25
(2A) If the approved ex-manufacturer price mentioned in
26
subparagraph (2)(d)(i) or (ii) is by reference to a different pricing
27
quantity than the pricing quantity on the day before the
28
determination day, the approved ex-manufacturer price mentioned
29
Amendments
Schedule 1
Amendments commencing on 1 July 2022
Part 2
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
7
in that subparagraph is taken to be the amount that the approved
1
ex-manufacturer price would have been had the pricing quantity
2
been the same as the pricing quantity on the day before the
3
determination day.
4
14 Subparagraph 99ACB(3)(a)(i)
5
Repeal the subparagraph, substitute:
6
(i) subsection (5) or (5A);
7
(ia) a determination under paragraph (6A)(b);
8
(ib) subsection 99ACF(1) or (2) because of item 4A, 4B or 8
9
in the table in subsection 99ACF(1);
10
15 Subparagraph 99ACB(3)(a)(ii)
11
Before "section 99ACH", insert "repealed".
12
16 Subparagraph 99ACB(3)(a)(iii)
13
Before "subsection", insert "repealed".
14
17 At the end of paragraph 99ACB(3)(a)
15
Add:
16
(iv) section 99ACQ;
17
(v) subsection 99ACR(3) or (4);
18
18 Subsection 99ACB(3) (note)
19
Omit "subsection (1) is", substitute "subsections (5) and (5A) of this
20
section are".
21
19 Subsection 99ACB(3) (note)
22
After "99AEI", insert " and subsection (6B) of this section".
23
20 Subsection 99ACB(4) (heading)
24
Omit "
25%
", substitute "
First new brand
".
25
21 Paragraphs 99ACB(4A)(c) and (d)
26
Omit "15%", substitute "35%".
27
Schedule 1
Amendments
Part 2
Amendments commencing on 1 July 2022
8
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
22 Paragraph 99ACB(4A)(d)
1
Omit "40%", substitute "60%".
2
23 Subsection 99ACB(4A) (note)
3
Omit "40%", substitute "60%".
4
24 After subsection 99ACB(4A)
5
Insert:
6
(4B) If the approved ex-manufacturer price mentioned in
7
paragraph (4A)(a) or (b) is by reference to a different pricing
8
quantity than the pricing quantity on the day before the
9
determination day, the approved ex-manufacturer price mentioned
10
in that paragraph is taken to be the amount that the approved
11
ex-manufacturer price would have been had the pricing quantity
12
been the same as the pricing quantity on the day before the
13
determination day.
14
25 Subsection 99ACB(5A)
15
Omit "(6B)", substitute "(6A)".
16
26 Paragraphs 99ACB(5A)(a) and (b)
17
Omit "60%", substitute "40%".
18
27 After subsection 99ACB(5A)
19
Insert:
20
(5B) If the approved ex-manufacturer price mentioned in
21
paragraph (5A)(a) or (b) is by reference to a different pricing
22
quantity than the pricing quantity on the day before the
23
determination day, the approved ex-manufacturer price mentioned
24
in that paragraph is taken to be the amount that the approved
25
ex-manufacturer price would have been had the pricing quantity
26
been the same as the pricing quantity on the day before the
27
determination day.
28
28 Subsections 99ACB(6A) and (6B)
29
Repeal the subsections, substitute:
30
Amendments
Schedule 1
Amendments commencing on 1 July 2022
Part 2
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
9
Ministerial discretion not to apply, or to reduce, statutory price
1
reduction
2
(6A) The Minister may, by notifiable instrument, determine that:
3
(a) the agreed price of the new brand of the trigger item that
4
comes into force on the determination day is to be equal to
5
the approved ex-manufacturer price, on the day before the
6
determination day, of the existing brand of the existing item;
7
or
8
(b) the agreed price of the new brand of the trigger item that
9
comes into force on the determination day must not exceed
10
the approved ex-manufacturer price, on the day before the
11
determination day, of the existing brand of the existing item,
12
reduced by a lower percentage than would otherwise result
13
from the operation of subsection (5) or (5A) in relation to the
14
determination day.
15
(6B) If the Minister makes a determination under paragraph (6A)(a),
16
subsections (5) and (5A) are taken not to have applied to the trigger
17
item.
18
29 Subsection 99ACB(6C)
19
Omit "or (6B)".
20
30 Subsection 99ACB(6D)
21
Repeal the subsection.
22
31 Paragraph 99ACC(1)(c)
23
Omit "an agreed price (the
existing agreed price
) is in force", substitute
24
"there is an approved ex-manufacturer price".
25
32 Paragraph 99ACC(1)(d)
26
Omit "after the day on which the existing agreed price came into force
27
for the single brand of the combination item:", substitute "any of the
28
following apply:".
29
33 Subsections 99ACC(2) to (5)
30
Repeal the subsections, substitute:
31
Schedule 1
Amendments
Part 2
Amendments commencing on 1 July 2022
10
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
Price reduction
1
(2) Subject to subsections (5A), (5C) and (5E), on the reduction day,
2
the approved ex-manufacturer price of the single brand of the
3
combination item is taken to be reduced in accordance with a
4
method prescribed by the regulations.
5
(3) Different methods may be prescribed by the regulations for
6
different classes of combination items.
7
(4) Subsection (3) does not limit subsection 33(3A) of the
Acts
8
Interpretation Act 1901
.
9
(5) Subject to subsections (5A) and (5C), if the approved
10
ex-manufacturer price of the single brand of the combination item
11
is reduced under subsection (2), then, on the reduction day, the
12
claimed price (if any) of the single brand of the combination item
13
is taken to be reduced by a percentage equal to the percentage by
14
which the approved ex-manufacturer price of the single brand of
15
the combination item is reduced under subsection (2).
16
Reduction cap
17
(5A) If:
18
(a) the approved ex-manufacturer price of the single brand of the
19
combination item is to be reduced under subsection (2); and
20
(b) apart from this subsection, the reduced approved
21
ex-manufacturer price would be less than the amount (the
22
capped price
) equal to:
23
(i) 40% of the approved ex-manufacturer price of a listed
24
brand of the combination item on 1 January 2016; or
25
(ii) if subparagraph (i) does not apply--40% of the original
26
approved ex-manufacturer price of the first listed brand
27
of the combination item;
28
the approved ex-manufacturer price of the single brand of the
29
combination item is taken to be reduced under subsection (2) to an
30
amount equal to the capped price.
31
(5B) If the approved ex-manufacturer price mentioned in
32
subparagraph (5A)(b)(i) or (ii) is by reference to a different pricing
33
quantity than the pricing quantity on the reduction day, the
34
Amendments
Schedule 1
Amendments commencing on 1 July 2022
Part 2
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
11
approved ex-manufacturer price mentioned in that subparagraph is
1
taken to be the amount that the approved ex-manufacturer price
2
would have been had the pricing quantity been the same as the
3
pricing quantity on the reduction day.
4
Ministerial discretion not to apply, or to reduce, statutory price
5
reduction
6
(5C) In relation to the single brand of the combination item, the Minister
7
may, by notifiable instrument, determine that:
8
(a) the approved ex-manufacturer price, and (if applicable) the
9
claimed price, is not to be reduced under subsection (2) or
10
(5), as the case requires, in relation to a particular reduction
11
day; or
12
(b) the approved ex-manufacturer price, and (if applicable) the
13
claimed price, is to be reduced by a lower percentage than
14
would otherwise apply under subsection (2) or (5), as the
15
case requires, in relation to a particular reduction day.
16
(5D) In making a determination under subsection (5C):
17
(a) the Minister must take into account what the approved
18
ex-manufacturer price, and (if applicable) the claimed price,
19
of the single brand of the combination item would otherwise
20
be under this section in relation to the particular reduction
21
day if a determination were not made; and
22
(b) the Minister may take into account:
23
(i) any advice given to the Minister under
24
subsection 101(4AC) in relation to the combination
25
item; and
26
(ii) any other matter the Minister thinks is relevant.
27
(5E) If the Minister makes a determination under subsection (5C), the
28
approved ex-manufacturer price of the single brand of the
29
combination item is not to be further reduced under this section on
30
any reduction day that occurs after the reduction day specified in
31
the determination made under subsection (5C).
32
Section does not limit Minister's powers
33
(5F) This section does not limit the Minister's powers, on or after the
34
reduction day, to make:
35
Schedule 1
Amendments
Part 2
Amendments commencing on 1 July 2022
12
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
(a) further price agreements; or
1
(b) determinations under section 85B;
2
for the single brand of the combination item.
3
34 Paragraph 99ACC(6)(a)
4
Omit "or 99ADH, or subsection 99ACF(1), (2), (2AB) or (2AC)
5
because of section 99ACH,", substitute "or 99ACQ or
6
subsection 99ACR(3) or (4) or section 99ADH".
7
35 Paragraph 99ACC(6)(c)
8
Omit "item 2, 3, 4, 5 or 6", substitute "an item".
9
36 Section 99ACD (heading)
10
Omit "
25% price reduction for new
", substitute "
First new brand
11
price reductions for
".
12
37 Paragraph 99ACD(1A)(d)
13
Omit "40%", substitute "60%".
14
38 After subsection 99ACD(1A)
15
Insert:
16
(1B) If the approved ex-manufacturer price mentioned in
17
subparagraph (1A)(d)(i) or (ii) is by reference to a different pricing
18
quantity than the pricing quantity on the day before the
19
determination day, the approved ex-manufacturer price mentioned
20
in that subparagraph is taken to be the amount that the approved
21
ex-manufacturer price would have been had the pricing quantity
22
been the same as the pricing quantity on the day before the
23
determination day.
24
39 Subsection 99ACD(2)
25
Omit "subsection (1) or section 99ACE", substitute "a listed provision
26
(see subsection (2A))".
27
40 Subsection 99ACD(2) (note)
28
Omit "subsection (1) is", substitute "subsections (5) and (5A) of this
29
section are".
30
Amendments
Schedule 1
Amendments commencing on 1 July 2022
Part 2
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
13
41 Subsection 99ACD(2) (note)
1
After "99AEI", insert " and subsection (7B) of this section".
2
42 After subsection 99ACD(2)
3
Insert:
4
(2A) For the purposes of subsection (2),
listed provision
means:
5
(a) subsection (5) or (5A); or
6
(b) a determination under paragraph (7A)(b); or
7
(c) subsection 99ACF(1) or (2) because of item 4A, 4B or 8 in
8
the table in subsection 99ACF(1); or
9
(d) section 99ACQ; or
10
(e) subsection 99ACR(3) or (4); or
11
(f) repealed section 99ACE.
12
43 Subsection 99ACD(4) (heading)
13
Omit "
25%
", substitute "
First new brand
".
14
44 Paragraphs 99ACD(4A)(c) and (d)
15
Omit "15%", substitute "35%".
16
45 Paragraph 99ACD(4A)(d)
17
Omit "40%", substitute "60%".
18
46 Subsection 99ACD(4A) (note)
19
Omit "40%", substitute "60%".
20
47 After subsection 99ACD(4A)
21
Insert:
22
(4B) If the approved ex-manufacturer price mentioned in
23
paragraph (4A)(a) or (b) is by reference to a different pricing
24
quantity than the pricing quantity on the day before the
25
determination day, the approved ex-manufacturer price mentioned
26
in that paragraph is taken to be the amount that the approved
27
ex-manufacturer price would have been had the pricing quantity
28
been the same as the pricing quantity on the day before the
29
determination day.
30
Schedule 1
Amendments
Part 2
Amendments commencing on 1 July 2022
14
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
48 Subsection 99ACD(5A)
1
Omit "(7B)", substitute "(7A)".
2
49 Paragraphs 99ACD(5A)(a) and (b)
3
Omit "60%", substitute "40%".
4
50 After subsection 99ACD(5A)
5
Insert:
6
(5B) If the approved ex-manufacturer price mentioned in
7
paragraph (5A)(a) or (b) is by reference to a different pricing
8
quantity than the pricing quantity on the day before the
9
determination day, the approved ex-manufacturer price mentioned
10
in that paragraph is taken to be the amount that the approved
11
ex-manufacturer price would have been had the pricing quantity
12
been the same as the pricing quantity on the day before the
13
determination day.
14
51 Subsections 99ACD(7A) and (7B)
15
Repeal the subsections, substitute:
16
Ministerial discretion not to apply, or to reduce, statutory price
17
reduction
18
(7A) The Minister may, by notifiable instrument, determine that:
19
(a) the agreed price of the new brand of the trigger combination
20
item that comes into force on the determination day is to be
21
equal to the approved ex-manufacturer price, on the day
22
before the determination day, of the existing brand of the
23
existing item; or
24
(b) the agreed price of the new brand of the trigger combination
25
item that comes into force on the determination day must not
26
exceed the approved ex-manufacturer price, on the day
27
before the determination day, of the existing brand of the
28
existing item, reduced by a lower percentage than would
29
otherwise result from the operation of subsection (5) or (5A)
30
in relation to the determination day.
31
Amendments
Schedule 1
Amendments commencing on 1 July 2022
Part 2
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
15
(7B) If the Minister makes a determination under paragraph (7A)(a),
1
subsections (5) and (5A) are taken not to have applied to the trigger
2
combination item.
3
52 Subsection 99ACD(7C)
4
Omit "or (7B)".
5
53 Subsection 99ACD(7D)
6
Repeal the subsection.
7
54 Section 99ACE
8
Repeal the section.
9
55 Subsection 99ACF(1)
10
Omit "section 99ACG", substitute "sections 99ACG and 99ADHC".
11
56 Subsection 99ACF(1)
12
After "subject to subsections", insert "(1A),".
13
57 Subsection 99ACF(1) (after table item 2)
14
Insert:
15
2A
99ACHB
5%
58 Subsection 99ACF(1) (after table item 3)
16
Insert:
17
3A
99ACJA
5%
59 Subsection 99ACF(1) (after table item 4)
18
Insert:
19
4A
99ACKA
26.1%
4B
99ACKB
30%
60 Subsection 99ACF(1) (at the end of the table)
20
Add:
21
7
99ACM
5%
8
99ACN
The percentage referred to in
paragraph 99ACN(1)(c)
Schedule 1
Amendments
Part 2
Amendments commencing on 1 July 2022
16
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
9
99ACP
1.48%
61 After subsection 99ACF(1)
1
Insert:
2
Reduction cap
3
(1A) If:
4
(a) the approved ex-manufacturer price of a listed brand of a
5
pharmaceutical item is to be reduced under subsection (1)
6
because of an item in the table in subsection (1); and
7
(b) apart from this subsection, the reduced approved
8
ex-manufacturer price would be less than the amount (the
9
capped price
) equal to:
10
(i) 40% of the approved ex-manufacturer price of a listed
11
brand of the pharmaceutical item on 1 January 2016; or
12
(ii) if subparagraph (i) does not apply--40% of the original
13
approved ex-manufacturer price of the first listed brand
14
of the pharmaceutical item;
15
the approved ex-manufacturer price of the listed brand of the
16
pharmaceutical item is taken to be reduced under subsection (1)
17
because of that item to an amount equal to the capped price.
18
(1B) If the approved ex-manufacturer price mentioned in
19
subparagraph (1A)(b)(i) or (ii) is by reference to a different pricing
20
quantity than the pricing quantity on the reduction day, the
21
approved ex-manufacturer price mentioned in that subparagraph is
22
taken to be the amount that the approved ex-manufacturer price
23
would have been had the pricing quantity been the same as the
24
pricing quantity on the reduction day.
25
62 Paragraph 99ACF(2)(b)
26
Repeal the paragraph, substitute:
27
(b) subject to subsection (2A), on the reduction day, the
28
approved ex-manufacturer price of the listed brand of the
29
pharmaceutical item does not exceed:
30
(i) the approved ex-manufacturer price of the brand of the
31
pharmaceutical item in force on the day before the
32
reduction day, reduced by more than the percentage or
33
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method specified in column 3 of the table for the section
1
or subsection referred to in column 2; or
2
(ii) if subsection (1A) would have applied to the brand of
3
the pharmaceutical item if paragraph (1)(b) were
4
disregarded--the capped price of the brand of the
5
pharmaceutical item that would be worked under
6
subsection (1A) if paragraph (1)(b) were disregarded;
7
and
8
63 Subsections 99ACF(2AA) to (2AC)
9
Repeal the subsections.
10
64 Subsection 99ACF(2A)
11
Omit ", paragraph (2)(b) and subsections (2AB) and (2AC)", substitute
12
"and paragraph (2)(b)".
13
64A Subsection 99ACF(3)
14
Omit "written instrument", substitute "notifiable instrument".
15
65 Paragraphs 99ACF(3)(a) and (b)
16
Omit "items 2 to 6", substitute "an item".
17
66 Subsections 99ACF(3AA) and (3AB)
18
Repeal the subsections.
19
67 Subsection 99ACF(3A)
20
Omit ", or subsection (2AB) or paragraphs (2AC)(a) and (b)".
21
68 Subsection 99ACF(3B)
22
Omit ", (3AA) or (3AB)".
23
69 Subparagraph 99ACG(b)(ii)
24
Omit "or 99ACE".
25
70 Subparagraphs 99ACG(b)(iii) and (iv)
26
Repeal the subparagraphs, substitute:
27
(iii) subsection 99ACF(1) or (2) because of item 4A, 4B, 7,
28
8 or 9 in the table in subsection 99ACF(1);
29
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(iv) section 99ACQ;
1
(v) subsection 99ACR(3) or (4);
2
71 Section 99ACH
3
Repeal the section.
4
72 Paragraph 99ACHA(1)(c)
5
Before "section 99ACH", insert "repealed".
6
73 After section 99ACHA
7
Insert:
8
99ACHB 5% statutory price reduction for drugs on F1--fifth
9
anniversary
10
(1) This section applies to a brand of a pharmaceutical item on a 5%
11
price reduction day if:
12
(a) the drug in the pharmaceutical item is on F1 on the 5% price
13
reduction day; and
14
(b) the 5% price reduction day is on or after the fifth anniversary
15
of the drug being a listed drug; and
16
(c) subsection 99ACR(4) has not applied to the brand of the
17
pharmaceutical item; and
18
(d) on or before the 5% price reduction day, the approved
19
ex-manufacturer price of the brand of the pharmaceutical
20
item has not been reduced:
21
(i) under subsection 99ACF(1) or (2); or
22
(ii) because of repealed section 99ACE or repealed
23
section 99ACH; or
24
(iii) under section 99ACQ; or
25
(iv) under subsection 99ACR(3).
26
(2) In this section, each of the following is a
5% price reduction day
:
27
(a) 1 April 2023;
28
(b) 1 April 2024;
29
(c) 1 April 2025;
30
(d) 1 April 2026;
31
(e) 1 April 2027.
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74 After section 99ACJ
1
Insert:
2
99ACJA 5% statutory price reduction for drugs on F1--tenth
3
anniversary
4
(1) This section applies to a brand of a pharmaceutical item on a 5%
5
price reduction day if:
6
(a) the drug in the pharmaceutical item is on F1 on the 5% price
7
reduction day; and
8
(b) the 5% price reduction day is on or after the tenth anniversary
9
of the drug being a listed drug; and
10
(c) the approved ex-manufacturer price of the brand of the
11
pharmaceutical item has not been previously reduced under
12
subsection 99ACF(1) or (2) because of:
13
(i) item 3 in the table in section 99ACF; or
14
(ii) item 3A in the table in section 99ACF; or
15
(iii) item 5 in the table in section 99ACF; or
16
(iv) item 7 in the table in section 99ACF; and
17
(d) subsection 99ACR(4) has not applied to the brand of the
18
pharmaceutical item; and
19
(e) on or before the 5% price reduction day, the approved
20
ex-manufacturer price of the brand of the pharmaceutical
21
item has not been previously reduced:
22
(i) because of repealed section 99ACE or repealed
23
section 99ACH; or
24
(ii) under section 99ACQ; or
25
(iii) under subsection 99ACR(3).
26
(2) In this section, each of the following is a
5% price reduction day
:
27
(a) 1 April 2023;
28
(b) 1 April 2024;
29
(c) 1 April 2025;
30
(d) 1 April 2026;
31
(e) 1 April 2027.
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75 After section 99ACK
1
Insert:
2
99ACKA 26.1% statutory price reduction for certain drugs--15th
3
anniversary
4
(1) This section applies to a brand of a pharmaceutical item on a
5
26.1% price reduction day if:
6
(a) the 26.1% price reduction day is on or after the 15th
7
anniversary of the drug in the pharmaceutical item being a
8
listed drug; and
9
(b) the approved ex-manufacturer price of the brand of the
10
pharmaceutical item has not been previously reduced under
11
subsection 99ACF(1) or (2) because of:
12
(i) item 4 in the table in section 99ACF; or
13
(ii) item 4A in the table in section 99ACF; or
14
(iii) item 6 in the table in section 99ACF; or
15
(iv) item 8 in the table in section 99ACF; and
16
(c) the approved ex-manufacturer price of the brand of the
17
pharmaceutical item has not been reduced on or before the
18
26.1% price reduction day:
19
(i) because of section 99ACB or 99ACD; or
20
(ii) because of repealed section 99ACE or repealed
21
section 99ACH; or
22
(iii) under section 99ACQ; or
23
(iv) under subsection 99ACR(3); and
24
(d) subsection 99ACR(4) has not applied to the brand of the
25
pharmaceutical item on or before the 26.1% price reduction
26
day; and
27
(e) the pharmaceutical item is not an exempt item.
28
Note:
See also section 99ACG.
29
(2) In this section, each of the following is a
26.1% price reduction
30
day
:
31
(a) 1 April 2023;
32
(b) 1 April 2024;
33
(c) 1 April 2025;
34
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(d) 1 April 2026.
1
99ACKB 30% statutory price reduction for certain drugs--15th
2
anniversary
3
(1) This section applies to a brand of a pharmaceutical item on the
4
30% price reduction day if:
5
(a) the 30% price reduction day is on or after the 15th
6
anniversary of the drug in the pharmaceutical item being a
7
listed drug; and
8
(b) the approved ex-manufacturer price of the brand of the
9
pharmaceutical item has not been previously reduced under
10
subsection 99ACF(1) or (2) because of:
11
(i) item 4 in the table in section 99ACF; or
12
(ii) item 4A in the table in section 99ACF; or
13
(iii) item 6 in the table in section 99ACF; or
14
(iv) item 8 in the table in section 99ACF; and
15
(c) the approved ex-manufacturer price of the brand of the
16
pharmaceutical item has not been reduced on or before the
17
30% price reduction day:
18
(i) because of section 99ACB or 99ACD; or
19
(ii) because of repealed section 99ACE or repealed
20
section 99ACH; or
21
(iii) under section 99ACQ; or
22
(iv) under subsection 99ACR(3); and
23
(d) subsection 99ACR(4) has not applied to the brand of the
24
pharmaceutical item on or before the 30% price reduction
25
day; and
26
(e) the pharmaceutical item is not an exempt item.
27
Note:
See also section 99ACG.
28
(2) In this section, the
30% price reduction day
is 1 April 2027.
29
76 At the end of Division 3A of Part VII
30
Add:
31
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99ACM 5% statutory price reduction for drugs on F1--tenth
1
anniversary
2
(1) This section applies to a brand of a pharmaceutical item on a 5%
3
price reduction day if:
4
(a) the drug in the pharmaceutical item is on F1 on the 5% price
5
reduction day; and
6
(b) the tenth anniversary of the drug being a listed drug occurred
7
during the period:
8
(i) beginning at the start of 1 May 2021; and
9
(ii) ending at the end of 1 April 2022.
10
Note:
See also section 99ACG.
11
(2) In this section, the
5% price reduction day
is 1 April 2023.
12
99ACN Catch-up price reduction for certain drugs--15th
13
anniversary
14
(1) This section applies to a brand of a pharmaceutical item on the
15
catch-up price reduction day if:
16
(a) the 15th anniversary of the drug in the pharmaceutical item
17
being a listed drug was on or before 1 April 2022; and
18
(b) the pharmaceutical item is not an exempt item; and
19
(c) on the catch-up price reduction day, the percentage worked
20
out using the formula in subsection (2) is greater than zero.
21
Note:
See also section 99ACG.
22
(2) The formula mentioned in paragraph (1)(c) is:
23
63.18%
100%
Product of differential percentages
−
24
where:
25
product of differential percentages
means:
26
(a) if there has been only one previous price reduction under this
27
Division--the differential percentage for that price reduction;
28
or
29
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(b) if there have been 2 or more previous price reductions under
1
this Division--the product of the differential percentages for
2
those previous price reductions; or
3
(c) if there have not been any previous price reductions under
4
this Division--100%.
5
Note 1:
The effect of the formula is that, following the application of the price
6
reduction which applies as a result of this section and item 8 of the
7
table in section 99ACF(1), the cumulative impact of price reductions
8
under this Division, applied successively, will be 36.82%. For
9
example, if the brand of the pharmaceutical item has been subject to a
10
5% previous price reduction under this Division followed by a 16%
11
previous price reduction under this Division, the product of the
12
differential percentages will be (100% - 5%) x (100% - 16%) =
13
79.80%, and the percentage worked out using the formula will be
14
100% - 63.18%/79.80% = 20.83%.
15
Note 2:
For rounding of the percentage worked out using the formula, see
16
subsection (5).
17
(3) For the purposes of this section,
previous price reduction under
18
this Division
has the meaning given by section 99ACNA.
19
(4) For the purposes of this section, the
differential percentage
for a
20
previous price reduction under this Division means the difference
21
between 100% and the previous price reduction under this
22
Division.
23
(5) The percentage worked out using the formula in subsection (2) is
24
to be calculated to 2 decimal places (rounding up if the third
25
decimal place is 5 or more).
26
(6) In this section, the
catch-up price reduction day
is 1 April 2023.
27
99ACNA Catch-up price reduction for certain drugs--meaning of
28
previous price reduction under this Division
29
(1) For the purposes of the application of section 99ACN to a brand
30
(the
relevant brand
) of a pharmaceutical item,
previous price
31
reduction under this Division
means:
32
(a) a reduction, on or before the catch-up price reduction day, in
33
the approved ex-manufacturer price of the relevant brand or
34
another brand of the pharmaceutical item under this Division
35
(expressed as a percentage) (other than a reduction
36
attributable to section 99ACN); or
37
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(b) in the case of a reduction, on or before the catch-up price
1
reduction day, in the approved ex-manufacturer price of the
2
relevant brand or another brand of the pharmaceutical item
3
under subsection 99ACF(2)--the reduction in the approved
4
ex-manufacturer price of the relevant brand or the other
5
brand of the pharmaceutical item (expressed as a percentage)
6
that would have occurred under subsection 99ACF(1) if
7
paragraph (b) of that subsection were disregarded; or
8
(c) in the case of a reduction, on or before the catch-up price
9
reduction day, in the approved ex-manufacturer price of the
10
relevant brand or another brand of the pharmaceutical item
11
under subsection 99ACR(4)--the reduction in the approved
12
ex-manufacturer price of the relevant brand or the other
13
brand of the pharmaceutical item (expressed as a percentage)
14
that would have occurred under subsection 99ACR(3) if
15
subsection 99ACR(4) did not apply; or
16
(d) a 12.5% administrative price reduction that applied, on or
17
before the catch-up price reduction day, to the relevant brand
18
or another brand of the pharmaceutical item.
19
(2) For the purposes of this section:
20
(a) a reduction in the agreed price of a brand of the
21
pharmaceutical item is taken to be a reduction in the
22
approved ex-manufacturer price of the brand of the
23
pharmaceutical item; and
24
(b) a reduction in the determined price of a brand of the
25
pharmaceutical item is taken to be a reduction in the
26
approved ex-manufacturer price of the brand of the
27
pharmaceutical item; and
28
(c) a reduction before 1 October 2012 in the approved price to
29
pharmacists (within the meaning of this Part as it stood
30
before 1 October 2012) of a brand of the pharmaceutical item
31
is taken to be a reduction in the approved ex-manufacturer
32
price of the brand of the pharmaceutical item.
33
(3) A reference in this section to the approved ex-manufacturer price
34
of a brand of a pharmaceutical item being reduced under
35
subsection 99ACR(4) is to be read as a reference to that subsection
36
applying to the brand of the pharmaceutical item.
37
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(4) A reference in this section to this Division includes this Division as
1
in force at any time before the commencement of this section.
2
(5) In this section, the
catch-up price reduction day
is 1 April 2023.
3
99ACP 1.48% statutory price reduction for certain drugs--15th
4
anniversary
5
(1) This section applies to a brand of a pharmaceutical item on the
6
15th anniversary price reduction day if:
7
(a) subsection 99ACB(5) or (5A) or 99ACD(5) or (5A) or
8
section 99ACQ or subsection 99ACR(3) has applied to the
9
brand of the pharmaceutical item; and
10
(b) the approved ex-manufacturer price of the brand of the
11
pharmaceutical item has not been previously reduced under
12
subsection 99ACF(1) or (2) because of:
13
(i) item 4 in the table in section 99ACF; or
14
(ii) item 4A in the table in section 99ACF; or
15
(iii) item 8 in the table in section 99ACF; or
16
(iv) item 9 in the table in section 99ACF; and
17
(c) the item is not an exempt item.
18
Note:
See also section 99ACG.
19
(2) In this section, the
15th anniversary price reduction day
is the
20
15th anniversary of the drug in the pharmaceutical item being
21
listed as a listed drug.
22
Subdivision E--Flow-on of first new brand price reductions to
23
existing brands and related brands
24
99ACQ Flow-on of price reductions to existing brands of the same
25
pharmaceutical item
26
(1) This section applies to a brand (the
existing brand
) of a
27
pharmaceutical item if:
28
(a) subsection 99ACB(5) or (5A) or 99ACD(5) or (5A) has
29
applied to the agreed price for a brand (the
new brand
) of the
30
pharmaceutical item; and
31
(b) that price comes into force on a day (the
reduction day
); and
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(c) on the day before the reduction day, the existing brand of the
1
item was a listed brand of the item.
2
Note:
See also section 99ACG.
3
(2) On the reduction day, the approved ex-manufacturer price of the
4
existing brand of the item is taken to be reduced to an amount
5
equal to the approved ex-manufacturer price of the new brand.
6
(3) If the approved ex-manufacturer price of the existing brand of the
7
item is reduced under subsection (2), then, on the reduction day,
8
the claimed price (if any) of the existing brand is taken to be
9
reduced by a percentage equal to the percentage by which the
10
approved ex-manufacturer price of the existing brand of the item is
11
reduced under subsection (2).
12
Section does not limit Minister's powers
13
(4) This section does not limit the Minister's powers, on or after the
14
reduction day, to make:
15
(a) further price agreements; or
16
(b) determinations under section 85B;
17
for the existing brand of the item.
18
99ACR Flow-on of first new brand price reductions to related
19
brands
20
(1) This section applies to a brand (the
related brand
) of a
21
pharmaceutical item (a
related item
) mentioned in subsection (2)
22
if:
23
(a) subsection 99ACB(5) or (5A) or 99ACD(5) or (5A) has
24
applied to the agreed price for a brand (the
new brand
) of a
25
pharmaceutical item (the
new item
); and
26
(b) that price comes into force on a day (the
reduction day
); and
27
(c) on the day before the reduction day, the related brand of the
28
related item was a listed brand of the related item; and
29
(d) the related item is not an exempt item.
30
Note:
See also section 99ACG.
31
(2) For the purposes of this section, a related brand of a related item is
32
any of the following:
33
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(a) a listed brand of another pharmaceutical item that has the
1
same drug and manner of administration as the new item;
2
(b) if the drug in the new item is in a therapeutic group--a listed
3
brand of a pharmaceutical item that:
4
(i) has another drug that is in that group; and
5
(ii) has the same manner of administration as the new brand
6
of the new item.
7
(3) Subject to subsections (4) and (6), on the reduction day, the
8
approved ex-manufacturer price, and (if applicable) the claimed
9
price, of the related brand of the related item is taken to be reduced
10
by a percentage equal to the percentage by which the agreed price
11
for the new brand was reduced as a result of the application of the
12
subsection mentioned in paragraph (1)(a).
13
(4) Subsection (3) does not apply to the related brand of the related
14
item if:
15
(a) on the reduction day, the approved ex-manufacturer price of
16
the related brand of the related item does not exceed the
17
approved ex-manufacturer price of the related brand of the
18
related item in force on the day before the reduction day,
19
reduced by more than the percentage required under
20
subsection (3); and
21
(b) if there is an applicable claimed price of the related brand of
22
the related item--on the reduction day, the claimed price of
23
the related brand of the related item does not exceed the
24
claimed price of the related brand of the related item in force
25
on the day before the reduction day, reduced by more than
26
the percentage required under subsection (3).
27
Apportioning if pricing quantity changes
28
(5) If the pricing quantity of the related brand of the related item on
29
the day before the reduction day is different from the pricing
30
quantity of the related brand of the related item on the reduction
31
day, then, for the purposes of subsection (3) and paragraph (4)(a),
32
the approved ex-manufacturer price of the related brand of the
33
related item on the day before the reduction day is taken to be the
34
amount worked out using the following formula:
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AEMP1
PQ2
PQ1
ï‚´
1
where:
2
AEMP1
means the amount that was the approved ex-manufacturer
3
price of the related brand of the related item on the day before the
4
reduction day.
5
PQ1
means the pricing quantity of the related brand of the related
6
item on the day before the reduction day.
7
PQ2
means the pricing quantity of the related brand of the related
8
item on the reduction day.
9
Ministerial discretion not to apply, or to reduce, flow-on price
10
reduction
11
(6) In relation to the related brand of the related item, the Minister
12
may, by notifiable instrument, determine that:
13
(a) the approved ex-manufacturer price, and (if applicable) the
14
claimed price, is not to be reduced under subsection (3) in
15
relation to a particular reduction day; or
16
(b) the approved ex-manufacturer price, and (if applicable) the
17
claimed price, is to be reduced by a lower percentage than
18
would otherwise apply under subsection (3) in relation to a
19
particular reduction day.
20
(7) If the Minister makes a determination under paragraph (6)(a),
21
subsection (3) is taken not to have applied to the related brand of
22
the related item.
23
(8) In making a determination under subsection (6):
24
(a) the Minister must take into account what the approved
25
ex-manufacturer price, and (if applicable) the claimed price,
26
of the related brand of the related item would otherwise be
27
under this section in relation to the particular reduction day if
28
a determination were not made; and
29
(b) the Minister may take into account any other matter the
30
Minister thinks is relevant.
31
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Section does not limit Minister's powers
1
(9) This section does not limit the Minister's powers, on or after the
2
reduction day, to make:
3
(a) further price agreements; or
4
(b) determinations under section 85B;
5
for the related brand of the related item.
6
77 Paragraph 99ADH(1)(c)
7
Repeal the paragraph, substitute:
8
(c) the unadjusted price reduction for the brand of the
9
pharmaceutical item is:
10
(i) if section 99ADHC does not apply to the brand of the
11
pharmaceutical item--at least 10%; or
12
(ii) subject to subparagraph (iii), if section 99ADHC applies
13
to the brand of the pharmaceutical item and the
14
approved ex-manufacturer price of the brand of the
15
pharmaceutical item is more than $4--at least 30%; or
16
(iii) if section 99ADHC applies to the brand of the
17
pharmaceutical item, the approved ex-manufacturer
18
price of the brand of the pharmaceutical item is more
19
than $4, and the brand of the pharmaceutical item has
20
passed the 12.5% average unadjusted price reduction
21
test set out in subsection (6) of this section--at least
22
10%.
23
78 Subsection 99ADH(2A)
24
Repeal the subsection.
25
79 At the end of section 99ADH
26
Add:
27
12.5% average unadjusted price reduction test
28
(6) For the purposes of this section, a brand of a pharmaceutical item
29
passes the
12.5% average unadjusted price reduction test
if there
30
have been 3 consecutive data collection periods in respect of which
31
a weighted average disclosed price has been determined for any
32
brand of the pharmaceutical item, where:
33
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(a) the percentage obtained by dividing the total of the
1
unadjusted price reductions for a brand of the pharmaceutical
2
item in respect of each of those data collection periods by 3 is
3
at least 12.5%; and
4
(b) this section did not apply to the brand of the pharmaceutical
5
item in relation to any of those data collection periods; and
6
(c) those data collection periods include the data collection
7
period mentioned in paragraph (1)(a).
8
(7) For the purposes of subsection (6), if the Minister determines the
9
weighted average disclosed price of a brand of a pharmaceutical
10
item in respect of a data collection period for the brand, the
11
unadjusted price reduction for the brand of the pharmaceutical item
12
in respect of the data collection period is the unadjusted price
13
reduction for the brand of the pharmaceutical item when the
14
determination came into force.
15
Note:
See subsection 99ADB(4).
16
80 Subsections 99ADHB(2) to (6)
17
Repeal the subsections, substitute:
18
Price reduction
19
(2) Subject to subsections (6) and (6B), on the reduction day, the
20
approved ex-manufacturer price of the existing brand of the
21
combination item is taken to be reduced in accordance with a
22
method prescribed by the regulations.
23
(3) Different methods may be prescribed by the regulations for
24
different classes of combination items.
25
(4) Subsection (3) does not limit subsection 33(3A) of the
Acts
26
Interpretation Act 1901
.
27
(5) Subject to subsection (6), if the approved ex-manufacturer price of
28
the existing brand of the combination item is reduced under
29
subsection (2), then, on the reduction day, the claimed price (if
30
any) of the existing brand of the combination item is taken to be
31
reduced by a percentage equal to the percentage by which the
32
approved ex-manufacturer price of the existing brand of the
33
combination item is reduced under subsection (2).
34
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Ministerial discretion not to apply, or to reduce, statutory price
1
reduction
2
(6) In relation to the existing brand of the combination item, the
3
Minister may, by notifiable instrument, determine that:
4
(a) the approved ex-manufacturer price, and (if applicable) the
5
claimed price, is not to be reduced under subsection (2) or
6
(5), as the case requires, in relation to a particular reduction
7
day; or
8
(b) the approved ex-manufacturer price, and (if applicable) the
9
claimed price, is to be reduced by a lower percentage than
10
would otherwise apply under subsection (2) or (5), as the
11
case requires, in relation to a particular reduction day.
12
(6A) In making a determination under subsection (6):
13
(a) the Minister must take into account what the approved
14
ex-manufacturer price, and (if applicable) the claimed price,
15
of the existing brand of the combination item would
16
otherwise be under this section in relation to the particular
17
reduction day if a determination were not made; and
18
(b) the Minister may take into account:
19
(i) any advice given to the Minister under
20
subsection 101(4AC) in relation to the combination
21
item; and
22
(ii) any other matter the Minister thinks is relevant.
23
(6B) If the Minister makes a determination under subsection (6), the
24
approved ex-manufacturer price of the existing brand of the
25
combination item is not to be further reduced under this section on
26
any reduction day that occurs after the reduction day specified in
27
the determination made under subsection (6).
28
Section does not limit Minister's powers
29
(6C) This section does not limit the Minister's powers, on or after the
30
reduction day, to make:
31
(a) further price agreements; or
32
(b) determinations under section 85B;
33
for the existing brand of the combination item.
34
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81 Subsections 99ADHB(8) to (12)
1
Repeal the subsections.
2
82 After Division 3B of Part VII
3
Insert:
4
Division 3BA--Floor price of a brand of a pharmaceutical
5
item
6
99ADHC Floor price of a brand of a pharmaceutical item
7
When this section applies
8
(1) Subject to subsection (3), this section applies to a brand (the
9
designated brand
) of a pharmaceutical item if:
10
(a) both:
11
(i) the drug and manner of administration of the
12
pharmaceutical item has been on F2 for at least 42
13
months; and
14
(ii) at the end of the previous data collection period for the
15
designated brand of the pharmaceutical item, at least 30
16
months have passed since the first price reduction under
17
Division 3B of any listed brand of a pharmaceutical
18
item that has the same drug and manner of
19
administration of the pharmaceutical item; or
20
(b) the approved ex-manufacturer price of the designated brand
21
of the pharmaceutical item is $4 or less; or
22
(c) both:
23
(i) the approved ex-manufacturer price of a brand of the
24
pharmaceutical item has been increased on or after
25
1 July 2022 as a result of the making of a price
26
agreement; and
27
(ii) a determination is in force under subsection (2) in
28
relation to the designated brand of the pharmaceutical
29
item; or
30
(d) the approved ex-manufacturer price of the designated brand
31
of the pharmaceutical item has been increased under
32
section 104B.
33
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Note:
Section 104B commences on 1 October 2022.
1
(2) If the approved ex-manufacturer price of a brand of a
2
pharmaceutical item is increased on or after 1 July 2022 as a result
3
of a new agreed price coming into force, the Minister may, by
4
notifiable instrument, determine that paragraph (1)(c) applies to the
5
brand of the pharmaceutical item.
6
(3) This section does not apply to a brand of a pharmaceutical item if:
7
(a) the drug in the pharmaceutical item is included in Schedule 2
8
to the current Poisons Standard (within the meaning of the
9
Therapeutic Goods Act 1989
and as in force from time to
10
time) by reference to a quantity or amount of the drug; and
11
(b) that quantity or amount of the drug is equal to or greater than
12
the total quantity or amount of the drug contained in the
13
quantity or number of units of the brand of the
14
pharmaceutical item in any pack quantity of the brand of the
15
pharmaceutical item.
16
Limits on price reductions
17
(4) The approved ex-manufacturer price of the designated brand of the
18
pharmaceutical item is not to be reduced under this Part unless:
19
(a) the reduction is the result of the making of a price agreement;
20
or
21
(b) the reduction is under section 99ADH as the result of
22
subparagraph 99ADH(1)(c)(ii) or (iii).
23
(5) If, apart from this subsection:
24
(a) the approved ex-manufacturer price of the designated brand
25
of the pharmaceutical item is to be reduced under a provision
26
of this Part; and
27
(b) the reduction would result in the approved ex-manufacturer
28
price being less than $4;
29
then:
30
(c) the approved ex-manufacturer price is not to be reduced
31
under that provision to an amount less than $4; and
32
(d) the approved ex-manufacturer price is instead to be reduced
33
by an amount that would result in the approved
34
ex-manufacturer price being $4; and
35
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(e) the reduction mentioned in paragraph (d) is taken to be a
1
reduction under that provision.
2
When the drug and manner of administration of a pharmaceutical
3
item is taken to have been on F2 for at least 42 months
4
(6) For the purposes of paragraph (1)(a), the drug and manner of
5
administration of a pharmaceutical item is taken to have been on
6
F2 for at least 42 months if:
7
(a) at end of the previous data collection period, the drug in the
8
designated brand of the pharmaceutical item had been on F2
9
for at least 42 months; and
10
(b) on a day at least 42 months before the end of the previous
11
data collection period:
12
(i) there was a related brand of the designated brand of the
13
pharmaceutical item that had the same pharmaceutical
14
item as, or was bioequivalent or biosimilar to, the
15
designated brand of the pharmaceutical item; or
16
(ii) there were 2 or more related brands of the designated
17
brand of the pharmaceutical item that had the same
18
pharmaceutical item as, or were bioequivalent or
19
biosimilar to, each other.
20
(7) For the purposes of this section,
data collection period
has the
21
same meaning as in Division 3B.
22
83 Paragraphs 99AEI(3)(a) and (b)
23
Repeal the paragraphs, substitute:
24
(a) if subsection 99ACB(5) applied to the delisted brand of the
25
existing item--for the purposes of subsection 99ACB(3),
26
subsection 99ACB(5) is taken not to have applied to the
27
delisted brand of the existing item; or
28
(b) if subsection 99ACB(5A) applied to the delisted brand of the
29
existing item--for the purposes of subsection 99ACB(3),
30
subsection 99ACB(5A) is taken not to have applied to the
31
delisted brand of the existing item; or
32
(c) if subsection 99ACD(5) applied to the delisted brand of the
33
existing item--for the purposes of subsection 99ACD(2),
34
subsection 99ACD(5) is taken not to have applied to the
35
delisted brand of the existing item; or
36
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(d) if subsection 99ACD(5A) applied to the delisted brand of the
1
existing item--for the purposes of subsection 99ACD(2),
2
subsection 99ACD(5A) is taken not to have applied to the
3
delisted brand of the existing item.
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1
2022
2
National Health Act 1953
3
84 After Division 3C of Part VII
4
Insert:
5
Division 3CA--Discounts and incentives
6
99AEL Minister's powers if responsible person offers discounts or
7
incentives for certain brands of pharmaceutical items
8
When this section applies
9
(1) This section applies if:
10
(a) a brand of a pharmaceutical item has an approved
11
ex-manufacturer price of $4 or less; and
12
(b) the responsible person offers a discount or incentive, in
13
relation to sales of the brand of the pharmaceutical item, on
14
one or more occasions; and
15
(c) section 99ADHC applies to the brand of the pharmaceutical
16
item.
17
Minister's powers
18
(2) Without limiting any power the Minister may otherwise have under
19
this Part, the Minister may do any or all of the following:
20
(a) by legislative instrument, revoke or vary a determination
21
under subsection 85(6) in relation to the brand of the
22
pharmaceutical item;
23
(b) by legislative instrument, revoke or vary a determination
24
under subsection 85(6) in relation to any brand of any
25
pharmaceutical item of the responsible person;
26
(c) refuse to make a determination under subsection 85(6) in
27
relation to any brand of any pharmaceutical item of the
28
responsible person;
29
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(d) if the only listed brand of a pharmaceutical item would be a
1
brand of the pharmaceutical item of the responsible person--
2
refuse to make:
3
(i) a declaration under subsection 85(2) in relation to the
4
drug in the pharmaceutical item; or
5
(ii) a determination under subsection 85(3) in relation to the
6
form of the pharmaceutical item; or
7
(iii) a determination under subsection 85(5) in relation to the
8
manner of administration of the pharmaceutical item.
9
Note:
For the purposes of paragraphs (b), (c) and (d), a brand mentioned in
10
those paragraphs may be the brand referred to in subsection (1), or a
11
pharmaceutical item mentioned in those paragraphs may be the item
12
referred to in subsection (1).
13
(3) In exercising a power under subsection (2), the Minister must have
14
regard to any relevant information that:
15
(a) relates to discounts or incentives; and
16
(b) was disclosed in compliance with the price disclosure
17
requirements referred to in Division 3B.
18
(4) In exercising a power under subsection (2), the Minister may have
19
regard to the following:
20
(a) the extent to which the discount or incentive will
21
compromise the responsible person's capacity to continue to
22
supply the brand of the pharmaceutical item;
23
(b) whether the responsible person will consistently maintain
24
adequate stock levels of the brand of the pharmaceutical item
25
in the future;
26
(c) the extent to which the discount or incentive will
27
compromise another person's capacity to continue to supply
28
another brand of the pharmaceutical item;
29
(d) any other matter the Minister thinks is relevant.
30
(5) The refusals referred to in paragraphs (2)(c) and (d) are not
31
legislative instruments.
32
Meaning of discount or incentive
33
(6) For the purposes of this section,
discount or
incentive
, in relation
34
to sales of a brand of a pharmaceutical item, means:
35
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(a) anything that results in the net revenue for the brand of the
1
pharmaceutical item for a data collection period for the brand
2
of the pharmaceutical item falling below the amount that
3
would have been the net revenue for the brand of the
4
pharmaceutical item for the data collection period if the price
5
charged for the brand of the pharmaceutical item had been
6
equal to the approved ex-manufacturer price of the brand of
7
the pharmaceutical item; or
8
(b) an incentive given in relation to sales of the brand of the
9
pharmaceutical item.
10
(7) For the purposes of subsection (6),
incentive
and
net revenue
have
11
the same respective meanings as they have when used in
12
regulations made for the purposes of subsection 99ADB(6).
13
(8) For the purposes of subsection (6),
data collection period
has the
14
same meaning as in Division 3B.
15
85 After section 104A
16
Insert:
17
104B Transitional--price increases on 1 October 2022
18
When this section applies
19
(1) Subject to subsections (2) and (3), this section applies to a brand of
20
a pharmaceutical item if, immediately before the start of 1 October
21
2022:
22
(a) the drug in the brand of the pharmaceutical item was on F2;
23
and
24
(b) the brand of the pharmaceutical item had an approved
25
ex-manufacturer price that is less than $3.50.
26
(2) The Minister may, by writing, determine that this section does not
27
apply in relation to all brands of a specified pharmaceutical item.
28
(3) This section does not apply to a brand of a pharmaceutical item if:
29
(a) the drug in the pharmaceutical item is included in Schedule 2
30
to the current Poisons Standard (within the meaning of the
31
Therapeutic Goods Act 1989
and as in force from time to
32
time) by reference to a quantity or amount of the drug; and
33
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(b) that quantity or amount of the drug is equal to or greater than
1
the total quantity or amount of the drug contained in the
2
quantity or number of units of the brand of the
3
pharmaceutical item in any pack quantity of the brand of the
4
pharmaceutical item.
5
Price increases
6
(4) Subject to subsection (7), if, on the day before 1 October 2022, the
7
brand of the pharmaceutical item had an approved ex-manufacturer
8
price of $2 or less, the approved ex-manufacturer price is taken to
9
be increased to $2.50 at the start of 1 October 2022.
10
(5) Subject to subsection (7), if, on the day before 1 October 2022, the
11
brand of the pharmaceutical item had an approved ex-manufacturer
12
price of more than $2 but not more than $3, the approved
13
ex-manufacturer price is taken to be increased by 50 cents at the
14
start of 1 October 2022.
15
(6) Subject to subsection (7), if, on the day before 1 October 2022, the
16
brand of the pharmaceutical item had an approved ex-manufacturer
17
price of more than $3 but less than $3.50, the approved
18
ex-manufacturer price is taken to be increased to $3.50 at the start
19
of 1 October 2022.
20
Apportioning if pricing quantity changes
21
(7) If the pricing quantity of the brand of the pharmaceutical item on
22
the day before 1 October 2022 is more than the pricing quantity of
23
the brand of the pharmaceutical item on 1 October 2022, then the
24
approved ex-manufacturer price of the brand of the pharmaceutical
25
item on 1 October 2022 is taken to be the amount worked out using
26
the following formula:
27
AEMP1
PQ2
PQ1
ï‚´
28
where:
29
AEMP1
means the amount the approved ex-manufacturer price of
30
the brand of the pharmaceutical item would be on 1 October 2022
31
if the pricing quantity had not changed.
32
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PQ1
means the pricing quantity of the brand of the pharmaceutical
1
item on the day before 1 October 2022.
2
PQ2
means the pricing quantity of the brand of the pharmaceutical
3
item on 1 October 2022.
4
Section does not limit Minister's powers
5
(8) This section does not limit the Minister's powers, on or after
6
1 October 2022, to make:
7
(a) price agreements; or
8
(b) determinations under section 85B;
9
in relation to the brand of the pharmaceutical item.
10
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Part 4--Amendments commencing on 1 July 2023
1
National Health Act 1953
2
86 After Division 3C of Part VII
3
Insert:
4
Division 3CAA--Minimum stockholding requirement
5
99AEKA Brands subject to the minimum stockholding requirement
6
For the purposes of this Division, a brand of a pharmaceutical item
7
is subject to the minimum stockholding requirement if
8
section 99ADHC applies to the brand of the pharmaceutical item.
9
99AEKB Minimum stockholding requirement
10
(1) If a brand of a pharmaceutical item is subject to the minimum
11
stockholding requirement, the responsible person for the brand of
12
the pharmaceutical item must keep in stock in Australia at least the
13
applicable quantity of the brand of the pharmaceutical item.
14
(2) For the purposes of this Division, if a quantity of a brand of a
15
pharmaceutical item is not available for sale in Australia by the
16
responsible person, that quantity of the brand of the pharmaceutical
17
item is taken not to be kept in stock.
18
99AEKC Applicable quantity of a brand of a pharmaceutical item
19
(1) For the purposes of this Division, the
applicable quantity
of a
20
brand of a pharmaceutical item is:
21
(a) if the approved ex-manufacturer price of the brand of the
22
pharmaceutical item has not been increased on or after 1 July
23
2022:
24
(i) 4 months stock by reference to usual demand for the
25
brand of the pharmaceutical item; or
26
(ii) if another quantity is ascertained in accordance with a
27
determination under subsection (2)--that quantity; or
28
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(b) if the approved ex-manufacturer price of the brand of the
1
pharmaceutical item was increased on or after 1 July 2022:
2
(i) 6 months stock by reference to usual demand for the
3
brand of the pharmaceutical item; or
4
(ii) if another quantity is ascertained in accordance with a
5
determination under subsection (2)--that quantity.
6
(2) The Minister may, by legislative instrument, make a determination
7
for the purposes of either or both of the following:
8
(a) subparagraph (1)(a)(ii);
9
(b) subparagraph (1)(b)(ii).
10
(3) A quantity ascertained in accordance with a determination under
11
subsection (2) may be a specified number of months stock by
12
reference to usual demand for the brand of the pharmaceutical
13
item.
14
(4) Subsection (3) does not limit subsection (2).
15
(5) For the purposes of this section,
usual demand
for a brand
of a
16
pharmaceutical item is to be ascertained in accordance with the
17
regulations.
18
99AEKD Minister to be notified of breach of minimum stockholding
19
requirements
20
Notification of likely breach of the minimum stockholding
21
requirement
22
(1) If:
23
(a) a brand of a pharmaceutical item is subject to the minimum
24
stockholding requirement; and
25
(b) the responsible person for the brand of the pharmaceutical
26
item forms the belief that the person is likely to breach
27
section 99AEKB in relation to the brand of the
28
pharmaceutical item;
29
the person must:
30
(c) give the Minister a written notice that:
31
(i) informs the Minister of that belief; and
32
(ii) sets out the person's reasons for that belief; and
33
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(d) do so as soon as practicable after forming that belief.
1
Notification of breach of the minimum stockholding requirement
2
(2) If:
3
(a) a brand of a pharmaceutical item is subject to the minimum
4
stockholding requirement; and
5
(b) the responsible person for the brand of the pharmaceutical
6
item has breached section 99AEKB in relation to the brand of
7
the pharmaceutical item;
8
the person must:
9
(c) give the Minister a written notice that:
10
(i) informs the Minister of the breach; and
11
(ii) sets out the person's reasons for the breach; and
12
(d) do so as soon as practicable after the breach.
13
Offence
14
(3) A person commits an offence if:
15
(a) the person is subject to a requirement under subsection (1) or
16
(2); and
17
(b) the person omits to do an act; and
18
(c) the omission breaches the requirement.
19
Penalty: 60 penalty units.
20
(4) Subsection 4K(2) of the
Crimes Act 1914
, which creates daily or
21
continuing offences, does not apply to an offence against
22
subsection (3) of this section.
23
99AEKE Minister's power if responsible person breaches minimum
24
stockholding requirement
25
(1) This section applies if:
26
(a) a brand of a pharmaceutical item is subject to the minimum
27
stockholding requirement; and
28
(b) the responsible person for the brand of the pharmaceutical
29
item has breached section 99AEKB in relation to the brand of
30
the pharmaceutical item.
31
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(2) Without limiting any power the Minister may otherwise have under
1
this Part, the Minister may do any or all of the following:
2
(a) by legislative instrument, revoke or vary a determination
3
under subsection 85(6) in relation to the brand of the
4
pharmaceutical item;
5
(b) by legislative instrument, revoke or vary a determination
6
under subsection 85(6) in relation to any brand of any
7
pharmaceutical item of the responsible person;
8
(c) refuse to make a determination under subsection 85(6) in
9
relation to any brand of any pharmaceutical item of the
10
responsible person;
11
(d) if the only listed brand of a pharmaceutical item would be a
12
brand of the pharmaceutical item of the responsible person--
13
refuse to make:
14
(i) a declaration under subsection 85(2) in relation to the
15
drug in the pharmaceutical item; or
16
(ii) a determination under subsection 85(3) in relation to the
17
form of the pharmaceutical item; or
18
(iii) a determination under subsection 85(5) in relation to the
19
manner of administration of the pharmaceutical item.
20
Note:
For the purposes of paragraphs (b), (c) and (d), a brand mentioned in
21
those paragraphs may be the brand referred to in subsection (1), or a
22
pharmaceutical item mentioned in those paragraphs may be the item
23
referred to in subsection (1).
24
(3) In exercising a power under subsection (2), the Minister must have
25
regard to the following:
26
(a) both:
27
(i) the responsible person's reasons for the breach; and
28
(ii) whether those reasons are, in the Minister's opinion,
29
reasonable;
30
(b) whether, in the Minister's opinion, the responsible person
31
will consistently maintain adequate stock levels of the brand
32
of the pharmaceutical item in the future;
33
(c) whether the responsible person for the brand of the
34
pharmaceutical item has offered discounts or incentives in
35
relation to sales of the brand of the pharmaceutical item;
36
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(d) whether the responsible person for the brand of the
1
pharmaceutical item has previously breached
2
section 99AEKB and, if so:
3
(i) the person's reasons for the breach; and
4
(ii) whether those reasons are, in the Minister's opinion,
5
reasonable;
6
(e) whether the responsible persons for other brands of the
7
pharmaceutical item have breached section 99AEKB in
8
relation to those other brands of the pharmaceutical item;
9
(f) any other matter the Minister thinks is relevant.
10
(4) The refusals referred to in paragraphs (2)(c) and (d) are not
11
legislative instruments.
12
(5) For the purposes of this section,
discount or
incentive
has the same
13
meaning as in section 99AEL.
14
99AEKF Stockholding disclosure requirements
15
(1) The
stockholding disclosure requirements
for a brand of a
16
pharmaceutical item are:
17
(a) to provide information prescribed by the regulations in
18
relation to the quantity of the brand of the pharmaceutical
19
item kept in stock in Australia by the responsible person for
20
the brand of the pharmaceutical item; and
21
(b) to provide that information in the manner and form
22
prescribed by the regulations; and
23
(c) to provide that information at the times prescribed by the
24
regulations.
25
When the stockholding disclosure requirements apply
26
(2) If a brand of a pharmaceutical item is subject to the minimum
27
stockholding requirement, the responsible person for the brand of
28
the pharmaceutical item is required to comply with the
29
stockholding disclosure requirements for the brand of the
30
pharmaceutical item.
31
Schedule 1
Amendments
Part 4
Amendments commencing on 1 July 2023
46
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
Offence for failing to comply with the stockholding disclosure
1
requirements
2
(3) A person commits an offence if:
3
(a) the person is required to comply with the stockholding
4
disclosure requirements for a brand of a pharmaceutical item;
5
and
6
(b) the person fails to comply with those requirements for the
7
brand of the pharmaceutical item.
8
Penalty: 60 penalty units.
9
(4) Subsection 4K(2) of the
Crimes Act 1914
, which creates daily or
10
continuing offences, does not apply to an offence against
11
subsection (3) of this section.
12
87 After paragraph 99AEL(4)(b)
13
Insert:
14
(ba) whether the responsible person has breached
15
section 99AEKB;
16
Amendments
Schedule 1
Amendments commencing on 1 July 2027
Part 5
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
47
Part 5--Amendments commencing on 1 July 2027
1
National Health Act 1953
2
87A Subsection 85AB(4A)
3
Repeal the subsection.
4
88 Subsection 99ACB(1)
5
Omit ", (3), (3A) and (3B)", substitute "and (3)".
6
89 Paragraph 99ACB(2)(c)
7
Omit "applied; or", substitute "applied.".
8
90 Paragraph 99ACB(2)(d)
9
Repeal the paragraph.
10
91 Subsection 99ACB(2A)
11
Repeal the subsection.
12
92 Subparagraph 99ACB(3)(a)(i)
13
Omit "or (5A)".
14
93 Subsection 99ACB(3) (note)
15
Omit "subsections (5) and (5A) of this section are", substitute
16
"subsection (5) of this section is".
17
94 Subsections 99ACB(3A) and (3B)
18
Repeal the subsections.
19
95 Subsections 99ACB(4A) and (4B)
20
Repeal the subsections.
21
96 Subsection 99ACB(5)
22
Omit "25%", substitute "16%".
23
Schedule 1
Amendments
Part 5
Amendments commencing on 1 July 2027
48
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
97 Subsections 99ACB(5A) and (5B)
1
Repeal the subsections.
2
98 Subsection 99ACB(6)
3
Omit "subsections (5) and (5A)", substitute "subsection (5)".
4
99 Paragraph 99ACB(6A)(b)
5
Omit "or (5A)".
6
100 Subsection 99ACB(6B)
7
Omit "subsections (5) and (5A) are", substitute "subsection (5) is".
8
100A Section 99ACBA
9
Repeal the section.
10
101 Subsection 99ACC(2)
11
Omit "(5A),".
12
102 Subsection 99ACC(5)
13
Omit "subsections (5A) and (5C)", substitute "subsection (5C)".
14
103 Subsections 99ACC(5A) and (5B)
15
Repeal the subsections.
16
104 Subsection 99ACD(1)
17
Omit ", (2) and (3)", substitute "and (2)".
18
105 Paragraph 99ACD(1A)(c)
19
Omit "applied; or", substitute "applied.".
20
106 Paragraph 99ACD(1A)(d)
21
Repeal the paragraph.
22
107 Subsection 99ACD(1B)
23
Repeal the subsection.
24
Amendments
Schedule 1
Amendments commencing on 1 July 2027
Part 5
No. , 2021
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
49
108 Subsection 99ACD(2) (note)
1
Omit "subsections (5) and (5A) of this section are", substitute
2
"subsection (5) of this section is".
3
109 Paragraph 99ACD(2A)(a)
4
Omit "or (5A)".
5
110 Subsection 99ACD(3)
6
Repeal the subsection.
7
111 Subsections 99ACD(4A) and (4B)
8
Repeal the subsections.
9
112 Subsection 99ACD(5)
10
Omit "25%", substitute "16%".
11
113 Subsections 99ACD(5A) and (5B)
12
Repeal the subsections.
13
114 Subsection 99ACD(7)
14
Omit "subsections (5) and (5A)", substitute "subsection (5)".
15
115 Paragraph 99ACD(7A)(b)
16
Omit "or (5A)".
17
116 Subsection 99ACD(7B)
18
Omit "subsections (5) and (5A) are", substitute "subsection (5) is".
19
116A Section 99ACEA
20
Repeal the section.
21
117 Subsection 99ACF(1)
22
Omit "(1A),".
23
118 Subsection 99ACF(1) (table item 9)
24
Repeal the item.
25
Schedule 1
Amendments
Part 5
Amendments commencing on 1 July 2027
50
National Health Amendment (Enhancing the Pharmaceutical Benefits
Scheme) Bill 2021
No. , 2021
119 Subsections 99ACF(1A) and (1B)
1
Repeal the subsections.
2
120 Section 99ACP
3
Repeal the section.
4
121 Paragraph 99ACQ(1)(a)
5
Omit "or (5A)" (wherever occurring).
6
122 Paragraph 99ACR(1)(a)
7
Omit "or (5A)" (wherever occurring).
8
123 Paragraph 99AEI(3)(b)
9
Repeal the paragraph.
10
124 Paragraph 99AEI(3)(c)
11
Omit "item; or", substitute "item.".
12
125 Paragraph 99AEI(3)(d)
13
Repeal the paragraph.
14
126 Subsection 101(4AD)
15
Repeal the subsection.
16