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This is a Bill, not an Act. For current law, see the Acts databases.
2016-2017
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
National Health Amendment
(Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
(Health)
A Bill for an Act to amend the National Health Act
1953, and for related purposes
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Price reductions for new brands of
pharmaceutical items
4
Part 1--25% price reduction
4
National Health Act 1953
4
Part 2--16% price reduction
21
National Health Act 1953
21
Schedule 2--Statutory price reductions
30
Part 1--Amendments commencing day after Royal Assent
30
National Health Act 1953
30
Part 2--Amendments commencing 1 July 2022
36
National Health Act 1953
36
Schedule 3--Price disclosure price reduction thresholds
37
Part 1--Amendments commencing day after Royal Assent
37
National Health Act 1953
37
Part 2--Amendments commencing 1 July 2022
41
National Health Act 1953
41
Schedule 4--New brands
42
Part 1--Amendments commencing day after Royal Assent
42
National Health Act 1953
42
Part 2--Amendments commencing 1 July 2022
47
National Health Act 1953
47
Schedule 5--Pharmacy location rules
49
Part 1--Australian Community Pharmacy Authority
49
National Health Act 1953
49
ii
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Part 2--Miscellaneous
50
National Health Act 1953
50
Schedule 6--Name changes
51
National Health Act 1953
51
Schedule 7--Safety net
52
National Health Act 1953
52
Schedule 8--Prescription and supply
58
National Health Act 1953
58
Schedule 9--Data collection
60
National Health Act 1953
60
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
1
A Bill for an Act to amend the National Health Act
1
1953, and for related purposes
2
The Parliament of Australia enacts:
3
1 Short title
4
This Act is the National Health Amendment (Pharmaceutical
5
Benefits--Budget and Other Measures) Act 2017.
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 (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
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
1 October 2018.
1 October 2018
3. Schedule 1,
Part 2
1 July 2022.
1 July 2022
4. Schedule 2,
Part 1
The day after this Act receives the Royal
Assent.
5. Schedule 2,
Part 2
1 July 2022.
1 July 2022
6. Schedule 3,
Part 1
The day after this Act receives the Royal
Assent.
7. Schedule 3,
Part 2
1 July 2022.
1 July 2022
8. Schedule 4,
Part 1
The day after this Act receives the Royal
Assent.
9. Schedule 4,
Part 2
1 July 2022.
1 July 2022
10. Schedules 5
to 9
The day after this Act receives the Royal
Assent.
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
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
3
concerned, and any other item in a Schedule to this Act has effect
1
according to its terms.
2
Schedule 1 Price reductions for new brands of pharmaceutical items
Part 1 25% price reduction
4
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Schedule 1--Price reductions for new brands
1
of pharmaceutical items
2
Part 1--25% price reduction
3
National Health Act 1953
4
1 Subsection 84(1)
5
Repeal the following definitions:
6
(a) definition of subject to a 12.5% price reduction;
7
(b) definition of subject to a 16% price reduction.
8
2 Subsection 84(1)
9
Insert:
10
12.5% price reduction: see subsection 99ACA(2).
11
16% price reduction: see subsection 99ACA(2A).
12
25% price reduction: see subsection 99ACA(2B).
13
3 Section 99AC
14
Omit "16% price reduction" (wherever occurring), substitute "25%
15
price reduction".
16
4 Subsections 99ACA(2) and (2A)
17
Repeal the subsections, substitute:
18
(2) A listed component drug contained in a drug in a combination item
19
has been subject to a 12.5% price reduction if a pharmaceutical
20
item that has:
21
(a) the listed component drug; and
22
(b) the same manner of administration as the combination item;
23
is in a class of pharmaceutical items to which a 12.5%
24
administrative price reduction has applied.
25
Price reductions for new brands of pharmaceutical items Schedule 1
25% price reduction Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
5
(2A) A listed component drug contained in a drug in a combination item
1
has been subject to a 16% price reduction if a pharmaceutical item
2
that has:
3
(a) the listed component drug; and
4
(b) the same manner of administration as the combination item;
5
is in a class of pharmaceutical items to which a 16% administrative
6
price reduction has applied.
7
(2B) A listed component drug contained in a drug in a combination item
8
has been subject to a 25% price reduction if a pharmaceutical item
9
that has:
10
(a) the listed component drug; and
11
(b) the same manner of administration as the combination item;
12
is in a class of pharmaceutical items to which a 25% administrative
13
price reduction has applied.
14
5 Subdivision B of Division 3A of Part VII (heading)
15
Repeal the heading, substitute:
16
Subdivision B--25% price reductions for new brands of
17
pharmaceutical items that are not combination items
18
6 Section 99ACB (heading)
19
Repeal the heading, substitute:
20
99ACB 25% price reduction for new brands of pharmaceutical
21
items that are not combination items
22
7 Paragraphs 99ACB(2)(a), (b) and (c)
23
Omit "or 16%", substitute ", 16% or 25%".
24
8 At the end of subsection 99ACB(2)
25
Add:
26
; or (d) on the day before the determination day:
27
(i) the approved ex-manufacturer price of a listed brand of
28
the existing item on 1 January 2016; or
29
Schedule 1 Price reductions for new brands of pharmaceutical items
Part 1 25% price reduction
6
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
(ii) if subparagraph (i) does not apply--the original
1
approved ex-manufacturer price of the first listed brand
2
of the existing item;
3
has, by virtue of previous price reductions, been reduced by
4
40% or more.
5
9 Subparagraph 99ACB(3)(a)(ii)
6
Omit "item 1 of the table in section 99ACF", substitute
7
"section 99ACH".
8
10 At the end of paragraph 99ACB(3)(a)
9
Add:
10
(iii) subsection 99ACF(2AB) or (2AC);
11
11 Subsection 99ACB(4) (heading)
12
Repeal the heading, substitute:
13
25% price reduction
14
12 Subsection 99ACB(5)
15
Repeal the subsection, substitute:
16
(4A) If, on the day before the determination day:
17
(a) the approved ex-manufacturer price of a listed brand of the
18
existing item on 1 January 2016; or
19
(b) if paragraph (a) does not apply--the original approved
20
ex-manufacturer price of the first listed brand of the existing
21
item;
22
has, by virtue of previous price reductions, been reduced by:
23
(c) 15% or less, subsection (5) applies; and
24
(d) more than 15% but less than 40%, subsection (5A) applies.
25
Note:
If previous price reductions have been 40% or more, see
26
paragraph (2)(d).
27
(5) Subject to subsections (6) and (6A), the agreed price of the new
28
brand of the trigger item that comes into force on the determination
29
day must not exceed the approved ex-manufacturer price, on the
30
day before the determination day, of the existing brand of the
31
existing item, reduced by 25%.
32
Price reductions for new brands of pharmaceutical items Schedule 1
25% price reduction Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
7
(5A) Subject to subsections (6) and (6B), the agreed price of the new
1
brand of the trigger item that comes into force on the determination
2
day must not exceed:
3
(a) 60% of the approved ex-manufacturer price of a listed brand
4
of the existing item on 1 January 2016; or
5
(b) if paragraph (a) does not apply--60% of the original
6
approved ex-manufacturer price of the first listed brand of the
7
existing item.
8
13 Subsection 99ACB(6)
9
Omit "subsection (5)", substitute "subsections (5) and (5A)".
10
14 After subsection 99ACB(6)
11
Insert:
12
Ministerial discretion not to apply, or to reduce, statutory price
13
reduction
14
(6A) For the purposes of subsection (5), the Minister may, by written
15
instrument, determine that the relevant approved ex-manufacturer
16
price mentioned in that subsection is to be worked out using a
17
lower percentage (including zero %) specified in the determination.
18
(6B) For the purposes of paragraphs (5A)(a) and (b), the Minister may,
19
by written instrument, determine that the relevant approved
20
ex-manufacturer price mentioned in those paragraphs is to be
21
worked out using a higher percentage specified in the
22
determination.
23
(6C) In making a determination under subsection (6A) or (6B):
24
(a) the Minister must take into account what the agreed price of
25
the new brand of the trigger item would otherwise be under
26
this section in relation to the particular determination day if a
27
determination were not made; and
28
(b) the Minister may take into account any other matter that the
29
Minister considers relevant.
30
(6D) If the Minister makes a determination under subsection (6A) or
31
(6B), the agreed price of the new brand of the trigger item is not to
32
be further reduced under this section on any determination day that
33
Schedule 1 Price reductions for new brands of pharmaceutical items
Part 1 25% price reduction
8
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
occurs after the determination day specified in the determination
1
made under the relevant subsection.
2
15 At the end of subsection 99ACC(4A)
3
Add:
4
; and (e) to the extent that the single brand of the combination item
5
contains one or more component drugs that are not listed
6
component drugs--must take into account the matters
7
mentioned in paragraph (d) in relation to each component
8
drug that is not a listed component drug (the non-listed
9
component drug) as if:
10
(i) in the case of one non-listed component drug--a
11
declaration under subsection 85(2) was in force in
12
relation to the non-listed component drug on the day the
13
declaration under subsection 85(2) came into force in
14
relation to the listed component drug, or if there is more
15
than one listed component drug, the first listed
16
component drug, of the single brand of the combination
17
item; and
18
(ii) in the case of more than one component drug that is a
19
non-listed component drug--a declaration under
20
subsection 85(2) was in force in relation to each
21
non-listed component drug on the day the declaration
22
under subsection 85(2) came into force in relation to the
23
listed component drug, or if there is more than one
24
listed component drug, the first listed component drug,
25
of the single brand of the combination item.
26
16 Subsection 99ACC(4B)
27
Repeal the subsection, substitute:
28
(4B) If subsection (4) does not apply, then, in agreeing the new price of
29
the single brand of the combination item, the Minister must take
30
into account:
31
(a) in relation to the listed component drug, or each listed
32
component drug, that became subject to statutory price
33
reduction:
34
Price reductions for new brands of pharmaceutical items Schedule 1
25% price reduction Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
9
(i) the approved ex-manufacturer price, on the reduction
1
day, of each brand of a pharmaceutical item that has the
2
drug that is the listed component drug; and
3
(ii) the quantity of the listed component drug contained in
4
the combination item; and
5
(b) to the extent that the single brand of the combination item
6
contains one or more component drugs that are not listed
7
component drugs--the matters mentioned in paragraph (a) in
8
relation to each component drug that is not a listed
9
component drug as if a declaration under subsection 85(2)
10
was in force in relation to each non-listed component drug, as
11
described in paragraph (4A)(e).
12
17 Subsection 99ACC(6)
13
Repeal the subsection, substitute:
14
Subject to statutory price reduction etc.
15
(6) The following provisions have effect:
16
(a) a listed component drug contained in a drug in a combination
17
item becomes subject to statutory price reduction if
18
section 99ACB or 99ADH, or subsection 99ACF(1), (2),
19
(2AB) or (2AC) because of section 99ACH, has applied to a
20
listed brand of a pharmaceutical item that:
21
(i) has the listed component drug; and
22
(ii) has the same manner of administration as the
23
combination item;
24
(b) whichever provision mentioned in paragraph (a) applied, that
25
provision applies to the listed component drug contained in
26
the drug in the combination item in the same way as that
27
provision applies to the listed brand of the pharmaceutical
28
item that:
29
(i) has the listed component drug; and
30
(ii) has the same manner of administration as the
31
combination item;
32
(c) a listed component drug contained in a drug in a combination
33
item becomes subject to statutory price reduction if
34
subsection 99ACF(1) or (2) because of item 2, 3, 4, 5 or 6 in
35
Schedule 1 Price reductions for new brands of pharmaceutical items
Part 1 25% price reduction
10
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
the table in section 99ACF has applied to a listed brand of a
1
pharmaceutical item that has the listed component drug;
2
(d) whichever provision mentioned in paragraph (c) applied, that
3
provision applies to the listed component drug contained in
4
the drug in the combination item in the same way as that
5
provision applies to the listed brand of the pharmaceutical
6
item that has the listed component drug.
7
18 Section 99ACD (heading)
8
Repeal the heading, substitute:
9
99ACD 25% price reduction for new brands of combination items
10
19 Paragraphs 99ACD(1A)(a), (b) and (c)
11
Omit "or 16%", substitute ", 16% or 25%".
12
20 At the end of subsection 99ACD(1A)
13
Add:
14
; or (d) on the day before the determination day:
15
(i) the approved ex-manufacturer price of a listed brand of
16
the existing item on 1 January 2016; or
17
(ii) if subparagraph (i) does not apply--the original
18
approved ex-manufacturer price of the first listed brand
19
of the existing item;
20
has, by virtue of previous price reductions, been reduced by
21
40% or more.
22
21 Subsection 99ACD(4) (heading)
23
Repeal the heading, substitute:
24
25% price reduction
25
22 Subsections 99ACD(5), (6), (6A) and (6B)
26
Repeal the subsections, substitute:
27
(4A) If, on the day before the determination day:
28
(a) the approved ex-manufacturer price of a listed brand of the
29
existing item on 1 January 2016; or
30
Price reductions for new brands of pharmaceutical items Schedule 1
25% price reduction Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
11
(b) if paragraph (a) does not apply--the original approved
1
ex-manufacturer price of the first listed brand of the existing
2
item;
3
has, by virtue of previous price reductions, been reduced by:
4
(c) 15% or less, subsection (5) applies; and
5
(d) more than 15% but less than 40%, subsection (5A) applies.
6
Note:
If previous price reductions have been 40% or more, see
7
paragraph (1A)(d).
8
(5) Subject to subsections (7) and (7A), the agreed price of the new
9
brand of the trigger combination item that comes into force on the
10
determination day must not exceed the approved ex-manufacturer
11
price, on the day before the determination day, of the existing
12
brand of the existing item, reduced by 25%.
13
(5A) Subject to subsections (7) and (7B), the agreed price of the new
14
brand of the trigger combination item that comes into force on the
15
determination day must not exceed:
16
(a) 60% of the approved ex-manufacturer price of a listed brand
17
of the existing item on 1 January 2016; or
18
(b) if paragraph (a) does not apply--60% of the original
19
approved ex-manufacturer price of the first listed brand of the
20
existing item.
21
23 Subsection 99ACD(7)
22
Omit "subsection (5)", substitute "subsections (5) and (5A)".
23
24 After subsection 99ACD(7)
24
Insert:
25
Ministerial discretion not to apply, or to reduce, statutory price
26
reduction
27
(7A) For the purposes of subsection (5), the Minister may, by written
28
instrument, determine that the relevant approved ex-manufacturer
29
price mentioned in that subsection is to be worked out using a
30
lower percentage (including zero %) specified in the determination.
31
(7B) For the purposes of paragraphs (5A)(a) and (b), the Minister may,
32
by written instrument, determine that the relevant approved
33
Schedule 1 Price reductions for new brands of pharmaceutical items
Part 1 25% price reduction
12
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
ex-manufacturer price mentioned in those paragraphs is to be
1
worked out using a higher percentage specified in the
2
determination.
3
(7C) In making a determination under subsection (7A) or (7B):
4
(a) the Minister must take into account what the agreed price of
5
the new brand of the trigger combination item would
6
otherwise be under this section in relation to the particular
7
determination day if a determination were not made; and
8
(b) the Minister may take into account any other matter that the
9
Minister considers relevant.
10
(7D) If the Minister makes a determination under subsection (7A) or
11
(7B), the agreed price of the new brand of the trigger combination
12
item is not to be further reduced under this section on any
13
determination day that occurs after the determination day specified
14
in the determination made under the relevant subsection.
15
25 Section 99ACE (heading)
16
Repeal the heading, substitute:
17
99ACE Flow-on of 25% price reduction to related brands of
18
combination items
19
26 After subsection 99ACE(1)
20
Insert:
21
(1A) If paragraph 99ACD(1A)(d) has applied in relation to a new brand
22
of a new combination item, then this section applies to the related
23
brand of the related item as if:
24
(a) section 99ACD had applied to the new brand of the new
25
combination item; and
26
(b) the current price for the new brand of the new combination
27
item is the new agreed price; and
28
(c) the day that paragraph 99ACD(1A)(d) is satisfied is the same
29
day as the reduction day.
30
Price reductions for new brands of pharmaceutical items Schedule 1
25% price reduction Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
13
Circumstances in which section does not apply
1
(1B) This section does not apply in relation to the related brand of the
2
related item if, on the day before the reduction day:
3
(a) the approved ex-manufacturer price of the related brand of
4
the related item on 1 January 2016; or
5
(b) if paragraph (a) does not apply--the original approved
6
ex-manufacturer price of the first listed related brand of the
7
related item;
8
has, by virtue of previous price reductions, been reduced by 40%
9
or more.
10
27 Subsection 99ACE(2) (heading)
11
Repeal the heading, substitute:
12
25% price reduction
13
28 After subsection 99ACE(2)
14
Insert:
15
(2A) If, on the day before the reduction day:
16
(a) the approved ex-manufacturer price of the related brand of
17
the related item on 1 January 2016; or
18
(b) if paragraph (a) does not apply--the original approved
19
ex-manufacturer price of the related brand of the related item;
20
has, by virtue of previous price reductions, been reduced by:
21
(c) 15% or less, paragraph (3)(a) or (c), or (4)(a) or (c), as the
22
case requires, applies; and
23
(d) more than 15% but less than 40%, paragraph (3)(b) or (d), or
24
(4)(b) or (d), as the case requires, applies.
25
Note:
If previous price reductions have been 40% or more, see
26
subsection (1B).
27
(2B) If, on the day before the reduction day:
28
(a) the claimed price for a particular pack quantity of the related
29
brand of the related item on 1 January 2016; or
30
(b) if paragraph (a) does not apply--the original claimed price
31
for a particular pack quantity of the related brand of the
32
related item;
33
Schedule 1 Price reductions for new brands of pharmaceutical items
Part 1 25% price reduction
14
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
has, by virtue of previous price reductions, been reduced by:
1
(c) 15% or less, paragraph (4A)(a) applies; and
2
(d) more than 15% but less than 40%, paragraph (4A)(b) applies.
3
Note:
If previous price reductions have been 40% or more, see
4
subsection (1B).
5
29 Paragraphs 99ACE(3)(a) and (b)
6
Repeal the paragraphs, substitute:
7
(a) in a price agreement, specify an agreed price for the related
8
brand of the related item that comes into force on the
9
reduction day and, subject to subsections (4B) and (5), does
10
not exceed the approved ex-manufacturer price for the related
11
brand of the related item, on the day before the reduction day,
12
reduced by 25%; or
13
(b) in a price agreement, specify an agreed price for the related
14
brand of the related item that comes into force on the
15
reduction day and, subject to subsections (4B) and (5A), does
16
not exceed:
17
(i) 60% of the approved ex-manufacturer price of the
18
related brand of the related item on 1 January 2016; or
19
(ii) if subparagraph (i) does not apply--60% of the original
20
approved ex-manufacturer price of the related brand of
21
the related item; or
22
(c) in a price determination, specify a determined price for the
23
related brand of the related item that comes into force on the
24
reduction day and, subject to subsections (4B) and (5), does
25
not exceed the approved ex-manufacturer price for the related
26
brand of the related item, on the day before the reduction day,
27
reduced by 25%; or
28
(d) in a price determination, specify a determined price for the
29
related brand of the related item that comes into force on the
30
reduction day and, subject to subsections (4B) and (5A), does
31
not exceed:
32
(i) 60% of the approved ex-manufacturer price of the
33
related brand of the related item on 1 January 2016; or
34
(ii) if subparagraph (i) does not apply--60% of the original
35
approved ex-manufacturer price of the related brand of
36
the related item.
37
Price reductions for new brands of pharmaceutical items Schedule 1
25% price reduction Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
15
30 Paragraphs 99ACE(4)(a) and (b)
1
Repeal the paragraphs, substitute:
2
(a) in a price determination, specify a determined price for the
3
related brand of the related item that comes into force on the
4
reduction day and, subject to subsections (4B) and (5), does
5
not exceed the approved ex-manufacturer price for the related
6
brand of the related item, on the day before the reduction day,
7
reduced by 25%; or
8
(b) in a price determination, specify a determined price for the
9
related brand of the related item that comes into force on the
10
reduction day and, subject to subsections (4B) and (5A), does
11
not exceed:
12
(i) 60% of the approved ex-manufacturer price of the
13
related brand of the related item on 1 January 2016; or
14
(ii) if subparagraph (i) does not apply--60% of the original
15
approved ex-manufacturer price of the related brand of
16
the related item; or
17
(c) in a price agreement, specify an agreed price for the related
18
brand of the related item that comes into force on the
19
reduction day and, subject to subsections (4B) and (5), does
20
not exceed the approved ex-manufacturer price for the related
21
brand of the related item, on the day before the reduction day,
22
reduced by 25%; or
23
(d) in a price agreement, specify an agreed price for the related
24
brand of the related item that comes into force on the
25
reduction day and, subject to subsections (4B) and (5A), does
26
not exceed:
27
(i) 60% of the approved ex-manufacturer price of the
28
related brand of the related item on 1 January 2016; or
29
(ii) if subparagraph (i) does not apply--60% of the original
30
approved ex-manufacturer price of the related brand of
31
the related item.
32
31 Subsection 99ACE(4A)
33
After "of the related brand of the related item that", insert "comes into
34
force on the reduction day and".
35
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32 Paragraphs 99ACE(4A)(a) and (b)
1
Repeal the paragraphs, substitute:
2
(a) subject to subsection (5D), does not exceed the claimed price
3
for that pack quantity of the related brand of the related item,
4
on the day before the reduction day, reduced by 25%; or
5
(b) subject to subsection (5E), does not exceed:
6
(i) 60% of the claimed price for that pack quantity of the
7
related brand of the related item on 1 January 2016; or
8
(ii) if subparagraph (i) does not apply--60% of the original
9
claimed price for that pack quantity of the related brand
10
of the related item.
11
33 Subsection 99ACE(4B)
12
Omit "subparagraphs (3)(a)(ii), (3)(b)(ii), (4)(a)(ii) and (4)(b)(ii)",
13
substitute "paragraphs (3)(a) to (d) and (4)(a) to (d)".
14
34 Subsections 99ACE(5), (5A) and (5B)
15
Repeal the subsections, substitute:
16
Ministerial discretion not to apply, or to reduce, statutory price
17
reduction
18
(5) For the purposes of paragraph (3)(a) or (c) or (4)(a) or (c), the
19
Minister may, by written instrument, determine that the relevant
20
approved ex-manufacturer price mentioned in the relevant
21
paragraph is to be worked out using a lower percentage (including
22
zero %) specified in the determination.
23
(5A) For the purposes of paragraph (3)(b) or (d) or (4)(b) or (d), the
24
Minister may, by written instrument, determine that the relevant
25
approved ex-manufacturer price mentioned in the relevant
26
paragraph is to be worked out using a higher percentage specified
27
in the determination.
28
(5B) In making a determination under subsection (5) or (5A):
29
(a) the Minister must take into account what the approved
30
ex-manufacturer price of the related brand of the related item
31
would otherwise be under this section in relation to the
32
particular reduction day if a determination were not made;
33
and
34
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National Health Amendment (Pharmaceutical Benefits--Budget and
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17
(b) the Minister may take into account any other matter that the
1
Minister considers relevant.
2
(5C) If the Minister makes a determination under subsection (5) or (5A),
3
the agreed price or determined price of the related brand of the
4
related item is not to be further reduced under this section on any
5
reduction day that occurs after the reduction day specified in the
6
relevant determination.
7
(5D) For the purposes of paragraph (4A)(a), the Minister may, by
8
written instrument, determine that the claimed price mentioned in
9
that paragraph is to be worked out using a lower percentage
10
(including zero %) specified in the determination.
11
(5E) For the purposes of paragraph (4A)(b), the Minister may, by
12
written instrument, determine that the claimed price mentioned in
13
that paragraph is to be worked out using a higher percentage
14
specified in the determination.
15
(5F) In making a determination under subsection (5D) or (5E):
16
(a) the Minister must take into account what the claimed price
17
for the pack quantity of the related brand of the related item
18
would otherwise be under this section in relation to the
19
particular reduction day if a determination were not made;
20
and
21
(b) the Minister may take into account any other matter that the
22
Minister considers relevant.
23
(5G) If the Minister makes a determination under subsection (5D) or
24
(5E), the claimed price for the pack quantity of the related brand of
25
the related 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 relevant determination.
28
35 Subsection 99ACF(1) (table item 1)
29
Repeal the item.
30
36 After subsection 99ACF(2)
31
Insert:
32
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Reduction by dollar amounts
1
(2AA) Subject to section 99ACG, if:
2
(a) section 99ACH applies to a listed brand (the related brand)
3
of a pharmaceutical item (the related item) on a day specified
4
in the section (the reduction day); and
5
(b) on the day before the reduction day:
6
(i) the approved ex-manufacturer price of the related brand
7
of the related item on 1 January 2016; or
8
(ii) if subparagraph (i) does not apply--the original
9
approved ex-manufacturer price of the related brand of
10
the related item; or
11
(iii) if applicable, one or more claimed prices of the related
12
brand of the related item on 1 January 2016; or
13
(iv) if subparagraph (iii) does not apply--if applicable, one
14
or more claimed prices, of the related brand of the
15
related item;
16
have, by virtue of previous price reductions, been reduced by:
17
(v) 15% or less, subsection (2AB) applies; and
18
(vi) more than 15% but less than 40%, subsection (2AC)
19
applies.
20
(2AB) Subject to subsections (2A) and (3AA), the approved
21
ex-manufacturer price, or (if applicable) each claimed price, for the
22
related brand of the related item that comes into force on the
23
reduction day must not exceed the approved ex-manufacturer price,
24
or each of the claimed prices, of the related brand of the related
25
item, on the day before the reduction day, reduced by 25%.
26
(2AC) Subject to subsections (2A) and (3AB), the approved
27
ex-manufacturer price, or (if applicable) each claimed price, for the
28
related brand of the related item that comes into force on the
29
reduction day must not exceed:
30
(a) 60% of the approved ex-manufacturer price, or each of the
31
claimed prices, of the related brand of the related item on
32
1 January 2016; or
33
(b) if paragraph (a) does not apply--60% of the original
34
approved ex-manufacturer price, or each of the claimed
35
prices, of the related brand of the related item.
36
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National Health Amendment (Pharmaceutical Benefits--Budget and
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19
37 Subsection 99ACF(2A)
1
Omit "subsection (1) and paragraph (2)(b)", substitute "subsection (1),
2
paragraph (2)(b) and subsections (2AB) and (2AC)".
3
38 After subsection 99ACF(3)
4
Insert:
5
(3AA) For the purposes of subsection (2AB), the Minister may, by written
6
instrument, determine that the relevant approved ex-manufacturer
7
price, or (if applicable) each claimed price, mentioned in that
8
subsection (the specified provision) is to be worked out using a
9
lower percentage (including zero %) specified in the determination.
10
(3AB) For the purposes of paragraphs (2AC)(a) and (b), the Minister may,
11
by written instrument, determine that the relevant approved
12
ex-manufacturer price, or (if applicable) each claimed price,
13
mentioned in those paragraphs (the specified provision) is to be
14
worked out using a higher percentage specified in the
15
determination.
16
39 Subsection 99ACF(3A)
17
Omit "the application of item 2, 3, 4, 5, or 6 of the table in
18
subsection (1)", substitute "the application of an item of the table in
19
subsection (1), or subsection (2AB) or paragraphs (2AC)(a) and (b)".
20
40 At the end of subsection 99ACF(3B)
21
Add ", (3AA) or (3AB)".
22
41 Subparagraph 99ACG(b)(iii)
23
Omit "item 1 of the table in section 99ACF", substitute
24
"section 99ACH".
25
42 At the end of paragraph 99ACG(b)
26
Add:
27
(iv) subsection 99ACF(2AB) or (2AC);
28
43 Section 99ACH (heading)
29
Repeal the heading, substitute:
30
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National Health Amendment (Pharmaceutical Benefits--Budget and
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No. , 2017
99ACH 25% statutory price reduction flow-on to related brands
1
44 Paragraph 99ACH(1)(a)
2
Omit "section 99ACB", substitute "subsection 99ACB(5) or (5A)".
3
45 After subsection 99ACH(1)
4
Insert:
5
(1A) If:
6
(a) paragraph 99ACB(2)(d) applies in relation to a listed brand
7
of the existing item; and
8
(b) on or after the day that paragraph 99ACB(2)(d) applies, a
9
price agreement or a determination under section 85B is in
10
force in relation to any of the listed brands (the related
11
brand) of a pharmaceutical item (the related item) mentioned
12
in subsection (2); and
13
(c) the related item is not a combination item; and
14
(d) the related item is not an exempt item;
15
then this section applies to the related brand of the related item as
16
if:
17
(e) section 99ACB had applied to the brand of the
18
pharmaceutical item; and
19
(f) the current price remains the agreed price for the brand (the
20
new brand) of the pharmaceutical item (the new item); and
21
(g) the agreed price comes into force on the day that
22
paragraph 99ACB(2)(d) is satisfied (the reduction day).
23
46 Subsection 99ACH(2)
24
Omit "paragraph (1)(c)", substitute "paragraphs (1)(c) and (1A)(b)".
25
47 Paragraph 99ACHA(1)(c)
26
Omit "item 1 in the table in section 99ACF", substitute
27
"section 99ACH".
28
Price reductions for new brands of pharmaceutical items Schedule 1
16% price reduction Part 2
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
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21
Part 2--16% price reduction
1
National Health Act 1953
2
48 Section 99AC
3
Omit "25% price reduction" (wherever occurring), substitute "16%
4
price reduction".
5
49 Subsections 99ACA(2), (2A) and (2B)
6
Repeal the subsections, substitute:
7
(2) A listed component drug contained in a drug in a combination item
8
has been subject to a 12.5% price reduction if:
9
(a) any of the following has applied before 1 February 2011 to a
10
brand of a pharmaceutical item that has the listed component
11
drug and has the same manner of administration as the
12
combination item:
13
(i) section 99ACB;
14
(ii) subsection 99ACF(1) or (2) because of item 1 of the
15
table in section 99ACF; or
16
(b) a pharmaceutical item that has the listed component drug and
17
has the same manner of administration as the combination
18
item is in a class of pharmaceutical items to which a 12.5%
19
administrative price reduction has applied.
20
(2A) A listed component drug contained in a drug in a combination item
21
has been subject to a 16% price reduction if:
22
(a) any of the following has applied to a brand of a
23
pharmaceutical item that has the listed component drug and
24
has the same manner of administration as the combination
25
item:
26
(i) section 99ACB;
27
(ii) subsection 99ACF(1) or (2) because of item 1 of the
28
table in section 99ACF; or
29
(b) a pharmaceutical item that has the listed component drug and
30
has the same manner of administration as the combination
31
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Part 2 16% price reduction
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National Health Amendment (Pharmaceutical Benefits--Budget and
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item is in a class of pharmaceutical items to which a 16%
1
administrative price reduction has applied.
2
(2B) A listed component drug contained in a drug in a combination item
3
has been subject to a 25% price reduction if:
4
(a) any of the following has applied on or after 1 October 2018
5
and before 1 July 2022 to a brand of a pharmaceutical item
6
that has the listed component drug and has the same manner
7
of administration as the combination item:
8
(i) section 99ACB;
9
(ii) subsection 99ACF(2AB) or (2AC); or
10
(b) a pharmaceutical item that has the listed component drug and
11
has the same manner of administration as the combination
12
item is in a class of pharmaceutical items to which a 25%
13
administrative price reduction has applied.
14
To avoid doubt, a 25% price reduction occurs even if the reduction
15
is in fact more or less than 25% (including zero %).
16
Note:
Subparagraph (a)(ii)--subsections 99ACF(2AB) and (2AC) were
17
repealed by Part 2 of Schedule 1 to the National Health Amendment
18
(Pharmaceutical Benefits--Budget and Other Measures) Act 2017.
19
50 Subdivision B of Division 3A of Part VII (heading)
20
Repeal the heading, substitute:
21
Subdivision B--16% price reductions for new brands of
22
pharmaceutical items that are not combination items
23
51 Section 99ACB (heading)
24
Repeal the heading, substitute:
25
99ACB 16% price reduction for new brands of pharmaceutical
26
items that are not combination items
27
52 Paragraph 99ACB(2)(c)
28
Omit "applied; or", substitute "applied.".
29
53 Paragraph 99ACB(2)(d)
30
Repeal the paragraph.
31
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National Health Amendment (Pharmaceutical Benefits--Budget and
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23
54 Subparagraph 99ACB(3)(a)(ii)
1
Omit "section 99ACH", substitute "item 1 of the table in
2
section 99ACF".
3
55 Subparagraph 99ACB(3)(a)(iii)
4
Repeal the subparagraph.
5
56 Subsection 99ACB(4) (heading)
6
Repeal the heading, substitute:
7
16% price reduction
8
57 Subsections 99ACB(4A), (5) and (5A)
9
Repeal the subsections, substitute:
10
(5) Subject to subsection (6), the agreed price for the new brand of the
11
trigger item that comes into force on the determination day must
12
not exceed the approved ex-manufacturer price, on the day before
13
the determination day, of the existing brand of the existing item,
14
reduced by 16%.
15
58 Subsection 99ACB(6)
16
Omit "subsections (5) and (5A)", substitute "subsection (5)".
17
59 Subsections 99ACB(6A) to (6D)
18
Repeal the subsections.
19
60 Paragraph 99ACC(6)(a)
20
Omit "subsection 99ACF(1), (2), (2AB) or (2AC) because of
21
section 99ACH", substitute "subsection 99ACF(1) or (2) because of
22
item 1 of the table in section 99ACF".
23
61 Section 99ACD (heading)
24
Repeal the heading, substitute:
25
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99ACD 16% price reduction for new brands of combination items
1
62 Paragraph 99ACD(1A)(c)
2
Omit "applied; or", substitute "applied.".
3
63 Paragraph 99ACD(1A)(d)
4
Repeal the paragraph.
5
64 Subsection 99ACD(4) (heading)
6
Repeal the heading, substitute:
7
16% price reduction
8
65 Subsections 99ACD(4A), (5) and (5A)
9
Repeal the subsections, substitute:
10
(5) Subject to subsections (6) to (7), the agreed price of the new brand
11
of the trigger combination item must not exceed the approved
12
ex-manufacturer price, on the day before the determination day, of
13
the existing brand of the existing item, reduced by 16%.
14
Adjustment for prior price reductions to component drugs
15
(6) If, on a day before the determination day:
16
(a) one or more of the listed component drugs (the component)
17
contained in the drug in the existing item had been subject to
18
one of the following (the prior price reduction of the
19
component):
20
(i) a 12.5% price reduction;
21
(ii) a 16% price reduction;
22
(iii) a 25% price reduction; and
23
(b) because of the prior price reduction of the component, the
24
approved ex-manufacturer price of the existing brand of the
25
existing item was, or if subparagraph (a)(iii) applies, was or
26
would have been, reduced;
27
then the reduction referred to in subsection (5) is to be adjusted to
28
reflect:
29
(c) the percentage (the flowed-on percentage) of the prior price
30
reduction of the component that was taken into account in
31
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National Health Amendment (Pharmaceutical Benefits--Budget and
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25
working out the amount of the reduction to the approved
1
ex-manufacturer price of the existing brand of the existing
2
item; and
3
(d) the quantity of the component contained in the drug in the
4
existing item.
5
(6A) For the purposes of subsection (6), if:
6
(a) the prior price reduction of the component was a 12.5% price
7
reduction; and
8
(b) the flowed-on percentage was 100%;
9
then the reduction referred to in subsection (5) is to be adjusted so
10
that there is no further reduction in relation to the component.
11
(6B) For the purposes of subsection (6), if:
12
(a) the prior price reduction of the component was a 12.5% price
13
reduction; and
14
(b) the flowed-on percentage was less than 100%;
15
then the reduction referred to in subsection (5) is to be adjusted so
16
that the percentage worked out as follows is taken into account in
17
relation to the component:
18


12.5%
Flowed-on percentage
12.5%
ï€-
ï‚´
19
66 Subsection 99ACD(7)
20
Omit "subsections (5) and (5A)", substitute "subsection (5)".
21
67 Subsections 99ACD(7A) to (7D)
22
Repeal the subsections.
23
68 Section 99ACE (heading)
24
Repeal the heading, substitute:
25
99ACE Flow-on of 16% price reduction to related brands of
26
combination items
27
69 Subsections 99ACE(1A) and (1B)
28
Repeal the subsections.
29
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Part 2 16% price reduction
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No. , 2017
70 Subsection 99ACE(2) (heading)
1
Repeal the heading, substitute:
2
16% price reduction
3
71 Subsections 99ACE(2A) and (2B)
4
Repeal the subsections.
5
72 Paragraphs 99ACE(3)(a) to (d)
6
Repeal the paragraphs, substitute:
7
(a) in a price agreement, specify an agreed price for the related
8
brand of the related item that:
9
(i) comes into force on the reduction day; and
10
(ii) subject to subsections (4B) and (5) to (5B), does not
11
exceed the approved ex-manufacturer price in force, on
12
the day before that day, for the related brand of the
13
related item, reduced by 16%; or
14
(b) in a price determination, specify a determined price for the
15
related brand of the related item that:
16
(i) comes into force on the reduction day; and
17
(ii) subject to subsections (4B) and (5) to (5B), does not
18
exceed the approved ex-manufacturer price in force, on
19
the day before that day, for the related brand of the
20
related item, reduced by 16%.
21
73 Paragraphs 99ACE(4)(a) to (d)
22
Repeal the paragraphs, substitute:
23
(a) in a price determination, specify a determined price for the
24
related brand of the related item that:
25
(i) comes into force on the reduction day; and
26
(ii) subject to subsections (4B) and (5) to (5B), does not
27
exceed the approved ex-manufacturer price in force, on
28
the day before that day, for the related brand of the
29
related item, reduced by 16%; or
30
(b) in a price agreement, specify an agreed price for the related
31
brand of the related item that:
32
(i) comes into force on the reduction day; and
33
Price reductions for new brands of pharmaceutical items Schedule 1
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National Health Amendment (Pharmaceutical Benefits--Budget and
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27
(ii) subject to subsections (4B) and (5) to (5B), does not
1
exceed the approved ex-manufacturer price in force, on
2
the day before that day, for the related brand of the
3
related item, reduced by 16%.
4
74 Subsection 99ACE(4A)
5
Repeal the subsection, substitute:
6
(4A) If a determination under subsection 85B(3) was in force for a
7
particular pack quantity of the related brand of the related item on
8
the day before the reduction day, the Minister may, in a
9
determination under subsection 85B(3), specify a claimed price for
10
that pack quantity of the related brand of the related item that:
11
(a) comes into force on the reduction day; and
12
(b) subject to subsections (5) to (5B), does not exceed the
13
claimed price in force for that pack quantity of the related
14
brand of the related item on the day before that day, reduced
15
by 16%.
16
75 Subsection 99ACE(4B)
17
Omit "paragraphs (3)(a) to (d) and (4)(a) to (d)", substitute
18
"subparagraphs (3)(a)(ii), (3)(b)(ii), (4)(a)(ii) and (4)(b)(ii)".
19
76 Subsections 99ACE(5) to (5G)
20
Repeal the subsections, substitute:
21
Adjustment for prior price reductions to component drugs
22
(5) If, on a day before the reduction day:
23
(a) one or more of the listed component drugs (the component)
24
contained in the related item had been subject to one of the
25
following (the prior price reduction of the component):
26
(i) a 12.5% price reduction;
27
(ii) a 16% price reduction;
28
(iii) a 25% price reduction; and
29
(b) because of the prior price reduction of the component, the
30
approved ex-manufacturer price of the related brand of the
31
related item was, or if subparagraph (a)(iii) applies, was or
32
would have been, reduced;
33
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Part 2 16% price reduction
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National Health Amendment (Pharmaceutical Benefits--Budget and
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No. , 2017
then the reduction referred to in subsection (3), (4) or (4A) is to be
1
adjusted to reflect:
2
(c) the percentage (the flowed-on percentage) of the prior price
3
reduction of the component that was taken into account in
4
working out the amount of the reduction to the approved
5
ex-manufacturer price of the related brand of the related item;
6
and
7
(d) the quantity of the component contained in the drug in the
8
related item.
9
(5A) For the purposes of subsection (5), if:
10
(a) the prior price reduction of the component was a 12.5% price
11
reduction; and
12
(b) the flowed-on percentage was 100%;
13
then the reduction referred to in subsection (3), (4) or (4A) is to be
14
adjusted so that there is no further reduction in relation to the
15
component.
16
(5B) For the purposes of subsection (5), if:
17
(a) the prior price reduction of the component was a 12.5% price
18
reduction; and
19
(b) the flowed-on percentage was less than 100%;
20
then the reduction referred to in subsection (3), (4) or (4A) is to be
21
adjusted so that the percentage worked out as follows is taken into
22
account in relation to the component:
23


12.5%
Flowed-on percentage
12.5%
ï€-
ï‚´
24
25
77 Subsection 99ACF(1) (before table item 2)
26
Insert:
27
1
99ACH
16%
78 Subsections 99ACF(2AA), (2AB) and (2AC)
28
Repeal the subsections.
29
79 Subsection 99ACF(2A)
30
Omit "subsection (1), paragraph (2)(b) and subsections (2AB) and
31
(2AC)", substitute "subsection (1) and paragraph (2)(b)".
32
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16% price reduction Part 2
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
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29
80 Subsections 99ACF(3AA) and (3AB)
1
Repeal the subsections.
2
81 Subparagraph 99ACG(b)(iii)
3
Omit "section 99ACH", substitute "item 1 of the table in
4
section 99ACF".
5
82 Subparagraph 99ACG(b)(iv)
6
Repeal the subparagraph.
7
83 Section 99ACH (heading)
8
Repeal the heading, substitute:
9
99ACH 16% statutory price reduction flow-on to related brands
10
84 Paragraph 99ACH(1)(a)
11
Omit "subsection 99ACB(5) or (5A)", substitute "section 99ACB".
12
85 Subsection 99ACH(1A)
13
Repeal the subsection.
14
86 Subsection 99ACH(2)
15
Omit "paragraphs (1)(c) and (1A)(b)", substitute "paragraph (1)(c)".
16
87 Paragraph 99ACHA(1)(c)
17
Omit "section 99ACH", substitute "item 1 in the table in
18
section 99ACF".
19
Schedule 2 Statutory price reductions
Part 1 Amendments commencing day after Royal Assent
30
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Schedule 2--Statutory price reductions
1
Part 1--Amendments commencing day after Royal
2
Assent
3
National Health Act 1953
4
1 Section 99AC
5
Omit:
6
(b) arise if a pharmaceutical item has had a drug on F1 for 5 years
7
on a particular day.
8
substitute:
9
(b) occur on a particular day if, on that day, the pharmaceutical
10
item has a drug on F1 and that drug has been a listed drug for
11
at least 5 years, 10 years or 15 years.
12
Price reductions for listed brands of pharmaceutical items under
13
this Division are subject to:
14
(a) determinations made by the Minister to not apply, or reduce,
15
the price reduction; or
16
(b) price reductions made under Subdivision E of Division 3B
17
(see section 99ACG).
18
2 Subsection 99ACF(1) (heading)
19
Repeal the heading, substitute:
20
Reduction equal to percentage etc.
21
3 Paragraph 99ACF(1)(a)
22
After "section" (wherever occurring), insert "or subsection".
23
Statutory price reductions Schedule 2
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No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
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31
4 Subsection 99ACF(1)
1
Omit "subsection (2A)", substitute "subsections (2A) and (3)".
2
5 Subsection 99ACF(1)
3
Omit "by the percentage specified in column 3 of the table for the
4
section", substitute "by the percentage or method specified in column 3
5
of the table for the section or subsection".
6
6 Subsection 99ACF(1) (table, heading to column headed
7
"Section")
8
Repeal the heading, substitute:
9
Section or subsection
10
7 Subsection 99ACF(1) (table, heading to column headed
11
"Percentage")
12
Repeal the heading, substitute:
13
Percentage or method
14
8 Subsection 99ACF(1) (at the end of the table)
15
Add:
16
17
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 99ACF(2)(a)
18
After "section", insert "or subsection".
19
10 Paragraphs 99ACF(2)(b) and (c)
20
Omit "the percentage specified in column 3 of the table for the section",
21
substitute "the percentage or method specified in column 3 of the table
22
for the section or subsection".
23
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Part 1 Amendments commencing day after Royal Assent
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National Health Amendment (Pharmaceutical Benefits--Budget and
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No. , 2017
11 Before subsection 99ACF(4)
1
Insert:
2
Ministerial discretion not to apply, or to reduce, statutory price
3
reduction
4
(3) In relation to a listed brand of a pharmaceutical item, the Minister
5
may, by written instrument, determine that:
6
(a) the approved ex-manufacturer price is, or (if applicable) one
7
or more claimed prices are, not to be reduced under a
8
provision mentioned in items 2 to 6 of the table in
9
subsection (1) (the specified provision) in relation to a
10
particular reduction day; or
11
(b) the approved ex-manufacturer price is, or (if applicable) one
12
or more of the claimed prices are, to be reduced by a lower
13
percentage than would otherwise apply under a provision
14
mentioned in items 2 to 6 of the table in subsection (1) (the
15
specified provision) in relation to a particular reduction day.
16
(3A) In making a determination in relation to the application of item 2,
17
3, 4, 5, or 6 of the table in subsection (1):
18
(a) the Minister must take into account what the approved
19
ex-manufacturer price, and (if applicable) each of the claimed
20
prices, of the listed brand of the pharmaceutical item would
21
otherwise be under this section in relation to the particular
22
reduction day if a determination were not made; and
23
(b) the Minister may take into account any other matter that the
24
Minister considers relevant.
25
(3B) If the Minister makes a determination in relation to a specified
26
provision, the approved ex-manufacturer price is, and (if
27
applicable) each of the claimed prices are, not to be further reduced
28
under that specified provision on any reduction day that occurs
29
after the reduction day specified in the determination made under
30
subsection (3).
31
12 Subsection 99ACF(4)
32
Omit "after the reduction day", substitute "on or after the reduction
33
day".
34
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National Health Amendment (Pharmaceutical Benefits--Budget and
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33
13 Paragraph 99ACG(b)
1
Omit "this subsection", substitute "this section".
2
14 Section 99ACHA (heading)
3
Repeal the heading, substitute:
4
99ACHA 5% statutory price reduction for drugs on F1--fifth
5
anniversary
6
15 Paragraph 99ACHA(1)(b)
7
Repeal the paragraph, substitute:
8
(b) the 5% price reduction day is on or after the fifth anniversary
9
of the drug being a listed drug; and
10
16 Paragraph 99ACHA(1)(c)
11
Omit "this Subdivision", substitute "subsection 99ACF(1) or (2)
12
because of item 1 in the table in section 99ACF".
13
17 At the end of subsection 99ACHA(2)
14
Add:
15
; (f) 1 April 2021;
16
(g) 1 April 2022.
17
18 At the end of Division 3A of Part VII
18
Add:
19
99ACJ 10% statutory price reduction for drugs on F1--tenth
20
anniversary
21
(1) This section applies to a brand of a pharmaceutical item on a 10%
22
price reduction day if:
23
(a) the drug in the pharmaceutical item is on F1 on the 10% price
24
reduction day; and
25
(b) the 10% price reduction day is on or after the tenth
26
anniversary of the drug being a listed drug; and
27
(c) the approved ex-manufacturer price of a brand of a
28
pharmaceutical item that has the drug, on the day before the
29
Schedule 2 Statutory price reductions
Part 1 Amendments commencing day after Royal Assent
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National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
10% price reduction day, has not been reduced under
1
subsection 99ACF(1) or (2) because of:
2
(i) item 3 in the table in section 99ACF on a previous 10%
3
price reduction day; or
4
(ii) item 5 in the table in section 99ACF on 1 June 2018.
5
(2) In this section, each of the following is a 10% price reduction day:
6
(a) 1 April 2019;
7
(b) 1 April 2020;
8
(c) 1 April 2021.
9
99ACK 5% statutory price reduction for drugs on F1--15th
10
anniversary
11
(1) This section applies to a brand of a pharmaceutical item on a 5%
12
price reduction day if:
13
(a) the drug in the pharmaceutical item is on F1 on the 5% price
14
reduction day; and
15
(b) the 5% price reduction day is on or after the 15th anniversary
16
of the drug being a listed drug; and
17
(c) the approved ex-manufacturer price of a brand of a
18
pharmaceutical item that has the drug, on the day before the
19
5% price reduction day, has not been reduced under
20
subsection 99ACF(1) or (2) because of:
21
(i) item 4 in the table in section 99ACF on a previous 5%
22
price reduction day; or
23
(ii) item 6 in the table in section 99ACF on 1 June 2018.
24
(2) In this section, each of the following is a 5% price reduction day:
25
(a) 1 April 2019;
26
(b) 1 April 2020;
27
(c) 1 April 2021.
28
99ACL Special rule--statutory price reduction for drugs on F1
29
Tenth anniversary of listing of drug falls on or before 1 June 2018
30
(1) This subsection applies to a brand of a pharmaceutical item if:
31
Statutory price reductions Schedule 2
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National Health Amendment (Pharmaceutical Benefits--Budget and
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35
(a) the drug in the pharmaceutical item is on F1 on 1 June 2018
1
(the price reduction day); and
2
(b) the price reduction day is on or after the tenth anniversary of
3
the drug being a listed drug; and
4
(c) subsection (2) is not satisfied in relation to the brand of the
5
pharmaceutical item.
6
15th anniversary of listing of drug falls on or before 1 June 2018
7
(2) This subsection applies to a brand of a pharmaceutical item if:
8
(a) the drug in the pharmaceutical item is on F1 on 1 June 2018
9
(the price reduction day); and
10
(b) the price reduction day is on or after the 15th anniversary of
11
the drug being a listed drug.
12
Schedule 2 Statutory price reductions
Part 2 Amendments commencing 1 July 2022
36
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Part 2--Amendments commencing 1 July 2022
1
National Health Act 1953
2
19 Section 99AC
3
Omit:
4
Price reductions for listed brands of pharmaceutical items under
5
this Division are subject to:
6
(a) determinations made by the Minister to not apply, or reduce,
7
the price reduction; or
8
(b) price reductions made under Subdivision E of Division 3B
9
(see section 99ACG).
10
substitute:
11
Price reductions for listed brands of pharmaceutical items under
12
this Division are subject to price reductions made under
13
Subdivision E of Division 3B (see section 99ACG).
14
20 Subsections 99ACF(3) to (3B)
15
Repeal the subsections.
16
Price disclosure price reduction thresholds Schedule 3
Amendments commencing day after Royal Assent Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
37
Schedule 3--Price disclosure price reduction
1
thresholds
2
Part 1--Amendments commencing day after Royal
3
Assent
4
National Health Act 1953
5
1 Subsection 99ADB(1)
6
Insert:
7
data collection period, for a brand of a pharmaceutical item, has
8
the meaning given by section 99ADBA.
9
related brand, of a brand of a pharmaceutical item, means a brand
10
of a pharmaceutical item that has the same drug and manner of
11
administration as the first-mentioned pharmaceutical item
12
(including another brand of the same pharmaceutical item), but
13
does not include a brand of an exempt item.
14
start day, for a brand of a pharmaceutical item, means the day that
15
the brand was first required to comply with the price disclosure
16
requirements under section 99ADD.
17
2 At the end of Subdivision A of Division 3B of Part VII
18
Add:
19
99ADBA Meaning of data collection period
20
Start of first data collection period
21
(1) The first data collection period for a brand of a pharmaceutical
22
item starts on the brand's start day.
23
End of first data collection period
24
(2) If, on the day before the brand's start day (the starting brand) the
25
price disclosure requirements apply to a related brand of the
26
Schedule 3 Price disclosure price reduction thresholds
Part 1 Amendments commencing day after Royal Assent
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National Health Amendment (Pharmaceutical Benefits--Budget and
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No. , 2017
starting brand, the starting brand's first data collection period ends
1
when the data collection period for any of the related brands ends.
2
(3) Otherwise, the starting brand's first data collection period ends on:
3
(a) if the start day occurs between 2 April and 1 October--the
4
next 31 March; or
5
(b) if the start day occurs between 2 October and 1 April--the
6
next 30 September.
7
Start and end of subsequent data collection periods
8
(4) After the first data collection period for a listed brand of a
9
pharmaceutical item, each subsequent data collection period for the
10
brand:
11
(a) starts immediately after the end of the previous data
12
collection period; and
13
(b) ends on the next 31 March or 30 September, whichever is
14
sooner.
15
Example 1: If a brand to which subsection (2) applies has a start day of 1 July
16
2016, and the data collection period for a related brand ends on
17
30 September 2016:
18
(a) the first data collection period starts on 1 July 2016; and
19
(b) the first data collection period ends on 30 September 2016; and
20
(c) subsequent data collection periods will be the 6 month periods
21
that start on 1 October 2016, 1 April 2017, 1 October 2017 and
22
so on.
23
Example 2: If a brand to which subsection (3) applies has a start day of 1 August
24
2016:
25
(a) the first data collection period starts on 1 August 2016; and
26
(b) the first data collection period ends on 31 March 2017; and
27
(c) subsequent data collection periods will be the 6 month periods
28
that start on 1 April 2017, 1 October 2017, 1 April 2018 and so
29
on.
30
Example 3: If a brand to which subsection (3) applies has a start day of
31
1 December 2016:
32
(a) the first data collection period starts on 1 December 2016; and
33
(b) the first data collection period ends on 30 September 2017; and
34
(c) subsequent data collection periods will be the 6 month periods
35
that start on 1 October 2017, 1 April 2018, 1 October 2018 and
36
so on.
37
Price disclosure price reduction thresholds Schedule 3
Amendments commencing day after Royal Assent Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
39
3 Paragraph 99ADH(1)(a)
1
After "pharmaceutical item", insert "(the WADP brand) in respect of a
2
data collection period for the brand".
3
4 Paragraph 99ADH(1)(c)
4
Repeal the paragraph, substitute:
5
(c) the unadjusted price reduction for the brand of the
6
pharmaceutical item is:
7
(i) if the drug and manner of administration of the
8
pharmaceutical item has been on F2 for less than 42
9
months--at least 10%; and
10
(ii) subject to subparagraph (iii), if the drug and manner of
11
administration of the pharmaceutical item has been on
12
F2 for at least 42 months--at least 30%; and
13
(iii) if the drug and manner of administration of the
14
pharmaceutical item has been on F2 for at least 42
15
months and has had 2 consecutive price reductions
16
under subparagraph (ii) in relation to the brand of the
17
pharmaceutical item--at least 10%.
18
5 After subsection 99ADH(2)
19
Insert:
20
(2A) For the purposes of paragraph (1)(c), the drug and manner of
21
administration of a pharmaceutical item is taken to have been on
22
F2 for at least 42 months if:
23
(a) at end of the previous data collection period, the drug in the
24
WADP brand had been on F2 for at least 42 months; and
25
(b) on a day at least 42 months before the end of the previous
26
data collection period:
27
(i) there was a related brand of the WADP brand that had
28
the same pharmaceutical item as, or was bioequivalent
29
or biosimilar to, the WADP brand; or
30
(ii) there were 2 or more related brands of the WADP brand
31
that had the same pharmaceutical item as, or were
32
bioequivalent or biosimilar to, each other.
33
Schedule 3 Price disclosure price reduction thresholds
Part 1 Amendments commencing day after Royal Assent
40
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
6 Subsection 99ADH(5)
1
Omit "after the reduction day", substitute "on or after the reduction
2
day".
3
7 Application
4
The amendments made by this Part apply to a determination of a day
5
(the reduction day) by the Minister, by legislative instrument, for the
6
purposes of section 99ADH of the National Health Act 1953 if the
7
reduction day occurs on or after the day this item commences.
8
Price disclosure price reduction thresholds Schedule 3
Amendments commencing 1 July 2022 Part 2
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
41
Part 2--Amendments commencing 1 July 2022
1
National Health Act 1953
2
8 Subsection 99ADB(1)
3
Repeal the following definitions:
4
(a) definition of data collection period;
5
(b) definition of related brand;
6
(c) definition of start day.
7
9 Section 99ADBA
8
Repeal the section.
9
10 Paragraph 99ADH(1)(a)
10
Omit "(the WADP brand) in respect of a data collection period for the
11
brand".
12
11 Paragraph 99ADH(1)(c)
13
Repeal the paragraph, substitute:
14
(c) the unadjusted price reduction for the brand of the
15
pharmaceutical item is at least 10%.
16
12 Subsection 99ADH(2A)
17
Repeal the subsection.
18
Schedule 4 New brands
Part 1 Amendments commencing day after Royal Assent
42
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Schedule 4--New brands
1
Part 1--Amendments commencing day after Royal
2
Assent
3
National Health Act 1953
4
1 After subsection 85AB(4)
5
Insert:
6
(4A) For the purposes of working out whether paragraph (4)(a) or (b) is
7
satisfied, a brand of a pharmaceutical item that has the drug is to be
8
disregarded if:
9
(a) both:
10
(i) subsection 99ACB(3A) or (3B) applies to the brand of
11
the pharmaceutical item that has the drug; and
12
(ii) there is not another brand of the pharmaceutical item
13
that has the drug that is a listed brand; or
14
(b) both:
15
(i) subsection 99ACB(3A) or (3B) applies to the brand of
16
the pharmaceutical item that has the drug; and
17
(ii) the drug is not on F2; or
18
(c) both:
19
(i) subsection 99ACB(3B) applies to the brand of the
20
pharmaceutical item that has the drug; and
21
(ii) the tenth anniversary of the drug in the pharmaceutical
22
item being on F1 has not occurred.
23
2 Subsection 99ACB(1)
24
Omit "and (3)", substitute ", (3), (3A) and (3B)".
25
3 After subsection 99ACB(3)
26
Insert:
27
(3A) This section does not apply in relation to the new brand of the
28
trigger item if:
29
New brands Schedule 4
Amendments commencing day after Royal Assent Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
43
(a) the new brand of the trigger item is a new presentation of an
1
existing listed brand of a pharmaceutical item; and
2
(b) the determination day in relation to the new brand of the
3
trigger item is on or before the fifth anniversary of the drug
4
in the pharmaceutical item being on F1; and
5
(c) the responsible person for the new brand of the trigger item is
6
the same person as the responsible person for the existing
7
listed brand of the pharmaceutical item; and
8
(d) either of the following apply:
9
(i) there is not another brand of the pharmaceutical item
10
that has the drug that is a listed brand;
11
(ii) the drug is not on F2.
12
(3B) This section does not apply in relation to the new brand of the
13
trigger item if:
14
(a) the new brand of the trigger item is a new presentation of an
15
existing listed brand of a pharmaceutical item; and
16
(b) the Minister has made a determination under
17
section 99ACBA in relation to the new brand of the trigger
18
item; and
19
(c) the determination under section 99ACBA has not ceased to
20
have effect.
21
4 At the end of Subdivision B of Division 3A of Part VII
22
Add:
23
99ACBA Ministerial determination--brand of pharmaceutical item
24
that is not a combination item is not a new brand
25
(1) If:
26
(a) a brand of a pharmaceutical item (the trigger item) is not a
27
combination item; and
28
(b) the brand of the trigger item:
29
(i) is not a listed brand of the trigger item; and
30
(ii) is a new presentation of an existing listed brand of a
31
pharmaceutical item; and
32
(c) the Minister is satisfied that the determination day in relation
33
to the brand of the trigger item is to be after the fifth
34
Schedule 4 New brands
Part 1 Amendments commencing day after Royal Assent
44
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
anniversary, and before the tenth anniversary, of the drug in
1
the pharmaceutical item being on F1;
2
the Minister may determine, by notifiable instrument, that the
3
brand of the trigger item is not a new brand for the purposes of
4
section 99ACB.
5
(2) If the Minister makes a determination under this section in relation
6
to the brand of the trigger item, it must be made before the
7
determination day in relation to the brand of the trigger item.
8
(3) In making a determination, the Minister may have regard to:
9
(a) any advice given by the Pharmaceutical Benefits Advisory
10
Committee; and
11
(b) any information provided by the responsible person for the
12
brand of the trigger item; and
13
(c) any other matter that the Minister considers relevant.
14
(4) A determination made under this section ceases to have effect on
15
whichever is the earliest of the following:
16
(a) the day that another brand of the pharmaceutical item
17
becomes a listed brand;
18
(b) the day that the drug in the pharmaceutical item does not
19
satisfy all of the criteria for F1;
20
(c) the tenth anniversary of the drug in the pharmaceutical item
21
being on F1.
22
(5) In this section:
23
determination day has the same meaning as in
24
paragraph 99ACB(1)(a).
25
5 Subsection 99ACD(1)
26
Omit "and (2)", substitute ", (2) and (3)".
27
6 After subsection 99ACD(2)
28
Insert:
29
(3) This section does not apply in relation to the new brand of the
30
trigger combination item if:
31
(a) all of the following apply:
32
New brands Schedule 4
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No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
45
(i) the new brand of the trigger combination item is a new
1
presentation of an existing listed brand of a
2
pharmaceutical item;
3
(ii) a declaration under subsection 85(2) is in force in
4
relation to the drug in the pharmaceutical item;
5
(iii) the determination day in relation to the new brand of the
6
trigger combination item is on or before the fifth
7
anniversary of the declaration under subsection 85(2)
8
being made;
9
(iv) the responsible person for the new brand of the trigger
10
combination item is the same as the responsible person
11
for the existing listed brand of the pharmaceutical item;
12
(v) the drug is not on F2; or
13
(b) all of the following apply:
14
(i) the new brand of the trigger combination item is a new
15
presentation of an existing listed brand of a
16
pharmaceutical item;
17
(ii) the Minister has made a determination under
18
section 99ACEA in relation to the new brand of the
19
trigger combination item;
20
(iii) the determination under section 99ACEA has not ceased
21
to have effect.
22
7 At the end of Subdivision C of Division 3A of Part VII
23
Add:
24
99ACEA Ministerial determination--brand of pharmaceutical item
25
that is a combination item is not a new brand
26
(1) If:
27
(a) a brand of a pharmaceutical item (the trigger combination
28
item) is a combination item; and
29
(b) the brand of the trigger combination item is a new
30
presentation of an existing listed brand of a pharmaceutical
31
item; and
32
(c) a declaration under subsection 85(2) is in force in relation to
33
the drug in the pharmaceutical item; and
34
Schedule 4 New brands
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National Health Amendment (Pharmaceutical Benefits--Budget and
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No. , 2017
(d) the Minister is satisfied that the determination day in relation
1
to the brand of the trigger combination item is after the fifth
2
anniversary, and before the tenth anniversary, of the
3
declaration under subsection 85(2) being made;
4
the Minister may determine, by notifiable instrument, that the
5
brand of the trigger combination item is not a new brand for the
6
purposes of section 99ACD.
7
(2) If the Minister makes a determination under this section in relation
8
to the brand of the trigger combination item, it must be made
9
before the determination day in relation to the brand of the trigger
10
combination item.
11
(3) In making a determination, the Minister may have regard to:
12
(a) any advice given by the Pharmaceutical Benefits Advisory
13
Committee; and
14
(b) any information provided by the responsible person for the
15
brand of the trigger combination item; and
16
(c) any other matter that the Minister considers relevant.
17
(4) A determination made under this section ceases to have effect on
18
whichever is the earliest of the following:
19
(a) the tenth anniversary of the declaration under
20
subsection 85(2) being made;
21
(b) the day that the drug is on F2.
22
(5) In this section:
23
determination day has the same meaning as in
24
paragraph 99ACD(1)(a).
25
8 After subsection 101(4AC)
26
Insert:
27
Functions relating to determinations that brands are not new
28
brands
29
(4AD) The Pharmaceutical Benefits Advisory Committee may give advice
30
to the Minister in relation to whether the Minister should determine
31
that a brand of a pharmaceutical item is not a new brand for the
32
purposes of section 99ACB or 99ACD.
33
New brands Schedule 4
Amendments commencing 1 July 2022 Part 2
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
47
Part 2--Amendments commencing 1 July 2022
1
National Health Act 1953
2
9 Subsection 85AB(4A)
3
Repeal the subsection, substitute:
4
(4A) For the purposes of working out whether subsection (4) is satisfied,
5
a brand of a pharmaceutical item that has the drug is to be
6
disregarded if:
7
(a) before 1 July 2022, subsection 99ACB(3A) or (3B), as in
8
force before its repeal by the National Health Amendment
9
(Pharmaceutical Benefits--Budget and Other Measures) Act
10
2017, applied in relation to the brand of the pharmaceutical
11
item; and
12
(b) all of the following apply:
13
(i) another brand of the pharmaceutical item has not
14
become a listed brand;
15
(ii) the drug is not on F2;
16
(iii) the tenth anniversary of the drug in the pharmaceutical
17
item being on F1 has not occurred.
18
10 Subsection 99ACB(1)
19
Omit ", (3A) and (3B)", substitute "and (3A)".
20
11 Subsections 99ACB(3A) and (3B)
21
Repeal the subsections, substitute:
22
(3A) This section does not apply in relation to the new brand of the
23
trigger item if:
24
(a) the new brand of the trigger item is a new presentation of an
25
existing listed brand of a pharmaceutical item; and
26
(b) before 1 July 2022, subsection 99ACB(3A) or (3B), as in
27
force before its repeal by the National Health Amendment
28
(Pharmaceutical Benefits--Budget and Other Measures) Act
29
2017, applied in relation to the new brand of the trigger item;
30
and
31
Schedule 4 New brands
Part 2 Amendments commencing 1 July 2022
48
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
(c) all of the following apply:
1
(i) the drug is not on F2;
2
(ii) the tenth anniversary of the drug in the pharmaceutical
3
item being on F1 has not occurred;
4
(iii) another brand of the pharmaceutical item has not
5
become a listed brand.
6
12 Section 99ACBA
7
Repeal the section.
8
13 Subsection 99ACD(3)
9
Repeal the subsection, substitute:
10
(3) This section does not apply in relation to the new brand of the
11
trigger combination item if:
12
(a) the new brand of the trigger combination item is a new
13
presentation of an existing listed brand of a pharmaceutical
14
item; and
15
(b) before 1 July 2022, paragraph 99ACD(3)(a) or (b), as in
16
force before its repeal by the National Health Amendment
17
(Pharmaceutical Benefits--Budget and Other Measures) Act
18
2017, applied in relation to the new brand of the trigger
19
combination item; and
20
(c) both of the following apply:
21
(i) the tenth anniversary of the declaration under
22
subsection 85(2) relating to the drug in the
23
pharmaceutical item being made has not occurred;
24
(ii) the drug is not on F2.
25
14 Section 99ACEA
26
Repeal the section.
27
15 Subsection 101(4AD)
28
Repeal the subsection.
29
Pharmacy location rules Schedule 5
Australian Community Pharmacy Authority Part 1
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
49
Schedule 5--Pharmacy location rules
1
Part 1--Australian Community Pharmacy Authority
2
National Health Act 1953
3
1 Subsection 90(3C)
4
Repeal the subsection.
5
2 Section 99Y
6
Repeal the section.
7
Schedule 5 Pharmacy location rules
Part 2 Miscellaneous
50
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Part 2--Miscellaneous
1
National Health Act 1953
2
3 Subsection 84(1) (definition of subject to an outstanding
3
staged reduction)
4
Repeal the definition.
5
4 Subsections 99ACE(5), (5A) and (5B)
6
Omit "or (4)", substitute ", (4) or (4A)".
7
Name changes Schedule 6
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
51
Schedule 6--Name changes
1
2
National Health Act 1953
3
1 At the end of section 85
4
Add:
5
Alternative names or terminology
6
(11) The Minister may, by notifiable instrument, determine that, for the
7
purposes of this Part:
8
(a) more than one name is recognised for the same listed drug; or
9
(b) more than one description is recognised for the same form of
10
a listed drug; or
11
(c) more than one description is recognised for the same manner
12
of administration of a form of a listed drug.
13
(12) Without limiting subsection (11), the Minister may determine a
14
name or description as being used during a period of time, such as
15
before or after a specified date.
16
Schedule 7 Safety net
52
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Schedule 7--Safety net
1
2
National Health Act 1953
3
1 Subsection 84(1)
4
Insert:
5
value for safety net purposes means:
6
(a) for the supply of a pharmaceutical benefit--the amount
7
prescribed by regulations made for the purposes of
8
subsection 84C(1E); and
9
(b) for the supply of a repatriation benefit--the amount charged
10
for the supply; and
11
(c) for the supply of out-patient medication--the applicable
12
amount in relation to the supply.
13
2 Subsection 84AAA(1)
14
Omit "(whether or not that supply is a supply of a kind described in
15
paragraph 84C(4A)(a))".
16
3 At the end of subparagraph 84AAA(1)(b)(iii)
17
Add "and".
18
4 Paragraph 84AAA(1)(b)
19
Omit "whether or not the supply was a supply of the kind described in
20
paragraph 84C(4A)(a); and".
21
5 At the end of section 84AAA
22
Add:
23
(4) In this section, a reference to a pharmaceutical benefit includes a
24
reference to a repatriation pharmaceutical benefit.
25
6 Subsections 84C(1AA) and (1C)
26
Repeal the subsections, substitute:
27
(1AA) A person who has been, at any time during a relevant entitlement
28
period, a general patient is eligible to be issued with a concession
29
Safety net Schedule 7
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
53
card in respect of that period if the total value for safety net
1
purposes of supplies of pharmaceutical benefits, repatriation
2
pharmaceutical benefits and out-patient medication made:
3
(a) to the person during the period; or
4
(b) to the person and the person's family during the period;
5
is not less than the amount of the general patient safety net (within
6
the meaning of section 99F).
7
Note:
Supplies of pharmaceutical benefits may include supplies referred to
8
in subsections 99(2A), (2AB) and (2B).
9
(1B) A person is eligible to be issued with a concession card at the time
10
of the supply of a pharmaceutical benefit, repatriation
11
pharmaceutical benefit or out-patient medication to the person or a
12
member of the person's family, if including the value for safety net
13
purposes of the supply in the total mentioned in subsection (1AA)
14
would fulfil that subsection.
15
(1C) A person who has been, at any time during a relevant entitlement
16
period, a concessional beneficiary is eligible to be issued with an
17
entitlement card in respect of that period if either of the following
18
paragraphs applies:
19
(a) the total of:
20
(i) the value for safety net purposes of supplies of
21
pharmaceutical benefits, repatriation pharmaceutical
22
benefits and out-patient medication made to the person
23
during the relevant entitlement period when the person
24
was a concessional beneficiary; and
25
(ii) where the person has, during the relevant entitlement
26
period, been a general patient--the transferred value of
27
supplies of pharmaceutical benefits, repatriation
28
pharmaceutical benefits and out-patient medication
29
made to the person during the period when the person
30
was a general patient;
31
is not less than the amount of the concessional beneficiary
32
safety net (within the meaning of section 99F);
33
(b) the total of:
34
(i) the value for safety net purposes of supplies of
35
pharmaceutical benefits, repatriation pharmaceutical
36
benefits and out-patient medication made to the person
37
and the person's family during the relevant entitlement
38
Schedule 7 Safety net
54
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
period when the person was a concessional beneficiary;
1
and
2
(ii) where the person has, during the relevant entitlement
3
period, been a general patient--the transferred value of
4
supplies of pharmaceutical benefits, repatriation
5
pharmaceutical benefits and out-patient medication
6
made to the person and the person's family during the
7
period when the person was a general patient;
8
is not less than the amount of the concessional beneficiary
9
safety net (within the meaning of section 99F).
10
Note:
Supplies of pharmaceutical benefits may include supplies referred to
11
in subsections 99(2A), (2AB) and (2B).
12
(1D) A person is eligible to be issued with an entitlement card at the
13
time of the supply of a pharmaceutical benefit, repatriation
14
pharmaceutical benefit or out-patient medication to the person or a
15
member of the person's family if:
16
(a) where the person is a concessional beneficiary at the time of
17
the supply--including the value for safety net purposes of the
18
supply; or
19
(b) where the person is a general patient at the time of the
20
supply--including the transferred value of the supply;
21
in the total mentioned in paragraph (1C)(a) or (b) would fulfil that
22
paragraph.
23
(1E) The regulations may prescribe the value for safety net purposes of
24
a supply of a pharmaceutical benefit.
25
(1F) Regulations made for the purposes of subsection (1E) must take
26
into account the amount charged for the supply, but may make
27
adjustments to the value for safety net purposes such as:
28
(a) excluding certain components of the amount charged; or
29
(b) setting a maximum limit on the value.
30
7 At the end of subparagraph 84C(4)(a)(ii)
31
Add "and".
32
8 Paragraph 84C(4)(b)
33
Omit all the words after "supply,", substitute "the person is not a holder
34
of an entitlement card; and".
35
Safety net Schedule 7
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
55
9 Paragraphs 84C(4)(c) to (e)
1
Repeal the paragraphs, substitute:
2
(c) in a case where the supply is made upon a general benefit
3
prescription and the Commonwealth price for the
4
pharmaceutical benefit exceeds $28.60--the amount received
5
in respect of the supply is equal to the sum of the following:
6
(i) $28.60 (less any allowable discount);
7
(ii) if an amount may be charged for the supply under
8
subsection 87(2A)--that amount;
9
(iii) any charge for supply at a time outside normal trading
10
hours;
11
(iv) any charge for delivery in accordance with regulations
12
made for the purposes of paragraph 87(4)(b); and
13
(d) in a case where the supply is made upon a concessional
14
benefit prescription and the Commonwealth price for the
15
pharmaceutical benefit exceeds $4.60--the amount received
16
in respect of the supply is equal to the sum of the following:
17
(i) $4.60 (less any allowable discount);
18
(ii) if an amount may be charged for the supply under
19
subsection 87(2A)--that amount;
20
(iii) any charge for supply at a time outside normal trading
21
hours;
22
(iv) any charge for delivery in accordance with regulations
23
made for the purposes of paragraph 87(4)(b); and
24
(e) in a case where the supply is taken, because of
25
subsection 99(2A), (2AB) or (2B), to be a supply otherwise
26
than under this Part, the amount charged or received in
27
respect of the supply does not exceed the sum of the
28
following:
29
(i) the price worked out in accordance with a determination
30
in force under subsection (7) for the pharmaceutical
31
benefit;
32
(ii) any amount charged or received by reason only that the
33
supply was made at a time outside normal trading hours;
34
(iii) any amount charged or received in accordance with
35
regulations made for the purposes of
36
paragraph 87(4)(b).
37
Schedule 7 Safety net
56
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
10 Subsection 84C(4AA)
1
Omit all the words after "of this section", substitute "if it is an early
2
supply of a specified pharmaceutical benefit".
3
11 Subsection 84C(7)
4
Omit "this section", substitute "subparagraph (4)(e)(i)".
5
12 Section 84CA
6
Repeal the section, substitute:
7
84CA Transferred value
8
For the purposes of subsections 84C(1C) and (1D), the transferred
9
value for the supply of a pharmaceutical benefit, repatriation
10
pharmaceutical benefit or out-patient medication is:
11
(a) if the value for safety net purposes of the supply is less than
12
$4.60--that lesser amount; and
13
(b) in any other case--$4.60.
14
Note:
The figures expressed in this section in dollars are periodically
15
adjusted under section 99G.
16
13 Subsection 87(1)
17
Omit "a medical practitioner", substitute "an approved medical
18
practitioner".
19
14 Paragraph 87(2)(b)
20
Omit "has previously been charged, for supplies of pharmaceutical
21
benefits, an amount that is not less than the amount of the general
22
patient safety net (within the meaning of section 99F)", substitute "is
23
eligible to be issued with a concession card".
24
15 Paragraph 87(2)(c)
25
Repeal the paragraph.
26
16 Paragraph 87(2)(e)
27
Omit "or (c)".
28
Safety net Schedule 7
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
57
17 Subsection 87(2) (note)
1
Omit "Note", substitute "Note 1".
2
18 At the end of subsection 87(2)
3
Add:
4
Note 2:
For when a person is eligible to be issued with a concession card, see
5
subsection 84C(1AA).
6
19 Subsection 87(2AAA)
7
Omit "Paragraphs (2)(b) and (c) do not apply", substitute
8
"Paragraph (2)(b) does not apply".
9
20 Subsections 87(2AA) and (2AB)
10
Repeal the subsections.
11
21 At the end of subsection 87A(3)
12
Add:
13
Note:
For when a person is eligible to be issued with a concession or
14
entitlement card, see section 84C.
15
22 Subsection 99(2AB)
16
Omit "or (c)".
17
23 Section 99F (definition of general patient reduced charge)
18
Omit ", or (c)".
19
24 Transitional provision
--indexation of charges
20
(1)
The repeal and substitution of paragraph 84C(4)(c) of the National
21
Health Act 1953 by this Schedule does not affect the indexation of
22
general patient charge that has occurred in each year after 2005 under
23
Division 4A of Part VII of that Act, or the continuing operation of that
24
Division.
25
(2)
The repeal and substitution of paragraph 84C(4)(d) and section 84CA of
26
that Act by this Schedule does not affect the continued indexation of
27
concessional beneficiary charge that has occurred in each year after
28
2005 under Division 4A of Part VII of that Act, or the continuing
29
operation of that Division.
30
Schedule 8 Prescription and supply
58
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Schedule 8--Prescription and supply
1
2
National Health Act 1953
3
1 Subsection 86(1)
4
Omit "furnishing", substitute "provision".
5
2 Subsection 88(1)
6
Repeal the subsection, substitute:
7
(1) Subject to this Part, a medical practitioner is authorised to write a
8
prescription for the supply of any pharmaceutical benefit
9
determined from to time to time by the Minister, for the purposes
10
of this subsection, by legislative instrument.
11
3 Subsection 88(1A)
12
Omit "authorized", substitute "authorised".
13
4 After subsection 88(1E)
14
Insert:
15
(1EA) In deciding whether a prescription for the supply of a
16
pharmaceutical benefit should be authorised for the purposes of
17
subsection (1), (1A), (1C), (1D) or (1E), the Minister must have
18
regard to any advice given by the Pharmaceutical Benefits
19
Advisory Committee.
20
(1EB) The Minister is not required to determine, in relation to a
21
pharmaceutical benefit, that at least one kind of PBS prescriber is
22
authorised to write a prescription for the supply of the benefit.
23
Note:
Paragraph 89(b) lists provisions that may permit supply of a
24
pharmaceutical benefit other than on presentation of a prescription.
25
5 Subsection 92A(3)
26
Omit "or an approved medical practitioner".
27
6 Subsection 93A(5)
28
Repeal the subsection, substitute:
29
Prescription and supply Schedule 8
No. , 2017
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
59
(5) A PBS prescriber may authorise a prescribed institution to supply a
1
pharmaceutical benefit to patients receiving treatment in the
2
institution if:
3
(a) the pharmaceutical benefit is covered by a determination
4
made under paragraph (2)(a); and
5
(b) the PBS prescriber is authorised under section 88 to write a
6
prescription for the supply of the pharmaceutical benefit.
7
7 After subsection 101(4AAC)
8
Insert:
9
Functions relating to determinations under section 88
10
(4AACAA) The Pharmaceutical Benefits Advisory Committee may give advice
11
to the Minister as to which PBS prescribers should be authorised to
12
write prescriptions for the supply of a pharmaceutical benefit.
13
8 Subsection 105AB(8)
14
Omit "or authority of a medical practitioner or a pharmacist or the
15
approval of a dental practitioner as a participating dental practitioner",
16
substitute "of a pharmacist".
17
9 Paragraph 139A(1)(de)
18
After "under section", insert "93,".
19
Schedule 9 Data collection
60
National Health Amendment (Pharmaceutical Benefits--Budget and
Other Measures) Bill 2017
No. , 2017
Schedule 9--Data collection
1
2
National Health Act 1953
3
1 Subsection 98AC(1)
4
After "subsection 99(2A),", insert "(2AB) or (2B),".
5