1Short title
This Act may be cited as the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012.
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Bill homepage (APH)This Act may be cited as the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012.
This Act commences on 1 October 2012.
Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.
Schedule 1—Approved ex‑manufacturer price
Part 1—Amendments
National Health Act 1953
1 Subsection 84(1)
Insert:
approved ex‑manufacturer price of a listed brand of a pharmaceutical item means:
if a price agreement is in force in relation to the brand of the pharmaceutical item—the amount in force under the agreement as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item; or
if a price determination is in force in relation to the brand of the pharmaceutical item—the amount in force under the determination as the amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.
2 Subsection 84(1) (definition of approved price to pharmacists)
Repeal the definition.
3 Subsection 84(1) (paragraphs (a) and (b) of the definition of Commonwealth price)
After “Commonwealth price”, insert “for the particular quantity or number of units of the pharmaceutical benefit”.
4 Subsection 84(1) (paragraph (c) of the definition of Commonwealth price)
Omit “the benefit”, insert “the particular quantity or number of units of the pharmaceutical benefit”.
5 Subsection 84(1)
Insert:
determined quantity of a listed brand of a pharmaceutical item: see subsection 84AK(3).
6 Subsection 84(1)
Insert:
pack quantity of a listed brand of a pharmaceutical item: see subsection 84AK(2).
7 Subsection 84(1)
Insert:
pricing quantity of a listed brand of a pharmaceutical item: see subsection 84AK(1).
8 Subsection 84(1)
Insert:
proportional ex‑manufacturer price of a listed brand of a pharmaceutical item: see section 85D.
9 Subsection 84(1) (definition of special patient contribution)
Omit “85B(4)”, substitute “85B(5)”.
10 Subsection 84C(7)
Omit “the manner in which the price for”, substitute “, by legislative instrument, the manner in which the price for particular quantities or numbers of units of”.
11 Paragraph 84C(8)(a)
Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price or a proportional ex‑manufacturer price”.
12 Subsection 84C(10)
Repeal the subsection.
13 At the end of Division 1 of Part VII
Add:
Pricing quantity
The pricing quantity of a listed brand of a pharmaceutical item is the lowest of any pack quantity of any listed brand of the pharmaceutical item.
Pack quantity
The Minister may, by legislative instrument, determine for a listed brand of a pharmaceutical item that one or more quantities or numbers of units of the pharmaceutical item is a pack quantity of the brand of the pharmaceutical item.
Determined quantity
The Minister may, by legislative instrument, determine for a listed brand of a pharmaceutical item that one or more quantities or numbers of units of the pharmaceutical item is a determined quantity of the brand of the pharmaceutical item.
14 Subsection 85AD(1)
Repeal the subsection, substitute:
The Minister and the responsible person for a listed brand of a pharmaceutical item may, from time to time, agree, by reference to the pricing quantity of the brand of the pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.
Section 85C and Division 3A limit the Minister’s power to agree to amounts for the purposes of subsection (1).
15 Subsection 85AD(2)
Omit all the words after paragraph (b), substitute:
; or (c) the quantity or number of units of the item is not yet a pricing quantity; or
the brand is not yet a listed brand.
However, those matters must be satisfied at the time the amount referred to in subsection (1) comes into force.
16 Section 85B
Repeal the section, substitute:
Application
This section applies to a listed brand of a pharmaceutical item.
Price determination
If the Minister and the responsible person have been unable to make a price agreement for the brand of the pharmaceutical item, then the Minister may, by legislative instrument, determine, by reference to the pricing quantity of the listed brand of a pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the appropriate maximum price of the brand of the pharmaceutical item.
Section 85C and Division 3A limit the Minister’s power to determine amounts under subsection (2).
Claimed price determination
The Minister may, by legislative instrument, determine, by reference to a pack quantity of the listed brand of the pharmaceutical item, an amount that is, for the purposes of this Part, taken to be the price of the brand of the pharmaceutical item claimed by the responsible person for that quantity.
Special patient contribution
If the Minister makes a determination under subsection (3), then the Minister may, by legislative instrument, determine the circumstances in which the Commonwealth is to pay the special patient contribution for the brand of the pharmaceutical item.
The special patient contribution for a quantity or number of units of a listed brand of a pharmaceutical item is the amount that is the difference between:
the price that would have been the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item if that Commonwealth price had been based on the claimed price for that quantity or number of units; and
the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item.
17 After section 85B
Insert:
If there are 2 or more listed brands of a pharmaceutical item, then the Minister must ensure, when agreeing an amount under subsection 85AD(1) or determining an amount under subsection 85B(2), that the approved ex‑manufacturer price of each listed brand of the pharmaceutical item is the same.
When this section applies
This section applies if:
a determination under subsection 85(6) is in force on the reduction day in relation to a brand (the new brand) of a pharmaceutical item (the existing item); and
the determination came into force:
after the last day of the period in respect of which the weighted average disclosed price is determined for another brand (the existing brand) of the existing item; and
before the reduction day; and
the approved ex‑manufacturer price of the existing brand of the existing item is reduced on the reduction day under subsection 99ADH(3).
Price reduction
On the reduction day, the approved ex‑manufacturer price of the new brand of the existing item is taken to be reduced to the same amount as the approved ex‑manufacturer price of the existing brand of the existing item on that day.
Claimed price reduction
If, on the reduction day:
a determination under subsection 85B(3) is in force in relation to a particular pack quantity of the new brand of the existing item; and
the approved ex‑manufacturer price of the new brand of the existing item is reduced because of subsection (2);
then, on the reduction day the claimed price for that pack quantity of the new brand of the existing item is taken to be reduced by the percentage worked out as follows:
where:
AEMP1 means the amount that would have been the approved ex‑manufacturer price of the new brand of the existing item on the reduction day if the reduction under subsection (2) had not occurred.
AEMP2 means the approved ex‑manufacturer price of the new brand of the existing item on the reduction day.
62 Paragraph 99AED(2)(d)
Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.
63 Section 99AEI (heading)
Repeal the heading, substitute:
If the Minister makes a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation (the drug) declaring that the drug can only be supplied under one or more of the prescriber bag provisions, then every pharmaceutical benefit that has that drug can only be supplied under this Part under that provision or those provisions.
If the Minister makes a determination under subsection 85(7A) that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions, then that pharmaceutical benefit can only be supplied under this Part under that provision or those provisions.
Despite subsections (1) and (2), if:
the Minister makes a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more (but not all) of the prescriber bag provisions (the drug prescriber bag provision); and
the Minister makes a determination under subsection 85(7A) determining that a pharmaceutical benefit that has the drug can only be supplied under a different prescriber bag provision or different prescriber bag provisions (the pharmaceutical benefit prescriber bag provision);
then the pharmaceutical benefit can only be supplied under this Part under the drug prescriber bag provision and the pharmaceutical benefit prescriber bag provision.
6 Paragraph 89(b)
After “section 93AA,”, insert “section 93AB,”.
7 Section 93 (heading)
Repeal the heading, substitute:
8 Subsection 93(1)
After “Minister”, insert “, by legislative instrument,”.
9 Subsection 93(2)
After “Minister may”, insert “, by legislative instrument,”.
10 Subsection 93(2A)
Repeal the subsection.
11 Section 93AA
Repeal the section, substitute:
Except as prescribed by the regulations, an authorised midwife is authorised to supply such pharmaceutical benefits as the Minister, by legislative instrument, determines to persons who are entitled under this Part to receive those pharmaceutical benefits.
For the purposes of this section, the Minister may, by legislative instrument, determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by an authorised midwife during a specified period.
The regulations may make provision for or in relation to the obtaining of pharmaceutical benefits by an authorised midwife for the purposes of this section.
The regulations may make provision for or in relation to payments by the Commonwealth in respect of the supply of pharmaceutical benefits under this section.
Except as prescribed by the regulations, an authorised nurse practitioner is authorised to supply such pharmaceutical benefits as the Minister, by legislative instrument, determines to persons who are entitled under this Part to receive those pharmaceutical benefits.
For the purposes of this section, the Minister may, by legislative instrument, determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by an authorised nurse practitioner during a specified period.
The regulations may make provision for or in relation to the obtaining of pharmaceutical benefits by an authorised nurse practitioner for the purposes of this section.
The regulations may make provision for or in relation to payments by the Commonwealth in respect of the supply of pharmaceutical benefits under this section.
12 After subsection 101(4AAC)
Insert:
Functions relating to declarations under subsection 85(2AA)
The Pharmaceutical Benefits Advisory Committee must make recommendations to the Minister from time to time as to the drugs and medicinal preparations which it considers should only be supplied under one or more of the prescriber bag provisions.
The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation.
If:
under subsection (4AACB), the Minister proposes to revoke or vary a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more of the prescriber bag provisions; and
on and after the day the revocation or variation comes into force, the drug could be supplied under this Part otherwise than under one or more of the prescriber bag provisions;
then the Minister can only make the revocation or variation if:
the Minister also revokes or varies the declaration under subsection 85(2), in accordance with subsections (4AAA), (4AAB) and (4AAC) of this section, so that the drug ceases to be a listed drug on and after the day the revocation or variation of the subsection 85(2) declaration comes into force; or
the Pharmaceutical Benefits Advisory Committee recommends against the Minister taking the action in paragraph (c).
13 Subparagraph 133(1)(bc)(ii)
Omit “93AA”, substitute “93AB”.
14 Paragraph 134(4)(d)
Repeal the paragraph, substitute:
an authority conferred upon an authorised midwife by section 93AA;
an authority conferred upon an authorised nurse practitioner by section 93AB.
15 Paragraph 139A(1)(de)
After “93AA”, insert “or 93AB”.
Part 2—Application, saving and transitional provisions
16 Definitions
In this Part:
commencement day means the day this Schedule commences.
National Health Act means the National Health Act 1953.
17 Application of amendments
The amendments made by this Schedule apply on and after the commencement day in relation to supplies of pharmaceutical benefits made on or after that day.
18 Transitioning subordinate legislation relating to prescriber bag supplies
A legislative instrument that:
was made for the purposes of subsection 85(2A) of the National Health Act; and
declared that the drug methoxyflurane can only be supplied under special arrangements under section 100 of the National Health Act; and
was in force immediately before the commencement day;
continues in force (and may be dealt with) on and after that day as if:
it had been made for the purposes of subsection 85(2AA) of the National Health Act (as amended by this Act); and
it declared that methoxyflurane can only be supplied under section 93 of the National Health Act (as amended by this Act).
Regulations that:
were made for the purposes of section 93AA of the National Health Act; and
were in force immediately before the commencement day;
continue in force (and may be dealt with) on and after that day as if they had been made for the purposes of sections 93AA and 93AB of the National Health Act (as amended by this Act).
A legislative instrument that:
was made for the purposes of section 93AA of the National Health Act; and
was in force immediately before the commencement day;
continues in force (and may be dealt with) on and after that day as if it had been made for the purposes of section 93AB of the National Health Act (as amended by this Act).
[Minister’s second reading speech made in—
House of Representatives on 23 May 2012
Senate on 18 June 2012] (78/12)
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