Commonwealth of Australia Bills
[Index]
[Search]
[Download]
[Related Items]
[Help]
This is a Bill, not an Act. For current law, see the Acts databases.
NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS SCHEME) BILL 2012
2010-2011-2012
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
National Health Amendment
(Pharmaceutical Benefits Scheme) Bill
2012
No. , 2012
(Health and Ageing)
A Bill for an Act to amend the National Health Act
1953, and for related purposes
i National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
Contents
1 Short
title
...........................................................................................
1
2 Commencement
.................................................................................
1
3 Schedule(s)
........................................................................................
1
Schedule 1--Approved ex-manufacturer price
3
Part 1--Amendments
3
National Health Act 1953
3
Part 2--Application, saving and transitional provisions
20
Division 1--Preliminary
20
Division 2--Converting approved price to pharmacists to approved
ex-manufacturer price of brands of pharmaceutical items
(other than single brands of combination items)
21
Division 3--Converting approved price to pharmacists to approved
ex-manufacturer price of single brands of combination
items
28
Division 4--Converting claimed prices of brands of pharmaceutical
items
29
Division 5--Other
31
Schedule 2--Price disclosure
34
Part 1--Amendments
34
National Health Act 1953
34
Part 2--Application provision
36
Schedule 3--Prescriber bag supplies
37
Part 1--Amendments
37
National Health Act 1953
37
Part 2--Application, saving and transitional provisions
42
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012 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 may be cited as the National Health Amendment
5
(Pharmaceutical Benefits Scheme) Act 2012.
6
2 Commencement
7
This Act commences on 1 October 2012.
8
3 Schedule(s)
9
Each Act that is specified in a Schedule to this Act is amended or
10
repealed as set out in the applicable items in the Schedule
11
2 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
concerned, and any other item in a Schedule to this Act has effect
1
according to its terms.
2
3
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
3
Schedule 1--Approved ex-manufacturer price
1
Part 1--Amendments
2
National Health Act 1953
3
1 Subsection 84(1)
4
Insert:
5
approved ex-manufacturer price of a listed brand of a
6
pharmaceutical item means:
7
(a) if a price agreement is in force in relation to the brand of the
8
pharmaceutical item--the amount in force under the
9
agreement as the amount that is, for the purposes of this Part,
10
taken to be the appropriate maximum price of the brand of
11
the pharmaceutical item; or
12
(b) if a price determination is in force in relation to the brand of
13
the pharmaceutical item--the amount in force under the
14
determination as the amount that is, for the purposes of this
15
Part, taken to be the appropriate maximum price of the brand
16
of the pharmaceutical item.
17
2 Subsection 84(1) (definition of approved price to
18
pharmacists)
19
Repeal the definition.
20
3 Subsection 84(1) (paragraphs (a) and (b) of the definition of
21
Commonwealth price)
22
After "Commonwealth price", insert "for the particular quantity or
23
number of units of the pharmaceutical benefit".
24
4 Subsection 84(1) (paragraph (c) of the definition of
25
Commonwealth price)
26
Omit "the benefit", insert "the particular quantity or number of units of
27
the pharmaceutical benefit".
28
5 Subsection 84(1)
29
Insert:
30
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
4 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
determined quantity of a listed brand of a pharmaceutical item: see
1
subsection 84AK(3).
2
6 Subsection 84(1)
3
Insert:
4
pack quantity of a listed brand of a pharmaceutical item: see
5
subsection 84AK(2).
6
7 Subsection 84(1)
7
Insert:
8
pricing quantity of a listed brand of a pharmaceutical item: see
9
subsection 84AK(1).
10
8 Subsection 84(1)
11
Insert:
12
proportional ex-manufacturer price of a listed brand of a
13
pharmaceutical item: see section 85D.
14
9 Subsection 84(1) (definition of special patient contribution)
15
Omit "85B(4)", substitute "85B(5)".
16
10 Subsection 84C(7)
17
Omit "the manner in which the price for", substitute ", by legislative
18
instrument, the manner in which the price for particular quantities or
19
numbers of units of".
20
11 Paragraph 84C(8)(a)
21
Omit "approved price to pharmacists", substitute "approved
22
ex-manufacturer price or a proportional ex-manufacturer price".
23
12 Subsection 84C(10)
24
Repeal the subsection.
25
13 At the end of Division 1 of Part VII
26
Add:
27
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
5
84AK Quantities of pharmaceutical items
1
Pricing quantity
2
(1)
The
pricing quantity of a listed brand of a pharmaceutical item is
3
the lowest of any pack quantity of any listed brand of the
4
pharmaceutical item.
5
Pack quantity
6
(2) The Minister may, by legislative instrument, determine for a listed
7
brand of a pharmaceutical item that one or more quantities or
8
numbers of units of the pharmaceutical item is a pack quantity of
9
the brand of the pharmaceutical item.
10
Determined quantity
11
(3) The Minister may, by legislative instrument, determine for a listed
12
brand of a pharmaceutical item that one or more quantities or
13
numbers of units of the pharmaceutical item is a determined
14
quantity of the brand of the pharmaceutical item.
15
14 Subsection 85AD(1)
16
Repeal the subsection, substitute:
17
(1) The Minister and the responsible person for a listed brand of a
18
pharmaceutical item may, from time to time, agree, by reference to
19
the pricing quantity of the brand of the pharmaceutical item, an
20
amount that is, for the purposes of this Part, taken to be the
21
appropriate maximum price of the brand of the pharmaceutical
22
item.
23
Note:
Section 85C and Division 3A limit the Minister's power to agree to
24
amounts for the purposes of subsection (1).
25
15 Subsection 85AD(2)
26
Omit all the words after paragraph (b), substitute:
27
; or (c) the quantity or number of units of the item is not yet a pricing
28
quantity; or
29
(d) the brand is not yet a listed brand.
30
However, those matters must be satisfied at the time the amount
31
referred to in subsection (1) comes into force.
32
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
6 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
16 Section 85B
1
Repeal the section, substitute:
2
85B Price determinations and special patient contributions
3
Application
4
(1) This section applies to a listed brand of a pharmaceutical item.
5
Price determination
6
(2) If the Minister and the responsible person have been unable to
7
make a price agreement for the brand of the pharmaceutical item,
8
then the Minister may, by legislative instrument, determine, by
9
reference to the pricing quantity of the listed brand of a
10
pharmaceutical item, an amount that is, for the purposes of this
11
Part, taken to be the appropriate maximum price of the brand of the
12
pharmaceutical item.
13
Note:
Section 85C and Division 3A limit the Minister's power to determine
14
amounts under subsection (2).
15
Claimed price determination
16
(3) The Minister may, by legislative instrument, determine, by
17
reference to a pack quantity of the listed brand of the
18
pharmaceutical item, an amount that is, for the purposes of this
19
Part, taken to be the price of the brand of the pharmaceutical item
20
claimed by the responsible person for that quantity.
21
Special patient contribution
22
(4) If the Minister makes a determination under subsection (3), then
23
the Minister may, by legislative instrument, determine the
24
circumstances in which the Commonwealth is to pay the special
25
patient contribution for the brand of the pharmaceutical item.
26
(5)
The
special patient contribution for a quantity or number of units
27
of a listed brand of a pharmaceutical item is the amount that is the
28
difference between:
29
(a) the price that would have been the Commonwealth price for
30
that quantity or number of units of the brand of the
31
pharmaceutical item if that Commonwealth price had been
32
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
7
based on the claimed price for that quantity or number of
1
units; and
2
(b) the Commonwealth price for that quantity or number of units
3
of the brand of the pharmaceutical item.
4
17 After section 85B
5
Insert:
6
85C Each brand of a pharmaceutical item is to have the same
7
approved ex-manufacturer price
8
If there are 2 or more listed brands of a pharmaceutical item, then
9
the Minister must ensure, when agreeing an amount under
10
subsection 85AD(1) or determining an amount under subsection
11
85B(2), that the approved ex-manufacturer price of each listed
12
brand of the pharmaceutical item is the same.
13
85D Proportional ex-manufacturer price
14
The
proportional ex-manufacturer price for a pack quantity (other
15
than the pricing quantity) of a listed brand of a pharmaceutical item
16
on a day is the amount worked out as follows:
17
AEMP
PkQ
PQ
×
18
where:
19
AEMP means the approved ex-manufacturer price of the brand of
20
the pharmaceutical item in force on that day.
21
PkQ means the pack quantity of the brand of the pharmaceutical
22
item on that day.
23
PQ means the pricing quantity of the brand of the pharmaceutical
24
item on that day.
25
18 Subsection 87(2A)
26
Omit "section 85B", substitute "subsection 85B(3)".
27
19 Paragraph 98B(1)(a)
28
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
8 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Omit "Commonwealth price of", substitute "Commonwealth price for
1
particular quantities or numbers of units of".
2
20 Paragraph 98B(2)(a)
3
Omit "approved price to pharmacists", substitute "approved
4
ex-manufacturer price or a proportional ex-manufacturer price".
5
21 Subsection 98B(3) (definition of approved price to
6
pharmacists)
7
Repeal the definition.
8
22 Paragraph 98C(1)(a)
9
Omit "Commonwealth price of", substitute "Commonwealth price for
10
particular quantities or numbers of units of".
11
23 Paragraph 99(2AA)(b)
12
Omit "85B(5)", substitute "85B(4)".
13
24 Subsection 99(4)
14
After "supply of", insert "particular quantities or numbers of units of".
15
25 Subsection 99ACB(5)
16
Omit "approved price to pharmacists", substitute "approved
17
ex-manufacturer price".
18
26 Subsection 99ACB(6)
19
Repeal the subsection, substitute:
20
Apportioning if pricing quantity changes
21
(6) If the pricing quantity of the existing brand of the existing item on
22
the day before the determination day is different from the pricing
23
quantity of the existing brand of the existing item on the
24
determination day, then, for the purposes of subsection (5), the
25
approved ex-manufacturer price of the existing brand of the
26
existing item on the day before the determination day is taken to be
27
the amount worked out as follows:
28
AEMP1
PQ2
PQ1
×
29
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
9
where:
1
AEMP1 means the amount that was the approved ex-manufacturer
2
price of the existing brand of the existing item on the day before
3
the determination day.
4
PQ1 means the pricing quantity of the existing brand of the
5
existing item on the day before the determination day.
6
PQ2 means the pricing quantity of the existing brand of the
7
existing item on the determination day.
8
27 Subparagraph 99ACC(4A)(d)(i)
9
Omit "approved price to pharmacists", substitute "approved
10
ex-manufacturer price".
11
28 Paragraph 99ACC(4B)(a)
12
Omit "approved price to pharmacists", substitute "approved
13
ex-manufacturer price".
14
29 Subsection 99ACD(5)
15
Omit "approved price to pharmacists", substitute "approved
16
ex-manufacturer price".
17
30 Paragraphs 99ACD(6)(b) and (c)
18
Omit "approved price to pharmacists", substitute "approved
19
ex-manufacturer price".
20
31 Subsection 99ACD(7)
21
Repeal the subsection, substitute:
22
Apportioning if pricing quantity changes
23
(7) If the pricing quantity of the existing brand of the existing item on
24
the day before the determination day is different from the pricing
25
quantity of the existing brand of the existing item on the
26
determination day, then, for the purposes of subsection (5), the
27
approved ex-manufacturer price of the existing brand of the
28
existing item on the day before the determination day is taken to be
29
the amount worked out as follows:
30
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
10 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
AEMP1
PQ2
PQ1
×
1
where:
2
AEMP1 means the amount that was the approved ex-manufacturer
3
price of the existing brand of the existing item on the day before
4
the determination day.
5
PQ1 means the pricing quantity of the existing brand of the
6
existing item on the day before the determination day.
7
PQ2 means the pricing quantity of the existing brand of the
8
existing item on the determination day.
9
32 Subsection 99ACE(2)
10
Omit "approved price to pharmacists", substitute "approved
11
ex-manufacturer price".
12
33 Subsection 99ACE(2)
13
Omit "The claimed price", substitute "Each claimed price".
14
34 Subparagraph 99ACE(3)(a)(ii)
15
Omit "(5), (5A) and (5B), does not exceed the agreed price", substitute
16
"(4B), (5), (5A) and (5B), does not exceed the approved
17
ex-manufacturer price".
18
35 Paragraph 99ACE(3)(b)
19
Omit "determination under section 85B for the related brand of the
20
related item, specify a determined price", substitute "price
21
determination, specify a determined price for the related brand of the
22
related item".
23
36 Subparagraph 99ACE(3)(b)(ii)
24
Omit "subsections (5), (5A) and (5B), does not exceed the agreed
25
price", substitute "subsections (4B), (5), (5A) and (5B), does not exceed
26
the approved ex-manufacturer price".
27
37 Subsection 99ACE(4)
28
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
11
Omit "If a determination under section 85B was in force for the related
1
brand of a related item", substitute "If a price determination was in
2
force for the related brand of the related item".
3
38 Paragraph 99ACE(4)(a)
4
Repeal the paragraph, substitute:
5
(a) in a price determination, specify a determined price for the
6
related brand of the related item that:
7
(i) comes into force on the reduction day; and
8
(ii) subject to subsections (4B), (5), (5A) and (5B), does not
9
exceed the approved ex-manufacturer price in force, on
10
the day before that day, for the related brand of the
11
related item, reduced by 16%; or
12
39 Paragraph 99ACE(4)(b)
13
Repeal the paragraph, substitute:
14
(b) in a price agreement, specify an agreed price for the related
15
brand of the related item that:
16
(i) comes into force on the reduction day; and
17
(ii) subject to subsections (4B), (5), (5A) and (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
40 After subsection 99ACE(4)
22
Insert:
23
(4A) If a determination under subsection 85B(3) was in force for a
24
particular pack quantity of the related brand of the related item on
25
the day before the reduction day, the Minister may, in a
26
determination under subsection 85B(3), specify a claimed price for
27
that pack quantity of the related brand of the related item that:
28
(a) comes into force on the reduction day; and
29
(b) subject to subsections (5), (5A) and (5B), does not exceed the
30
claimed price in force for that pack quantity of the related
31
brand of the related item on the day before that day, reduced
32
by 16%.
33
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
12 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Apportioning if pricing quantity changes
1
(4B) If the pricing quantity of the related brand of the related item on
2
the day before the reduction day is different from the pricing
3
quantity of the related brand of the related item on the reduction
4
day, then, for the purposes of subparagraphs (3)(a)(ii), (3)(b)(ii),
5
(4)(a)(ii) and (4)(b)(ii), the approved ex-manufacturer price of the
6
related brand of the related item on the day before the reduction
7
day is taken to be the amount worked out as follows:
8
AEMP1
PQ2
PQ1
×
9
where:
10
AEMP1 means the amount that was the approved ex-manufacturer
11
price of the related brand of the related item on the day before the
12
reduction day.
13
PQ1 means the pricing quantity of the related brand of the related
14
item on the day before the reduction day.
15
PQ2 means the pricing quantity of the related brand of the related
16
item on the reduction day.
17
41 Paragraphs 99ACE(5)(b) and (c)
18
Omit "approved price to pharmacists", substitute "approved
19
ex-manufacturer price".
20
42 Subsection 99ACEA(4)
21
Repeal the subsection, substitute:
22
(4) Subject to subsection (5), the agreed price of the new brand of the
23
trigger item that comes into force on the reduction day must not
24
exceed the approved ex-manufacturer price, on the day before the
25
reduction day, of the existing brand of the existing item, reduced
26
by the same amount that the approved ex-manufacturer price of the
27
existing brand of the existing item is reduced by on the reduction
28
day under item 6 or 7 of the table in section 99ACF.
29
43 Subsection 99ACEA(5)
30
Repeal the subsection, substitute:
31
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
13
Apportioning if pricing quantity changes
1
(5) If the pricing quantity of the existing brand of the existing item on
2
the day before the reduction day is different from the pricing
3
quantity of the existing brand of the existing item on the reduction
4
day, then, for the purposes of subsection (4), the approved
5
ex-manufacturer price of the existing brand of the existing item on
6
the day before the reduction day is taken to be the amount worked
7
out as follows:
8
AEMP1
PQ2
PQ1
×
9
where:
10
AEMP1 means the amount that was the approved ex-manufacturer
11
price of the existing brand of the existing item on the day before
12
the reduction day.
13
PQ1 means the pricing quantity of the existing brand of the
14
existing item on the day before the reduction day.
15
PQ2 means the pricing quantity of the existing brand of the
16
existing item on the reduction day.
17
44 Paragraph 99ACF(1)(c)
18
Repeal the paragraph, substitute:
19
(c) on the day before the reduction day, an approved
20
ex-manufacturer price was, or one or more claimed prices
21
were, in force for the listed brand of the pharmaceutical item;
22
45 Subsection 99ACF(1)
23
Omit "the agreed price is, or the determined price and the claimed price
24
are,", substitute "subject to subsection (2A), the approved
25
ex-manufacturer price is, and (if applicable) each of the claimed prices
26
are,".
27
46 Paragraph 99ACF(2)(b)
28
Before "on the reduction day", insert "subject to subsection (2A),".
29
47 Paragraph 99ACF(2)(b)
30
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
14 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Omit "approved price to pharmacists" (wherever occurring), substitute
1
"approved ex-manufacturer price".
2
48 Paragraph 99ACF(2)(c)
3
Repeal the paragraph, substitute:
4
(c) if, on the day before the reduction day and on the reduction
5
day, a determination under subsection 85B(3) was in force in
6
relation to a particular pack quantity of the listed brand of the
7
pharmaceutical item--the claimed price for that pack
8
quantity of the brand of the pharmaceutical item does not
9
exceed the claimed price for the same pack quantity of the
10
brand of the pharmaceutical item in force on the day before
11
the reduction day, reduced by more than the percentage or
12
amount specified in column 3 of the table for the section
13
referred to in column 2.
14
49 After subsection 99ACF(2)
15
Insert:
16
Apportioning if pricing quantity changes
17
(2A) If the pricing quantity of the listed brand of the pharmaceutical
18
item on the day before the reduction day is different from the
19
pricing quantity of the listed brand of the pharmaceutical item on
20
the reduction day, then, for the purposes of subsection (1) and
21
paragraph (2)(b), the approved ex-manufacturer price of the listed
22
brand of the pharmaceutical item on the day before the reduction
23
day is taken to be the amount worked out as follows:
24
AEMP1
PQ2
PQ1
×
25
where:
26
AEMP1 means the amount that was the approved ex-manufacturer
27
price of the listed brand of the pharmaceutical item on the day
28
before the reduction day.
29
PQ1 means the pricing quantity of the listed brand of the
30
pharmaceutical item on the day before the reduction day.
31
PQ2 means the pricing quantity of the listed brand of the
32
pharmaceutical item on the reduction day.
33
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
15
50 Paragraph 99ACF(3)(b)
1
Omit "the determined price and the claimed price, or the agreed price,",
2
substitute "the approved ex-manufacturer price, and (if applicable) each
3
claimed price,".
4
51 Subparagraph 99ACK(3)(b)(ii)
5
Repeal the subparagraph, substitute:
6
(ii) if, on the day before the reduction day concerned and on
7
the reduction day concerned, a determination under
8
subsection 85B(3) was in force in relation to a particular
9
pack quantity of the brand of the pharmaceutical item--
10
a percentage of the claimed price in force in relation to
11
that pack quantity of the brand of the pharmaceutical
12
item on the day before the reduction day concerned.
13
52 Section 99AD (last paragraph)
14
Omit "approved price to pharmacists", substitute "approved
15
ex-manufacturer price".
16
53 Subsection 99ADB(1) (definition of adjusted approved
17
price to pharmacists)
18
Repeal the definition.
19
54 Subsection 99ADB(1) (definition of agreed quantity)
20
Repeal the definition.
21
55 Subsection 99ADB(1) (definition of approved
22
ex-manufacturer price)
23
Repeal the definition.
24
56 Subsections 99ADB(2) and (3)
25
Repeal the subsections.
26
57 Subsection 99ADB(7)
27
Repeal the subsection, substitute:
28
(7) A determination made under subsection (4) in relation to a brand of
29
a pharmaceutical item may include the adjusted approved
30
ex-manufacturer price of the brand of the pharmaceutical item.
31
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
16 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
58 Subsection 99ADH(3)
1
Omit "approved price to pharmacists" (wherever occurring), substitute
2
"approved ex-manufacturer price".
3
59 At the end of subsection 99ADH(3)
4
Add:
5
Note:
If the pricing quantity of the brand of the pharmaceutical item on the
6
relevant day is different from the pricing quantity on the reduction
7
day, then, for the purposes of subsection (3), the adjusted approved
8
ex-manufacturer price of the brand of the pharmaceutical item is
9
worked out under subsection (4A).
10
60 Subsection 99ADH(4)
11
Repeal the subsection, substitute:
12
Claimed price reduction
13
(4) If, on the reduction day:
14
(a) a determination under subsection 85B(3) is in force in
15
relation to a particular pack quantity of the brand of the
16
pharmaceutical item; and
17
(b) the approved ex-manufacturer price of the brand of the
18
pharmaceutical item is reduced because of subsection (3);
19
then, on the reduction day the claimed price for that pack quantity
20
of the brand of the pharmaceutical item is taken to be reduced by
21
the percentage worked out as follows:
22
AEMP
AAEMP
100
AEMP
-
×
23
where:
24
AAEMP means the adjusted approved ex-manufacturer price of the
25
brand of the pharmaceutical item.
26
AEMP means the amount that would have been the approved
27
ex-manufacturer price of the brand of the pharmaceutical item on
28
the reduction day if the reduction under subsection (3) had not
29
occurred.
30
Note:
If the pricing quantity of the brand of the pharmaceutical item on the
31
relevant day is different from the pricing quantity on the reduction
32
day, then, for the purposes of subsection (4), the adjusted approved
33
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
17
ex-manufacturer price of the brand of the pharmaceutical item is
1
worked out under subsection (4A).
2
Apportioning if pricing quantity changes
3
(4A) If the pricing quantity of the brand of the pharmaceutical item on
4
the relevant day is different from the pricing quantity of the brand
5
of the pharmaceutical item on the reduction day, then, for the
6
purposes of subsections (3) and (4), the adjusted approved
7
ex-manufacturer price of the brand of the pharmaceutical item is
8
taken to be the amount worked out as follows:
9
WADP
PQ2
PQ1
×
10
where:
11
PQ1 means the pricing quantity of the brand of the pharmaceutical
12
item on the relevant day.
13
PQ2 means the pricing quantity of the brand of the pharmaceutical
14
item on the reduction day.
15
WADP means the amount equal to the amount of the weighted
16
average disclosed price of the brand of the pharmaceutical item.
17
61 After section 99ADH
18
Insert:
19
99ADHA Price reduction for brands listing after end of data
20
collection period
21
When this section applies
22
(1) This section applies if:
23
(a) a determination under subsection 85(6) is in force on the
24
reduction day in relation to a brand (the new brand) of a
25
pharmaceutical item (the existing item); and
26
(b) the determination came into force:
27
(i) after the last day of the period in respect of which the
28
weighted average disclosed price is determined for
29
another brand (the existing brand) of the existing item;
30
and
31
Schedule 1 Approved ex-manufacturer price
Part 1 Amendments
18 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
(ii) before the reduction day; and
1
(c) the approved ex-manufacturer price of the existing brand of
2
the existing item is reduced on the reduction day under
3
subsection 99ADH(3).
4
Price reduction
5
(2) On the reduction day, the approved ex-manufacturer price of the
6
new brand of the existing item is taken to be reduced to the same
7
amount as the approved ex-manufacturer price of the existing
8
brand of the existing item on that day.
9
Claimed price reduction
10
(3) If, on the reduction day:
11
(a) a determination under subsection 85B(3) is in force in
12
relation to a particular pack quantity of the new brand of the
13
existing item; and
14
(b) the approved ex-manufacturer price of the new brand of the
15
existing item is reduced because of subsection (2);
16
then, on the reduction day the claimed price for that pack quantity
17
of the new brand of the existing item is taken to be reduced by the
18
percentage worked out as follows:
19
AEMP1
AEMP2
100
AEMP1
-
×
20
where:
21
AEMP1 means the amount that would have been the approved
22
ex-manufacturer price of the new brand of the existing item on the
23
reduction day if the reduction under subsection (2) had not
24
occurred.
25
AEMP2 means the approved ex-manufacturer price of the new
26
brand of the existing item on the reduction day.
27
62 Paragraph 99AED(2)(d)
28
Omit "approved price to pharmacists", substitute "approved
29
ex-manufacturer price".
30
63 Section 99AEI (heading)
31
Approved ex-manufacturer price Schedule 1
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
19
Repeal the heading, substitute:
1
99AEI Minister may increase approved ex-manufacturer price if
2
guaranteed brand delisted
3
64 Paragraph 99AEI(2)(b)
4
Repeal the paragraph, substitute:
5
(b) under subsection 85B(2), make or vary a determination to
6
increase the determined price; or
7
(ba) under subsection 85B(3), make or vary a determination to
8
increase one or more claimed prices;
9
65 Subsection 99AEI(2)
10
Omit "approved price to pharmacists", substitute "approved
11
ex-manufacturer price".
12
13
Schedule 1 Approved ex-manufacturer price
Part 2 Application, saving and transitional provisions
20 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Part 2--Application, saving and transitional
1
provisions
2
Division 1--Preliminary
3
66 Definitions
4
In this Part:
5
approved ex-manufacturer price of a brand of a pharmaceutical item
6
on the commencement day means:
7
(a) if item 68 or 69 applies to the brand of the pharmaceutical
8
item--the amount worked out under item 70; and
9
(b) if items 68 and 69 do not apply to the brand of the
10
pharmaceutical item and a price agreement in relation to the
11
brand of the pharmaceutical item comes into force on the
12
commencement day under subsection 85AD(1) of the new
13
Act--the amount in force under that agreement; and
14
(c) if items 68 and 69 do not apply to the brand of the
15
pharmaceutical item and a price determination in relation to
16
the brand of the pharmaceutical item comes into force on the
17
commencement day under subsection 85B(2) of the new
18
Act--the amount in force under that determination.
19
Note:
For the purposes of paragraph (b), if item 73 applies to the brand of
20
the pharmaceutical item, the new price agreement will also need to
21
comply with the requirements of subitem 73(4).
22
approved price to pharmacists of a brand of a pharmaceutical item has
23
the same meaning as in subsection 98B(3) of the old Act.
24
commencement day means the day this Schedule commences.
25
determined quantity of a brand of a pharmaceutical item has the same
26
meaning as in subsection 84AK(3) of the new Act.
27
maximum quantity of a brand of a pharmaceutical item means any
28
maximum quantity or number of units for which there is a
29
determination in force under paragraph 85A(2)(a) of the new Act in
30
relation to the brand of the pharmaceutical item.
31
new Act means the National Health Act 1953 as amended by this Act.
32
old Act means the National Health Act 1953 as in force on the day
33
before the commencement day.
34
pack quantity of a brand of a pharmaceutical item has the same
35
meaning as in subsection 84AK(2) of the new Act.
36
Approved ex-manufacturer price Schedule 1
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
21
pricing quantity of a brand of a pharmaceutical item has the same
1
meaning as in subsection 84AK(1) of the new Act.
2
quantity of a brand of a pharmaceutical item means the quantity or
3
number of units of the brand of the pharmaceutical item.
4
section 100 only circumstances means circumstances determined in a
5
determination in force under paragraph 85(8)(b) of the new Act in
6
relation to a brand of a pharmaceutical item.
7
67 Rounding amounts
8
If an amount worked out under this Part is not a number of whole cents,
9
round the amount to the nearest cent (rounding 0.5 cents upwards).
10
Division 2--Converting approved price to pharmacists to
11
approved ex-manufacturer price of brands of
12
pharmaceutical items (other than single brands
13
of combination items)
14
68 Price agreements
15
(1)
Subject to item 72, this item applies if:
16
(a) a brand (the relevant brand) of a pharmaceutical item is a
17
listed brand of the pharmaceutical item on both the
18
commencement day and the day before that day; and
19
(b) a price agreement in relation to the relevant brand of the
20
pharmaceutical item is in force on the day before the
21
commencement day under subsection 85AD(1) of the old
22
Act.
23
Note:
Item 72 sets out situations when this item does not apply. One of those
24
situations is when the brand of the pharmaceutical item is a single
25
brand of a combination item (in which case, see item 73).
26
(2)
Despite the amendment made by item 14, on the commencement day:
27
(a) the price agreement is taken to continue in force (and may be
28
dealt with) on and after that day, as if it were made under
29
subsection 85AD(1) of the new Act; and
30
(b) the approved ex-manufacturer price of the brand of
31
pharmaceutical item on that day (see item 70) is taken to be
32
the amount in force under the agreement; and
33
Schedule 1 Approved ex-manufacturer price
Part 2 Application, saving and transitional provisions
22 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
(c) the pricing quantity of the brand of the pharmaceutical item
1
on that day is taken to be the quantity by reference to which
2
the amount was agreed.
3
69 Price determinations
4
(1)
Subject to item 72, this item applies if:
5
(a) a brand (the relevant brand) of a pharmaceutical item is a
6
listed brand of the pharmaceutical item on both the
7
commencement day and the day before that day; and
8
(b) a price determination in relation to the relevant brand of the
9
pharmaceutical item is in force on the day before the
10
commencement day under subsection 85B(2) of the old Act.
11
Note:
Item 72 sets out situations when this item does not apply. One of those
12
situations is when the brand of the pharmaceutical item is a single
13
brand of a combination item (in which case, see item 73).
14
(2)
Despite the amendment made by item 16, on the commencement day:
15
(a) the price determination is taken to continue in force (and may
16
be dealt with) on and after that day, as if it were made under
17
subsection 85B(2) of the new Act; and
18
(b) the approved ex-manufacturer price of the brand of
19
pharmaceutical item on that day (see item 70) is taken to be
20
the amount in force under the determination; and
21
(c) the pricing quantity of the brand of the pharmaceutical item
22
on that day is taken to be the quantity by reference to which
23
the amount was determined.
24
70 The approved ex-manufacturer price on the
25
commencement day
26
For the purposes of items 68 and 69, the approved ex-manufacturer
27
price of the relevant brand of the pharmaceutical item on the
28
commencement day is:
29
(a) if the regulations prescribe that an amount is to be the
30
approved ex-manufacturer price of the brand of the
31
pharmaceutical item on the commencement day--that
32
prescribed amount; and
33
(b) otherwise--the default approved ex-manufacturer price of
34
the brand of the pharmaceutical item (see item 71).
35
71 Working out the default approved ex-manufacturer price
36
Approved ex-manufacturer price Schedule 1
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
23
(1)
For the purposes of item 70, the default approved ex-manufacturer
1
price of the relevant brand of the pharmaceutical item is worked out as
2
follows.
3
Step 1--Identify the APP and agreed quantity
4
(2)
Identify the approved price to pharmacists (the relevant APP) of the
5
relevant brand of the pharmaceutical item on the day before the
6
commencement day, and the quantity (the agreed quantity) by reference
7
to which the relevant APP was agreed or determined.
8
Step 2--Work out the ex-manufacturer price for the agreed
9
quantity
10
(3)
List any maximum quantity or determined quantity on the
11
commencement day of each listed brand of the pharmaceutical item on
12
that day (other than any maximum quantity that relates to a supply of
13
any of those brands in section 100 only circumstances).
14
(4)
From that list, identify the relevant quantity of the relevant brand of the
15
pharmaceutical item, which is:
16
(a) the quantity that is the highest whole number multiple of the
17
agreed quantity of the relevant brand of the pharmaceutical
18
item from:
19
(i) any maximum quantity on the list; or
20
(ii) if subparagraph (a)(i) does not apply--any determined
21
quantity on the list; or
22
(b) if paragraph (a) does not apply--the quantity that is the
23
closest to the agreed quantity of the relevant brand of the
24
pharmaceutical item (or, if 2 quantities are equally close, the
25
higher of those quantities) from:
26
(i) any maximum quantity on the list; or
27
(ii) if subparagraph (b)(i) does not apply--any determined
28
quantity on the list.
29
(5) Work
out
the
price to pharmacists for the relevant quantity of the
30
relevant brand of the pharmaceutical item as follows:
31
APP
RQ
PTP
AQ
×
=
32
where:
33
Schedule 1 Approved ex-manufacturer price
Part 2 Application, saving and transitional provisions
24 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
APP means the relevant APP of the relevant brand of the
1
pharmaceutical item.
2
AQ means the agreed quantity of the relevant brand of the
3
pharmaceutical item.
4
PTP means the price to pharmacists for the relevant quantity of the
5
relevant brand of the pharmaceutical item.
6
RQ means the relevant quantity of the relevant brand of the
7
pharmaceutical item.
8
(6)
If the price to pharmacists for the relevant quantity of the relevant brand
9
of the pharmaceutical item is less than, or equal to, $1,000, then the
10
ex-manufacturer price for the agreed quantity of the relevant brand of
11
the pharmaceutical item is the amount worked out as follows:
12
APP
EMP
1.0752
=
13
where:
14
APP means the relevant APP of the relevant brand of the
15
pharmaceutical item.
16
EMP means the ex-manufacturer price for the agreed quantity of the
17
relevant brand of the pharmaceutical item.
18
(7) If:
19
(a) the price to pharmacists for the relevant quantity of the
20
relevant brand of the pharmaceutical item is more than
21
$1,000; and
22
(b) the relevant quantity and the agreed quantity of the relevant
23
brand of the pharmaceutical item are the same;
24
then the ex-manufacturer price for the agreed quantity of the relevant
25
brand of the pharmaceutical item is the amount worked out as follows:
26
EMP
APP
$69.94
=
-
27
where:
28
APP means the relevant APP of the relevant brand of the
29
pharmaceutical item.
30
EMP means the ex-manufacturer price for the agreed quantity of the
31
relevant brand of the pharmaceutical item.
32
(8) If:
33
Approved ex-manufacturer price Schedule 1
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
25
(a) the price to pharmacists for the relevant quantity of the
1
relevant brand of the pharmaceutical item is more than
2
$1,000; and
3
(b) the relevant quantity and the agreed quantity of the relevant
4
brand of the pharmaceutical item are not the same;
5
then the ex-manufacturer price for the agreed quantity of the relevant
6
brand of the pharmaceutical item is the amount worked out as follows:
7
AQ
EMP
APP
$69.94
RQ
=
-
×
8
where:
9
APP means the relevant APP of the relevant brand of the
10
pharmaceutical item.
11
AQ means the agreed quantity of the relevant brand of the
12
pharmaceutical item.
13
EMP means the ex-manufacturer price for the agreed quantity of the
14
relevant brand of the pharmaceutical item.
15
RQ means the relevant quantity of the relevant brand of the
16
pharmaceutical item.
17
Step 3--Work out the proportional ex-manufacturer price
18
(9) Work
out
the
proportional ex-manufacturer price for the pricing
19
quantity of the relevant brand of the pharmaceutical item on the
20
commencement day as follows:
21
EMP
PQ
PEMP
AQ
×
=
22
where:
23
AQ means the agreed quantity of the relevant brand of the
24
pharmaceutical item.
25
EMP means the ex-manufacturer price for the agreed quantity of the
26
relevant brand of the pharmaceutical item.
27
PEMP means the proportional ex-manufacturer price for the pricing
28
quantity of the relevant brand of the pharmaceutical item.
29
PQ means the pricing quantity of the relevant brand of the
30
pharmaceutical item on the commencement day.
31
Schedule 1 Approved ex-manufacturer price
Part 2 Application, saving and transitional provisions
26 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Step 4--Repeat steps 1 to 3 for each relevant brand
1
(10)
Repeat steps 1 to 3 above for each approved price to pharmacists of
2
each relevant brand of the pharmaceutical item on the day before the
3
commencement day.
4
Step 5--Work out the default approved ex-manufacturer price
5
(11) The
default approved ex-manufacturer price of the relevant brand of
6
the pharmaceutical item, and each of the relevant brands of the
7
pharmaceutical item, on the commencement day is:
8
(a) if, under subitem (9), there was only one proportional
9
ex-manufacturer price worked out for all of the relevant
10
brands of the pharmaceutical item--the amount worked out
11
under subitem (9); and
12
(b) if, under subitem (9), there was more than one proportional
13
ex-manufacturer price worked out for those brands:
14
(i) if the amount worked out under subitem (9) is the same
15
for all of those brands--that amount; or
16
(ii) otherwise--the lowest amount worked out under that
17
subitem for all of those brands.
18
72 When price agreements or determinations are not
19
preserved under item 68 or 69
20
(1)
Items 68 and 69 do not apply to continue in force a price agreement (the
21
relevant agreement) or price determination (the relevant
22
determination) in relation to a brand of a pharmaceutical item that was
23
in force on the day before the commencement day if:
24
(a) a new price agreement in relation to the brand of the
25
pharmaceutical item comes into force on the commencement
26
day under subsection 85AD(1) of the new Act; or
27
(b) a new price determination in relation to the brand of the
28
pharmaceutical item comes into force on the commencement
29
day under subsection 85B(2) of the new Act; or
30
(c) item 73 (which is about single brands of combination items)
31
applies to the brand of the pharmaceutical item; or
32
(d) both of the following subparagraphs apply:
33
(i) there was another price agreement or price
34
determination in relation to the brand of the
35
Approved ex-manufacturer price Schedule 1
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
27
pharmaceutical item in force on the day before the
1
commencement day;
2
(ii) the amount in force under that other agreement or
3
determination was agreed or determined by reference to
4
a quantity of the brand of the pharmaceutical item that is
5
equal to the pricing quantity of the brand of the
6
pharmaceutical item on the commencement day.
7
(2)
Item 68 also does not apply to continue in force the relevant agreement
8
if:
9
(a) there was another price agreement in relation to the brand of
10
the pharmaceutical item in force on the day before the
11
commencement day; and
12
(b) the amount in force under that other agreement was agreed
13
by reference to a quantity of the brand of the pharmaceutical
14
item that is less than the quantity by which the amount of the
15
relevant agreement was agreed.
16
(3)
Item 69 also does not apply to continue in force the relevant
17
determination if:
18
(a) there was a price agreement in relation to the brand of the
19
pharmaceutical item in force on the day before the
20
commencement day; or
21
(b) both of the following subparagraphs apply:
22
(i) there was another price determination in relation to the
23
brand of the pharmaceutical item in force on the day
24
before the commencement day;
25
(iii) the amount in force under that other determination was
26
determined by reference to a quantity of the brand of the
27
pharmaceutical item that is less than the quantity by
28
which the amount of the relevant determination was
29
determined.
30
(4)
If, because of subitem (1), (2) or (3), item 68 or 69 does not apply to
31
continue in force the relevant agreement or relevant determination, then
32
the relevant agreement or relevant determination ceases to have effect at
33
the end of the day before the commencement day.
34
Schedule 1 Approved ex-manufacturer price
Part 2 Application, saving and transitional provisions
28 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Division 3--Converting approved price to pharmacists to
1
approved ex-manufacturer price of single
2
brands of combination items
3
73 Price agreements for single brands of combination items
4
(1)
This item applies to a brand (the relevant brand) of a pharmaceutical
5
item that is a combination item if:
6
(a) on the commencement day, subsection 85AB(5) of the new
7
Act applies to the drug in a combination item; and
8
(b) on both the commencement day and the day before that day,
9
the relevant brand of the combination item is the only listed
10
brand of the combination item; and
11
(c) on the commencement day or the day before that day, there is
12
or was no listed brand of another combination item that:
13
(i) is bioequivalent or biosimilar to the relevant brand of
14
the combination item; and
15
(ii) has the same manner of administration as the relevant
16
brand of the combination item; and
17
(d) on the day before the commencement day, a price agreement
18
(the existing price agreement) was in force for the relevant
19
brand of the combination item.
20
(2)
The existing price agreement ceases to have effect at the end of the day
21
before the commencement day.
22
(3)
The Minister may make a new agreement under subsection 85AD(1) of
23
the new Act that comes into force on the commencement day.
24
(4)
For the purposes of subitem (3), in agreeing the approved
25
ex-manufacturer price of the relevant brand of the combination item
26
under the new agreement the Minister must take into account, in
27
relation to each listed component drug in the combination item:
28
(a) the approved ex-manufacturer price, on the commencement
29
day, of each brand of a pharmaceutical item that:
30
(i) has the listed component drug in the combination item;
31
and
32
(ii) has the same manner of administration as the relevant
33
brand of the combination item; and
34
(b) the quantity of the listed component drug in the combination
35
item.
36
Approved ex-manufacturer price Schedule 1
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
29
(5)
For the purposes of subitem (3), if the Pharmaceutical Benefits
1
Advisory Committee has given advice to the Minister under subsection
2
101(4AC) of the old Act in relation to the combination item, then the
3
Minister may take that advice into account in agreeing the approved
4
ex-manufacturer price of the relevant brand of the combination item
5
under the new agreement.
6
(6)
This item does not limit the Minister's powers, after the commencement
7
day, to make further price agreements in relation to the brand of the
8
combination item.
9
Division 4--Converting claimed prices of brands of
10
pharmaceutical items
11
74 Claimed prices
12
(1)
This item applies if:
13
(a) a brand (the relevant brand) of a pharmaceutical item is a
14
listed brand of the pharmaceutical item on both the
15
commencement day and the day before that day; and
16
(b) a determination in relation to a quantity of the relevant brand
17
of the pharmaceutical item is in force under subsection
18
85B(3) of the old Act on the day before the commencement
19
day; and
20
(c) the quantity is a pack quantity on the commencement day;
21
and
22
(d) a determination in relation to that quantity of the relevant
23
brand of the pharmaceutical item does not come into force on
24
the commencement day under subsection 85B(3) of the new
25
Act; and
26
(e) before the commencement day, the responsible person for the
27
brand does not notify the Minister, in writing, that the
28
responsible person does not claim a price for that quantity on
29
the commencement day.
30
(2)
Despite the amendment made by item 16, on the commencement day:
31
(a) the determination referred to in paragraph (1)(b) is taken to
32
continue in force (and may be dealt with) on and after that
33
day, as if it were made under subsection 85B(3) of the new
34
Act; and
35
Schedule 1 Approved ex-manufacturer price
Part 2 Application, saving and transitional provisions
30 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
(b) the claimed price for that quantity of the brand of
1
pharmaceutical item on that day (see item 75) is taken to be
2
the amount in force under the determination.
3
75 The claimed price on the commencement day
4
(1)
For the purposes of item 74, the claimed price for a quantity of the
5
relevant brand of the pharmaceutical item on the commencement day is
6
worked out as follows.
7
Step 1--Identify the claimed price and relevant quantity
8
(2) Identify:
9
(a) the amount (the old claimed price) specified in a
10
determination in force under subsection 85B(3) of the old Act
11
in relation to the relevant brand of the pharmaceutical item
12
on the day before the commencement day; and
13
(b) the quantity (the relevant quantity) by reference to which the
14
claimed price of the brand of the pharmaceutical item was
15
determined.
16
Step 2--Identify the old determined price for that quantity
17
(3)
Identify the amount (the old determined price) specified in a
18
determination in force under subsection 85B(2) of the old Act in
19
relation to the relevant quantity of the relevant brand of the
20
pharmaceutical item on the day before the commencement day.
21
Step 3--Identify the new price for that quantity
22
(4)
Identify the amount (the new price) for the relevant brand of the
23
pharmaceutical item, which is:
24
(a) if, on the commencement day, the relevant quantity is a
25
pricing quantity of the brand of the pharmaceutical item--the
26
approved ex-manufacturer price of the relevant brand of the
27
pharmaceutical item on the commencement day; and
28
(b) if, on the commencement day, the relevant quantity is not a
29
pricing quantity of the brand of the pharmaceutical item--the
30
proportional ex-manufacturer price for that quantity of the
31
relevant brand of the pharmaceutical item on the
32
commencement day worked out under section 85D of the
33
new Act.
34
Approved ex-manufacturer price Schedule 1
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
31
Step 4--Work out the percentage difference
1
(5)
Work out the percentage (the relevant percentage) by which the new
2
price is greater or lesser than the old determined price.
3
Step 5--Work out the claimed price
4
(6) The
claimed price for the relevant quantity of the relevant brand of the
5
pharmaceutical item on the commencement day is:
6
(a) if the new price is greater than the old determined price--the
7
old claimed price increased by the relevant percentage; and
8
(b) if the new price is less than the old determined price--the old
9
claimed price decreased by the relevant percentage; and
10
(c) if the new price is the same as the old determined price--the
11
old claimed price.
12
Division 5--Other
13
76 Application of amendments (other than those relating to
14
price disclosure)
15
The amendments made by Part 1 (other than items 52 to 61) of this
16
Schedule apply on and after the commencement day in relation to
17
supplies of pharmaceutical benefits made on or after that day.
18
77 Application of amendments and transitional provision
19
relating to price disclosure
20
Application
21
(1)
The amendments made by items 52 to 61 of this Schedule apply on and
22
after the commencement day in relation to supplies of pharmaceutical
23
benefits made before, on or after that day.
24
Transitional provision
25
(2)
The Minister may, for the purposes of determining the weighted
26
average disclosed price of the brand of the pharmaceutical item under
27
subsection 99ADB(4) of the new Act after the commencement day,
28
work out the amount of that weighted average disclosed price by
29
reference to information about supplies of pharmaceutical items before
30
or on the commencement day.
31
Schedule 1 Approved ex-manufacturer price
Part 2 Application, saving and transitional provisions
32 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
(3)
Subject to subitems (4) and (5), if:
1
(a) before the commencement day, the Minister determines the
2
weighted average disclosed price of the brand of the
3
pharmaceutical item under subsection 99ADB(4) of the old
4
Act; and
5
(b) before the commencement day, the Minister determines a
6
reduction day for the brand of the pharmaceutical item for the
7
purposes of section 99ADH of the old Act; and
8
(c) the reduction day is after the commencement day;
9
then, for the purposes of applying section 99ADH of the new Act to the
10
brand of the pharmaceutical item on or after the commencement day,
11
the adjusted approved ex-manufacturer price of the brand of the
12
pharmaceutical item on the reduction day referred to in paragraph (b) is
13
the amount equal to the amount of the weighted average disclosed price
14
of the brand of the pharmaceutical item referred to in paragraph (a).
15
(4)
If, on or after the commencement day, the Minister:
16
(a) revokes the determination referred to in paragraph (3)(a); and
17
(b) determines a new weighted average disclosed price of the
18
brand of the pharmaceutical item under subsection 99ADB(4)
19
of the new Act;
20
then a reference in subitem (3) to the weighted average disclosed price
21
of the brand of the pharmaceutical item is taken to be a reference to the
22
new weighted average disclosed price referred to in paragraph (a) of
23
this subitem.
24
(5)
If, on or after the commencement day, the Minister:
25
(a) revokes the determination referred to in paragraph (3)(b); and
26
(b) determines a new reduction day for the brand of the
27
pharmaceutical item for the purposes of section 99ADH of
28
the new Act;
29
then a reference in subitem (3) to the reduction day of the brand of the
30
pharmaceutical item is taken to be a reference to the new reduction day
31
referred to in paragraph (b) of this subitem.
32
78 Making price agreements before the commencement day
33
Section 4 of the Acts Interpretation Act 1901 applies in relation to the
34
power to make an agreement under subsection 85AD(1) of the new Act
35
in the same way it would apply if the power to make an agreement
36
under that subsection were a power to make an appointment.
37
Approved ex-manufacturer price Schedule 1
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
33
79 Reductions to the AEMP to include previous reductions to
1
the APP
2
On and after the commencement day, a reference to the approved
3
ex-manufacturer price of a brand of a pharmaceutical item in subsection
4
99ACD(6), 99ACE(5) or 99AEI(2) of the new Act is taken to include a
5
reference to the approved price to pharmacists of the brand of the
6
pharmaceutical item in force on any day before the commencement day.
7
80 Transitioning regulations made for paragraph 99ACK(3)(b)
8
Regulations that:
9
(a) were made for the purposes of paragraph 93ACK(3)(b) of the
10
old Act; and
11
(b) were in force immediately before the commencement day;
12
continue in force (and may be dealt with) on and after that day as if they
13
had been made for the purposes of paragraph 93ACK(3)(b) of the new
14
Act.
15
81 Regulations
16
(1)
The regulations may prescribe matters of a transitional nature (including
17
prescribing any saving or application provisions) relating to the
18
amendments and repeals made by this Schedule.
19
(2)
The Governor-General may make regulations prescribing matters:
20
(a) required or permitted by this Schedule to be prescribed; or
21
(b) necessary or convenient to be prescribed for carrying out or
22
giving effect to this Schedule.
23
24
Schedule 2 Price disclosure
Part 1 Amendments
34 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Schedule 2--Price disclosure
1
Part 1--Amendments
2
National Health Act 1953
3
1 Subsection 99ADB(1) (definition of adjusted approved
4
ex-manufacturer price)
5
Repeal the definition, substitute:
6
adjusted approved ex-manufacturer price of a brand of a
7
pharmaceutical item is the amount equal to the amount of the
8
weighted average disclosed price of the brand of the
9
pharmaceutical item.
10
2 Subsection 99ADB(1) (definition of applicable approved
11
ex-manufacturer price)
12
Repeal the definition, substitute:
13
applicable approved ex-manufacturer price: see subsection (3A).
14
3 Subsection 99ADB(1)
15
Insert:
16
relevant day means:
17
(a) if 30 September 2012 is the last day of the period in respect
18
of which the weighted average disclosed price of a brand of
19
the pharmaceutical item is determined--1 October 2012; and
20
(b) otherwise--the last day of the period in respect of which the
21
weighted average disclosed price of the brand of the
22
pharmaceutical item is determined.
23
4 Before subsection 99ADB(4)
24
Insert:
25
Applicable approved ex-manufacturer price
26
(3A) The applicable approved ex-manufacturer price of a brand of a
27
pharmaceutical item is the approved ex-manufacturer price of the
28
brand on the relevant day.
29
Price disclosure Schedule 2
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
35
(3B) For the purposes of subsection (3A), if:
1
(a) apart from this subsection, the brand of the pharmaceutical
2
item would not have an approved ex-manufacturer price on
3
the relevant day; and
4
(b) the brand of the pharmaceutical item has an approved
5
ex-manufacturer price before the first reduction day that:
6
(i) is determined under paragraph 99ADH(1)(aa) in relation
7
to the brand of the pharmaceutical item; and
8
(ii) occurs after the relevant day;
9
then:
10
(c) the regulations may prescribe the approved ex-manufacturer
11
price, or a method or formula for working out the approved
12
ex-manufacturer price, of the brand of the pharmaceutical
13
item on the relevant day; and
14
(d) if the regulations do so, the amount so worked out is taken to
15
be the approved ex-manufacturer price of the brand of the
16
pharmaceutical item on the relevant day.
17
5 Section 99ADJ
18
Repeal the section.
19
20
Schedule 2 Price disclosure
Part 2 Application provision
36 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Part 2--Application provision
1
6 Application provision
2
The amendments made by this Schedule apply on and after the day this
3
Schedule commences in relation to supplies of pharmaceutical benefits
4
made before, on or after that day.
5
6
Prescriber bag supplies Schedule 3
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
37
Schedule 3--Prescriber bag supplies
1
Part 1--Amendments
2
National Health Act 1953
3
1 Subsection 84(1)
4
Insert:
5
prescriber bag provisions means the following:
6
(a) section 93 (supplies by medical practitioners);
7
(b) section 93AA (supplies by authorised midwives);
8
(c) section 93AB (supplies by authorised nurse practitioners).
9
2 Subsection 85(1) (note 1)
10
Omit "(see section 85AA) can only be supplied under this Part",
11
substitute "(see sections 85AAA and 85AA) can only be supplied under
12
this Part under the prescriber bag provisions or".
13
3 After subsection 85(2)
14
Insert:
15
Drugs etc. that can only be supplied under the prescriber bag
16
provisions
17
(2AA)
If:
18
(a) the Minister makes a declaration under subsection (2) in
19
relation to a drug or medicinal preparation (the drug); and
20
(b) the Pharmaceutical Benefits Advisory Committee has
21
recommended under subsection 101(4AACA) that the drug
22
be supplied only under one or more of the prescriber bag
23
provisions;
24
then the Minister must, by legislative instrument, declare that the
25
drug can only be supplied under that provision or those provisions.
26
Note:
If the Minister makes a declaration in relation to a drug or medicinal
27
preparation under this subsection, the Minister cannot vary or revoke
28
that declaration without first satisfying the conditions set out in
29
subsection 101(4AACC).
30
4 After subsection 85(7)
31
Schedule 3 Prescriber bag supplies
Part 1 Amendments
38 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Insert:
1
Pharmaceutical benefits that can only be supplied under the
2
prescriber bag provisions
3
(7A) The Minister may, by legislative instrument, determine that a
4
particular pharmaceutical benefit can only be supplied under one or
5
more of the prescriber bag provisions.
6
5 After section 85
7
Insert:
8
85AAA Pharmaceutical benefits that can only be supplied under the
9
prescriber bag provisions
10
(1) If the Minister makes a declaration under subsection 85(2AA) in
11
relation to a drug or medicinal preparation (the drug) declaring that
12
the drug can only be supplied under one or more of the prescriber
13
bag provisions, then every pharmaceutical benefit that has that
14
drug can only be supplied under this Part under that provision or
15
those provisions.
16
(2) If the Minister makes a determination under subsection 85(7A) that
17
a particular pharmaceutical benefit can only be supplied under one
18
or more of the prescriber bag provisions, then that pharmaceutical
19
benefit can only be supplied under this Part under that provision or
20
those provisions.
21
(3) Despite subsections (1) and (2), if:
22
(a) the Minister makes a declaration under subsection 85(2AA)
23
declaring that a drug or medicinal preparation (the drug) can
24
only be supplied under one or more (but not all) of the
25
prescriber bag provisions (the drug prescriber bag
26
provision); and
27
(b) the Minister makes a determination under subsection 85(7A)
28
determining that a pharmaceutical benefit that has the drug
29
can only be supplied under a different prescriber bag
30
provision or different prescriber bag provisions (the
31
pharmaceutical benefit prescriber bag provision);
32
then the pharmaceutical benefit can only be supplied under this
33
Part under the drug prescriber bag provision and the
34
pharmaceutical benefit prescriber bag provision.
35
Prescriber bag supplies Schedule 3
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
39
6 Paragraph 89(b)
1
After "section 93AA,", insert "section 93AB,".
2
7 Section 93 (heading)
3
Repeal the heading, substitute:
4
93 Prescriber bag supplies--medical practitioners
5
8 Subsection 93(1)
6
After "Minister", insert ", by legislative instrument,".
7
9 Subsection 93(2)
8
After "Minister may", insert ", by legislative instrument,".
9
10 Subsection 93(2A)
10
Repeal the subsection.
11
11 Section 93AA
12
Repeal the section, substitute:
13
93AA Prescriber bag supplies--authorised midwives
14
(1) Except as prescribed by the regulations, an authorised midwife is
15
authorised to supply such pharmaceutical benefits as the Minister,
16
by legislative instrument, determines to persons who are entitled
17
under this Part to receive those pharmaceutical benefits.
18
(2) For the purposes of this section, the Minister may, by legislative
19
instrument, determine the maximum quantity or number of units of
20
a pharmaceutical benefit which may be obtained by an authorised
21
midwife during a specified period.
22
(3) The regulations may make provision for or in relation to the
23
obtaining of pharmaceutical benefits by an authorised midwife for
24
the purposes of this section.
25
(4) The regulations may make provision for or in relation to payments
26
by the Commonwealth in respect of the supply of pharmaceutical
27
benefits under this section.
28
Schedule 3 Prescriber bag supplies
Part 1 Amendments
40 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
93AB Prescriber bag supplies--authorised nurse practitioners
1
(1) Except as prescribed by the regulations, an authorised nurse
2
practitioner is authorised to supply such pharmaceutical benefits as
3
the Minister, by legislative instrument, determines to persons who
4
are entitled under this Part to receive those pharmaceutical
5
benefits.
6
(2) For the purposes of this section, the Minister may, by legislative
7
instrument, determine the maximum quantity or number of units of
8
a pharmaceutical benefit which may be obtained by an authorised
9
nurse practitioner during a specified period.
10
(3) The regulations may make provision for or in relation to the
11
obtaining of pharmaceutical benefits by an authorised nurse
12
practitioner for the purposes of this section.
13
(4) The regulations may make provision for or in relation to payments
14
by the Commonwealth in respect of the supply of pharmaceutical
15
benefits under this section.
16
12 After subsection 101(4AAC)
17
Insert:
18
Functions relating to declarations under subsection 85(2AA)
19
(4AACA) The Pharmaceutical Benefits Advisory Committee must make
20
recommendations to the Minister from time to time as to the drugs
21
and medicinal preparations which it considers should only be
22
supplied under one or more of the prescriber bag provisions.
23
(4AACB) The Minister may, by legislative instrument, revoke or vary a
24
declaration under subsection 85(2AA) in relation to a drug or
25
medicinal preparation.
26
(4AACC) If:
27
(a) under subsection (4AACB), the Minister proposes to revoke
28
or vary a declaration under subsection 85(2AA) declaring
29
that a drug or medicinal preparation (the drug) can only be
30
supplied under one or more of the prescriber bag provisions;
31
and
32
Prescriber bag supplies Schedule 3
Amendments Part 1
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
41
(b) on and after the day the revocation or variation comes into
1
force, the drug could be supplied under this Part otherwise
2
than under one or more of the prescriber bag provisions;
3
then the Minister can only make the revocation or variation if:
4
(c) the Minister also revokes or varies the declaration under
5
subsection 85(2), in accordance with subsections (4AAA),
6
(4AAB) and (4AAC) of this section, so that the drug ceases
7
to be a listed drug on and after the day the revocation or
8
variation of the subsection 85(2) declaration comes into
9
force; or
10
(d) the Pharmaceutical Benefits Advisory Committee
11
recommends against the Minister taking the action in
12
paragraph (c).
13
13 Subparagraph 133(1)(bc)(ii)
14
Omit "93AA", substitute "93AB".
15
14 Paragraph 134(4)(d)
16
Repeal the paragraph, substitute:
17
(d) an authority conferred upon an authorised midwife by
18
section 93AA;
19
(e) an authority conferred upon an authorised nurse practitioner
20
by section 93AB.
21
15 Paragraph 139A(1)(de)
22
After "93AA", insert "or 93AB".
23
24
Schedule 3 Prescriber bag supplies
Part 2 Application, saving and transitional provisions
42 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. ,
2012
Part 2--Application, saving and transitional
1
provisions
2
16 Definitions
3
In this Part:
4
commencement day means the day this Schedule commences.
5
National Health Act means the National Health Act 1953.
6
17 Application of amendments
7
The amendments made by this Schedule apply on and after the
8
commencement day in relation to supplies of pharmaceutical benefits
9
made on or after that day.
10
18 Transitioning subordinate legislation relating to prescriber
11
bag supplies
12
(1)
A legislative instrument that:
13
(a) was made for the purposes of subsection 85(2A) of the
14
National Health Act; and
15
(b) declared that the drug methoxyflurane can only be supplied
16
under special arrangements under section 100 of the National
17
Health Act; and
18
(c) was in force immediately before the commencement day;
19
continues in force (and may be dealt with) on and after that day as if:
20
(d) it had been made for the purposes of subsection 85(2AA) of
21
the National Health Act (as amended by this Act); and
22
(e) it declared that methoxyflurane can only be supplied under
23
section 93 of the National Health Act (as amended by this
24
Act).
25
(2) Regulations
that:
26
(a) were made for the purposes of section 93AA of the National
27
Health Act; and
28
(b) were in force immediately before the commencement day;
29
continue in force (and may be dealt with) on and after that day as if they
30
had been made for the purposes of sections 93AA and 93AB of the
31
National Health Act (as amended by this Act).
32
(3)
A legislative instrument that:
33
Prescriber bag supplies Schedule 3
Application, saving and transitional provisions Part 2
National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012 No. , 2012
43
(a) was made for the purposes of section 93AA of the National
1
Health Act; and
2
(b) was in force immediately before the commencement day;
3
continues in force (and may be dealt with) on and after that day as if it
4
had been made for the purposes of section 93AB of the National Health
5
Act (as amended by this Act).
6