Federal Register of Legislation - Australian Government

Primary content

Act No. 87 of 2012 as made
An Act to amend the National Health Act 1953, and for related purposes
Administered by: Health
Originating Bill: National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2012
Registered 04 Jul 2012
Date of Assent 28 Jun 2012
Table of contents.

 

 

 

 

 

 

National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012

 

No. 87, 2012

 

 

 

 

 

An Act to amend the National Health Act 1953, and for related purposes

  

  


Contents

1............ Short title............................................................................................. 1

2............ Commencement................................................................................... 2

3............ Schedule(s)......................................................................................... 2

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) Act 2012

No. 87, 2012

 

 

 

An Act to amend the National Health Act 1953, and for related purposes

[Assented to 28 June 2012]

The Parliament of Australia enacts:

1  Short title

                   This Act may be cited as the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012.

2  Commencement

                   This Act commences on 1 October 2012.

3  Schedule(s)

                   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 1Approved ex‑manufacturer price

Part 1Amendments

National Health Act 1953

1  Subsection 84(1)

Insert:

approved ex‑manufacturer price of a listed brand of a pharmaceutical item means:

                     (a)  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

                     (b)  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:

84AK  Quantities of pharmaceutical items

Pricing quantity

             (1)  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

             (2)  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

             (3)  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:

             (1)  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.

Note:          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

                     (d)  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:

85B  Price determinations and special patient contributions

Application

             (1)  This section applies to a listed brand of a pharmaceutical item.

Price determination

             (2)  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.

Note:          Section 85C and Division 3A limit the Minister’s power to determine amounts under subsection (2).

Claimed price determination

             (3)  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

             (4)  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.

             (5)  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:

                     (a)  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

                     (b)  the Commonwealth price for that quantity or number of units of the brand of the pharmaceutical item.

17  After section 85B

Insert:

85C  Each brand of a pharmaceutical item is to have the same approved ex‑manufacturer price

                   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.

85D  Proportional ex‑manufacturer price

                   The proportional ex‑manufacturer price for a pack quantity (other than the pricing quantity) of a listed brand of a pharmaceutical item on a day is the amount worked out as follows:

where:

AEMP means the approved ex‑manufacturer price of the brand of the pharmaceutical item in force on that day.

PkQ means the pack quantity of the brand of the pharmaceutical item on that day.

PQ means the pricing quantity of the brand of the pharmaceutical item on that day.

18  Subsection 87(2A)

Omit “section 85B”, substitute “subsection 85B(3)”.

19  Paragraph 98B(1)(a)

Omit “Commonwealth price of”, substitute “Commonwealth price for particular quantities or numbers of units of”.

20  Paragraph 98B(2)(a)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price or a proportional ex‑manufacturer price”.

21  Subsection 98B(3) (definition of approved price to pharmacists)

Repeal the definition.

22  Paragraph 98C(1)(a)

Omit “Commonwealth price of”, substitute “Commonwealth price for particular quantities or numbers of units of”.

23  Paragraph 99(2AA)(b)

Omit “85B(5)”, substitute “85B(4)”.

24  Subsection 99(4)

After “supply of”, insert “particular quantities or numbers of units of”.

25  Subsection 99ACB(5)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

26  Subsection 99ACB(6)

Repeal the subsection, substitute:

Apportioning if pricing quantity changes

             (6)  If the pricing quantity of the existing brand of the existing item on the day before the determination day is different from the pricing quantity of the existing brand of the existing item on the determination day, then, for the purposes of subsection (5), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day is taken to be the amount worked out as follows:

where:

AEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day.

PQ1 means the pricing quantity of the existing brand of the existing item on the day before the determination day.

PQ2 means the pricing quantity of the existing brand of the existing item on the determination day.

27  Subparagraph 99ACC(4A)(d)(i)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

28  Paragraph 99ACC(4B)(a)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

29  Subsection 99ACD(5)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

30  Paragraphs 99ACD(6)(b) and (c)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

31  Subsection 99ACD(7)

Repeal the subsection, substitute:

Apportioning if pricing quantity changes

             (7)  If the pricing quantity of the existing brand of the existing item on the day before the determination day is different from the pricing quantity of the existing brand of the existing item on the determination day, then, for the purposes of subsection (5), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day is taken to be the amount worked out as follows:

where:

AEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the determination day.

PQ1 means the pricing quantity of the existing brand of the existing item on the day before the determination day.

PQ2 means the pricing quantity of the existing brand of the existing item on the determination day.

32  Subsection 99ACE(2)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

33  Subsection 99ACE(2)

Omit “The claimed price”, substitute “Each claimed price”.

34  Subparagraph 99ACE(3)(a)(ii)

Omit “(5), (5A) and (5B), does not exceed the agreed price”, substitute “(4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price”.

35  Paragraph 99ACE(3)(b)

Omit “determination under section 85B for the related brand of the related item, specify a determined price”, substitute “price determination, specify a determined price for the related brand of the related item”.

36  Subparagraph 99ACE(3)(b)(ii)

Omit “subsections (5), (5A) and (5B), does not exceed the agreed price”, substitute “subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price”.

37  Subsection 99ACE(4)

Omit “If a determination under section 85B was in force for the related brand of a related item”, substitute “If a price determination was in force for the related brand of the related item”.

38  Paragraph 99ACE(4)(a)

Repeal the paragraph, substitute:

                     (a)  in a price determination, specify a determined price for the related brand of the related item that:

                              (i)  comes into force on the reduction day; and

                             (ii)  subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%; or

39  Paragraph 99ACE(4)(b)

Repeal the paragraph, substitute:

                     (b)  in a price agreement, specify an agreed price for the related brand of the related item that:

                              (i)  comes into force on the reduction day; and

                             (ii)  subject to subsections (4B), (5), (5A) and (5B), does not exceed the approved ex‑manufacturer price in force, on the day before that day, for the related brand of the related item, reduced by 16%.

40  After subsection 99ACE(4)

Insert:

          (4A)  If a determination under subsection 85B(3) was in force for a particular pack quantity of the related brand of the related item on the day before the reduction day, the Minister may, in a determination under subsection 85B(3), specify a claimed price for that pack quantity of the related brand of the related item that:

                     (a)  comes into force on the reduction day; and

                     (b)  subject to subsections (5), (5A) and (5B), does not exceed the claimed price in force for that pack quantity of the related brand of the related item on the day before that day, reduced by 16%.

Apportioning if pricing quantity changes

          (4B)  If the pricing quantity of the related brand of the related item on the day before the reduction day is different from the pricing quantity of the related brand of the related item on the reduction day, then, for the purposes of subparagraphs (3)(a)(ii), (3)(b)(ii), (4)(a)(ii) and (4)(b)(ii), the approved ex‑manufacturer price of the related brand of the related item on the day before the reduction day is taken to be the amount worked out as follows:

where:

AEMP1 means the amount that was the approved ex‑manufacturer price of the related brand of the related item on the day before the reduction day.

PQ1 means the pricing quantity of the related brand of the related item on the day before the reduction day.

PQ2 means the pricing quantity of the related brand of the related item on the reduction day.

41  Paragraphs 99ACE(5)(b) and (c)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

42  Subsection 99ACEA(4)

Repeal the subsection, substitute:

             (4)  Subject to subsection (5), the agreed price of the new brand of the trigger item that comes into force on the reduction day must not exceed the approved ex‑manufacturer price, on the day before the reduction day, of the existing brand of the existing item, reduced by the same amount that the approved ex‑manufacturer price of the existing brand of the existing item is reduced by on the reduction day under item 6 or 7 of the table in section 99ACF.

43  Subsection 99ACEA(5)

Repeal the subsection, substitute:

Apportioning if pricing quantity changes

             (5)  If the pricing quantity of the existing brand of the existing item on the day before the reduction day is different from the pricing quantity of the existing brand of the existing item on the reduction day, then, for the purposes of subsection (4), the approved ex‑manufacturer price of the existing brand of the existing item on the day before the reduction day is taken to be the amount worked out as follows:

where:

AEMP1 means the amount that was the approved ex‑manufacturer price of the existing brand of the existing item on the day before the reduction day.

PQ1 means the pricing quantity of the existing brand of the existing item on the day before the reduction day.

PQ2 means the pricing quantity of the existing brand of the existing item on the reduction day.

44  Paragraph 99ACF(1)(c)

Repeal the paragraph, substitute:

                     (c)  on the day before the reduction day, an approved ex‑manufacturer price was, or one or more claimed prices were, in force for the listed brand of the pharmaceutical item;

45  Subsection 99ACF(1)

Omit “the agreed price is, or the determined price and the claimed price are,”, substitute “subject to subsection (2A), the approved ex‑manufacturer price is, and (if applicable) each of the claimed prices are,”.

46  Paragraph 99ACF(2)(b)

Before “on the reduction day”, insert “subject to subsection (2A),”.

47  Paragraph 99ACF(2)(b)

Omit “approved price to pharmacists” (wherever occurring), substitute “approved ex‑manufacturer price”.

48  Paragraph 99ACF(2)(c)

Repeal the paragraph, substitute:

                     (c)  if, on the day before the reduction day and on the reduction day, a determination under subsection 85B(3) was in force in relation to a particular pack quantity of the listed brand of the pharmaceutical item—the claimed price for that pack quantity of the brand of the pharmaceutical item does not exceed the claimed price for the same pack quantity of the brand of the pharmaceutical item in force on the day before the reduction day, reduced by more than the percentage or amount specified in column 3 of the table for the section referred to in column 2.

49  After subsection 99ACF(2)

Insert:

Apportioning if pricing quantity changes

          (2A)  If the pricing quantity of the listed brand of the pharmaceutical item on the day before the reduction day is different from the pricing quantity of the listed brand of the pharmaceutical item on the reduction day, then, for the purposes of subsection (1) and paragraph (2)(b), the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the day before the reduction day is taken to be the amount worked out as follows:

where:

AEMP1 means the amount that was the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the day before the reduction day.

PQ1 means the pricing quantity of the listed brand of the pharmaceutical item on the day before the reduction day.

PQ2 means the pricing quantity of the listed brand of the pharmaceutical item on the reduction day.

50  Paragraph 99ACF(3)(b)

Omit “the determined price and the claimed price, or the agreed price,”, substitute “the approved ex‑manufacturer price, and (if applicable) each claimed price,”.

51  Subparagraph 99ACK(3)(b)(ii)

Repeal the subparagraph, substitute:

                             (ii)  if, on the day before the reduction day concerned and on the reduction day concerned, a determination under subsection 85B(3) was in force in relation to a particular pack quantity of the brand of the pharmaceutical item—a percentage of the claimed price in force in relation to that pack quantity of the brand of the pharmaceutical item on the day before the reduction day concerned.

52  Section 99AD (last paragraph)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.

53  Subsection 99ADB(1) (definition of adjusted approved price to pharmacists)

Repeal the definition.

54  Subsection 99ADB(1) (definition of agreed quantity)

Repeal the definition.

55  Subsection 99ADB(1) (definition of approved ex‑manufacturer price)

Repeal the definition.

56  Subsections 99ADB(2) and (3)

Repeal the subsections.

57  Subsection 99ADB(7)

Repeal the subsection, substitute:

             (7)  A determination made under subsection (4) in relation to a brand of a pharmaceutical item may include the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item.

58  Subsection 99ADH(3)

Omit “approved price to pharmacists” (wherever occurring), substitute “approved ex‑manufacturer price”.

59  At the end of subsection 99ADH(3)

Add:

Note:          If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity on the reduction day, then, for the purposes of subsection (3), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is worked out under subsection (4A).

60  Subsection 99ADH(4)

Repeal the subsection, substitute:

Claimed price reduction

             (4)  If, on the reduction day:

                     (a)  a determination under subsection 85B(3) is in force in relation to a particular pack quantity of the brand of the pharmaceutical item; and

                     (b)  the approved ex‑manufacturer price of the brand of the pharmaceutical item is reduced because of subsection (3);

then, on the reduction day the claimed price for that pack quantity of the brand of the pharmaceutical item is taken to be reduced by the percentage worked out as follows:

where:

AAEMP means the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item.

AEMP means the amount that would have been the approved ex‑manufacturer price of the brand of the pharmaceutical item on the reduction day if the reduction under subsection (3) had not occurred.

Note:          If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity on the reduction day, then, for the purposes of subsection (4), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is worked out under subsection (4A).

Apportioning if pricing quantity changes

          (4A)  If the pricing quantity of the brand of the pharmaceutical item on the relevant day is different from the pricing quantity of the brand of the pharmaceutical item on the reduction day, then, for the purposes of subsections (3) and (4), the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item is taken to be the amount worked out as follows:

where:

PQ1 means the pricing quantity of the brand of the pharmaceutical item on the relevant day.

PQ2 means the pricing quantity of the brand of the pharmaceutical item on the reduction day.

WADP means the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item.

61  After section 99ADH

Insert:

99ADHA  Price reduction for brands listing after end of data collection period

When this section applies

             (1)  This section applies if:

                     (a)  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

                     (b)  the determination came into force:

                              (i)  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

                             (ii)  before the reduction day; and

                     (c)  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

             (2)  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

             (3)  If, on the reduction day:

                     (a)  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

                     (b)  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:

99AEI  Minister may increase approved ex‑manufacturer price if guaranteed brand delisted

64  Paragraph 99AEI(2)(b)

Repeal the paragraph, substitute:

                     (b)  under subsection 85B(2), make or vary a determination to increase the determined price; or

                   (ba)  under subsection 85B(3), make or vary a determination to increase one or more claimed prices;

65  Subsection 99AEI(2)

Omit “approved price to pharmacists”, substitute “approved ex‑manufacturer price”.


 

Part 2Application, saving and transitional provisions

Division 1—Preliminary

66  Definitions

In this Part:

approved ex‑manufacturer price of a brand of a pharmaceutical item on the commencement day means:

                     (a)  if item 68 or 69 applies to the brand of the pharmaceutical item—the amount worked out under item 70; and

                     (b)  if items 68 and 69 do not apply to the brand of the pharmaceutical item and a price agreement in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85AD(1) of the new Act—the amount in force under that agreement; and

                     (c)  if items 68 and 69 do not apply to the brand of the pharmaceutical item and a price determination in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85B(2) of the new Act—the amount in force under that determination.

Note:          For the purposes of paragraph (b), if item 73 applies to the brand of the pharmaceutical item, the new price agreement will also need to comply with the requirements of subitem 73(4).

approved price to pharmacists of a brand of a pharmaceutical item has the same meaning as in subsection 98B(3) of the old Act.

commencement day means the day this Schedule commences.

determined quantity of a brand of a pharmaceutical item has the same meaning as in subsection 84AK(3) of the new Act.

maximum quantity of a brand of a pharmaceutical item means any maximum quantity or number of units for which there is a determination in force under paragraph 85A(2)(a) of the new Act in relation to the brand of the pharmaceutical item.

new Act means the National Health Act 1953 as amended by this Act.

old Act means the National Health Act 1953 as in force on the day before the commencement day.

pack quantity of a brand of a pharmaceutical item has the same meaning as in subsection 84AK(2) of the new Act.

pricing quantity of a brand of a pharmaceutical item has the same meaning as in subsection 84AK(1) of the new Act.

quantity of a brand of a pharmaceutical item means the quantity or number of units of the brand of the pharmaceutical item.

section 100 only circumstances means circumstances determined in a determination in force under paragraph 85(8)(b) of the new Act in relation to a brand of a pharmaceutical item.

67  Rounding amounts

If an amount worked out under this Part is not a number of whole cents, round the amount to the nearest cent (rounding 0.5 cents upwards).

Division 2—Converting approved price to pharmacists to approved ex‑manufacturer price of brands of pharmaceutical items (other than single brands of combination items)

68  Price agreements

(1)       Subject to item 72, this item applies if:

                     (a)  a brand (the relevant brand) of a pharmaceutical item is a listed brand of the pharmaceutical item on both the commencement day and the day before that day; and

                     (b)  a price agreement in relation to the relevant brand of the pharmaceutical item is in force on the day before the commencement day under subsection 85AD(1) of the old Act.

Note:          Item 72 sets out situations when this item does not apply. One of those situations is when the brand of the pharmaceutical item is a single brand of a combination item (in which case, see item 73).

(2)       Despite the amendment made by item 14, on the commencement day:

                     (a)  the price agreement is taken to continue in force (and may be dealt with) on and after that day, as if it were made under subsection 85AD(1) of the new Act; and

                     (b)  the approved ex‑manufacturer price of the brand of pharmaceutical item on that day (see item 70) is taken to be the amount in force under the agreement; and

                     (c)  the pricing quantity of the brand of the pharmaceutical item on that day is taken to be the quantity by reference to which the amount was agreed.

69  Price determinations

(1)       Subject to item 72, this item applies if:

                     (a)  a brand (the relevant brand) of a pharmaceutical item is a listed brand of the pharmaceutical item on both the commencement day and the day before that day; and

                     (b)  a price determination in relation to the relevant brand of the pharmaceutical item is in force on the day before the commencement day under subsection 85B(2) of the old Act.

Note:          Item 72 sets out situations when this item does not apply. One of those situations is when the brand of the pharmaceutical item is a single brand of a combination item (in which case, see item 73).

(2)       Despite the amendment made by item 16, on the commencement day:

                     (a)  the price determination is taken to continue in force (and may be dealt with) on and after that day, as if it were made under subsection 85B(2) of the new Act; and

                     (b)  the approved ex‑manufacturer price of the brand of pharmaceutical item on that day (see item 70) is taken to be the amount in force under the determination; and

                     (c)  the pricing quantity of the brand of the pharmaceutical item on that day is taken to be the quantity by reference to which the amount was determined.

70  The approved ex‑manufacturer price on the commencement day

For the purposes of items 68 and 69, the approved ex‑manufacturer price of the relevant brand of the pharmaceutical item on the commencement day is:

                     (a)  if the regulations prescribe that an amount is to be the approved ex‑manufacturer price of the brand of the pharmaceutical item on the commencement day—that prescribed amount; and

                     (b)  otherwise—the default approved ex‑manufacturer price of the brand of the pharmaceutical item (see item 71).

71  Working out the default approved ex‑manufacturer price

(1)       For the purposes of item 70, the default approved ex‑manufacturer price of the relevant brand of the pharmaceutical item is worked out as follows.

Step 1—Identify the APP and agreed quantity

(2)       Identify the approved price to pharmacists (the relevant APP) of the relevant brand of the pharmaceutical item on the day before the commencement day, and the quantity (the agreed quantity) by reference to which the relevant APP was agreed or determined.

Step 2—Work out the ex‑manufacturer price for the agreed quantity

(3)       List any maximum quantity or determined quantity on the commencement day of each listed brand of the pharmaceutical item on that day (other than any maximum quantity that relates to a supply of any of those brands in section 100 only circumstances).

(4)       From that list, identify the relevant quantity of the relevant brand of the pharmaceutical item, which is:

                     (a)  the quantity that is the highest whole number multiple of the agreed quantity of the relevant brand of the pharmaceutical item from:

                              (i)  any maximum quantity on the list; or

                             (ii)  if subparagraph (a)(i) does not apply—any determined quantity on the list; or

                     (b)  if paragraph (a) does not apply—the quantity that is the closest to the agreed quantity of the relevant brand of the pharmaceutical item (or, if 2 quantities are equally close, the higher of those quantities) from:

                              (i)  any maximum quantity on the list; or

                             (ii)  if subparagraph (b)(i) does not apply—any determined quantity on the list.

(5)       Work out the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item as follows:

where:

APP means the relevant APP of the relevant brand of the pharmaceutical item.

AQ means the agreed quantity of the relevant brand of the pharmaceutical item.

PTP means the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item.

RQ means the relevant quantity of the relevant brand of the pharmaceutical item.

(6)       If the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item is less than, or equal to, $1,000, then the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item is the amount worked out as follows:

where:

APP means the relevant APP of the relevant brand of the pharmaceutical item.

EMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.

(7)       If:

                     (a)  the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item is more than $1,000; and

                     (b)  the relevant quantity and the agreed quantity of the relevant brand of the pharmaceutical item are the same;

then the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item is the amount worked out as follows:

where:

APP means the relevant APP of the relevant brand of the pharmaceutical item.

EMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.

(8)       If:

                     (a)  the price to pharmacists for the relevant quantity of the relevant brand of the pharmaceutical item is more than $1,000; and

                     (b)  the relevant quantity and the agreed quantity of the relevant brand of the pharmaceutical item are not the same;

then the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item is the amount worked out as follows:

where:

APP means the relevant APP of the relevant brand of the pharmaceutical item.

AQ means the agreed quantity of the relevant brand of the pharmaceutical item.

EMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.

RQ means the relevant quantity of the relevant brand of the pharmaceutical item.

Step 3—Work out the proportional ex‑manufacturer price

(9)       Work out the proportional ex‑manufacturer price for the pricing quantity of the relevant brand of the pharmaceutical item on the commencement day as follows:

where:

AQ means the agreed quantity of the relevant brand of the pharmaceutical item.

EMP means the ex‑manufacturer price for the agreed quantity of the relevant brand of the pharmaceutical item.

PEMP means the proportional ex‑manufacturer price for the pricing quantity of the relevant brand of the pharmaceutical item.

PQ means the pricing quantity of the relevant brand of the pharmaceutical item on the commencement day.

Step 4—Repeat steps 1 to 3 for each relevant brand

(10)     Repeat steps 1 to 3 above for each approved price to pharmacists of each relevant brand of the pharmaceutical item on the day before the commencement day.

Step 5—Work out the default approved ex‑manufacturer price

(11)     The default approved ex‑manufacturer price of the relevant brand of the pharmaceutical item, and each of the relevant brands of the pharmaceutical item, on the commencement day is:

                     (a)  if, under subitem (9), there was only one proportional ex‑manufacturer price worked out for all of the relevant brands of the pharmaceutical item—the amount worked out under subitem (9); and

                     (b)  if, under subitem (9), there was more than one proportional ex‑manufacturer price worked out for those brands:

                              (i)  if the amount worked out under subitem (9) is the same for all of those brands—that amount; or

                             (ii)  otherwise—the lowest amount worked out under that subitem for all of those brands.

72  When price agreements or determinations are not preserved under item 68 or 69

(1)       Items 68 and 69 do not apply to continue in force a price agreement (the relevant agreement) or price determination (the relevant determination) in relation to a brand of a pharmaceutical item that was in force on the day before the commencement day if:

                     (a)  a new price agreement in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85AD(1) of the new Act; or

                     (b)  a new price determination in relation to the brand of the pharmaceutical item comes into force on the commencement day under subsection 85B(2) of the new Act; or

                     (c)  item 73 (which is about single brands of combination items) applies to the brand of the pharmaceutical item; or

                     (d)  both of the following subparagraphs apply:

                              (i)  there was another price agreement or price determination in relation to the brand of the pharmaceutical item in force on the day before the commencement day;

                             (ii)  the amount in force under that other agreement or determination was agreed or determined by reference to a quantity of the brand of the pharmaceutical item that is equal to the pricing quantity of the brand of the pharmaceutical item on the commencement day.

(2)       Item 68 also does not apply to continue in force the relevant agreement if:

                     (a)  there was another price agreement in relation to the brand of the pharmaceutical item in force on the day before the commencement day; and

                     (b)  the amount in force under that other agreement was agreed by reference to a quantity of the brand of the pharmaceutical item that is less than the quantity by which the amount of the relevant agreement was agreed.

(3)       Item 69 also does not apply to continue in force the relevant determination if:

                     (a)  there was a price agreement in relation to the brand of the pharmaceutical item in force on the day before the commencement day; or

                     (b)  both of the following subparagraphs apply:

                              (i)  there was another price determination in relation to the brand of the pharmaceutical item in force on the day before the commencement day;

                            (iii)  the amount in force under that other determination was determined by reference to a quantity of the brand of the pharmaceutical item that is less than the quantity by which the amount of the relevant determination was determined.

(4)       If, because of subitem (1), (2) or (3), item 68 or 69 does not apply to continue in force the relevant agreement or relevant determination, then the relevant agreement or relevant determination ceases to have effect at the end of the day before the commencement day.

Division 3—Converting approved price to pharmacists to approved ex‑manufacturer price of single brands of combination items

73  Price agreements for single brands of combination items

(1)       This item applies to a brand (the relevant brand) of a pharmaceutical item that is a combination item if:

                     (a)  on the commencement day, subsection 85AB(5) of the new Act applies to the drug in a combination item; and

                     (b)  on both the commencement day and the day before that day, the relevant brand of the combination item is the only listed brand of the combination item; and

                     (c)  on the commencement day or the day before that day, there is or was no listed brand of another combination item that:

                              (i)  is bioequivalent or biosimilar to the relevant brand of the combination item; and

                             (ii)  has the same manner of administration as the relevant brand of the combination item; and

                     (d)  on the day before the commencement day, a price agreement (the existing price agreement) was in force for the relevant brand of the combination item.

(2)       The existing price agreement ceases to have effect at the end of the day before the commencement day.

(3)       The Minister may make a new agreement under subsection 85AD(1) of the new Act that comes into force on the commencement day.

(4)       For the purposes of subitem (3), in agreeing the approved ex‑manufacturer price of the relevant brand of the combination item under the new agreement the Minister must take into account, in relation to each listed component drug in the combination item:

                     (a)  the approved ex‑manufacturer price, on the commencement day, of each brand of a pharmaceutical item that:

                              (i)  has the listed component drug in the combination item; and

                             (ii)  has the same manner of administration as the relevant brand of the combination item; and

                     (b)  the quantity of the listed component drug in the combination item.

(5)       For the purposes of subitem (3), if the Pharmaceutical Benefits Advisory Committee has given advice to the Minister under subsection 101(4AC) of the old Act in relation to the combination item, then the Minister may take that advice into account in agreeing the approved ex‑manufacturer price of the relevant brand of the combination item under the new agreement.

(6)       This item does not limit the Minister’s powers, after the commencement day, to make further price agreements in relation to the brand of the combination item.

Division 4—Converting claimed prices of brands of pharmaceutical items

74  Claimed prices

(1)       This item applies if:

                     (a)  a brand (the relevant brand) of a pharmaceutical item is a listed brand of the pharmaceutical item on both the commencement day and the day before that day; and

                     (b)  a determination in relation to a quantity of the relevant brand of the pharmaceutical item is in force under subsection 85B(3) of the old Act on the day before the commencement day; and

                     (c)  the quantity is a pack quantity on the commencement day; and

                     (d)  a determination in relation to that quantity of the relevant brand of the pharmaceutical item does not come into force on the commencement day under subsection 85B(3) of the new Act; and

                     (e)  before the commencement day, the responsible person for the brand does not notify the Minister, in writing, that the responsible person does not claim a price for that quantity on the commencement day.

(2)       Despite the amendment made by item 16, on the commencement day:

                     (a)  the determination referred to in paragraph (1)(b) is taken to continue in force (and may be dealt with) on and after that day, as if it were made under subsection 85B(3) of the new Act; and

                     (b)  the claimed price for that quantity of the brand of pharmaceutical item on that day (see item 75) is taken to be the amount in force under the determination.

75  The claimed price on the commencement day

(1)       For the purposes of item 74, the claimed price for a quantity of the relevant brand of the pharmaceutical item on the commencement day is worked out as follows.

Step 1—Identify the claimed price and relevant quantity

(2)       Identify:

                     (a)  the amount (the old claimed price) specified in a determination in force under subsection 85B(3) of the old Act in relation to the relevant brand of the pharmaceutical item on the day before the commencement day; and

                     (b)  the quantity (the relevant quantity) by reference to which the claimed price of the brand of the pharmaceutical item was determined.

Step 2—Identify the old determined price for that quantity

(3)       Identify the amount (the old determined price) specified in a determination in force under subsection 85B(2) of the old Act in relation to the relevant quantity of the relevant brand of the pharmaceutical item on the day before the commencement day.

Step 3—Identify the new price for that quantity

(4)       Identify the amount (the new price) for the relevant brand of the pharmaceutical item, which is:

                     (a)  if, on the commencement day, the relevant quantity is a pricing quantity of the brand of the pharmaceutical item—the approved ex‑manufacturer price of the relevant brand of the pharmaceutical item on the commencement day; and

                     (b)  if, on the commencement day, the relevant quantity is not a pricing quantity of the brand of the pharmaceutical item—the proportional ex‑manufacturer price for that quantity of the relevant brand of the pharmaceutical item on the commencement day worked out under section 85D of the new Act.

Step 4—Work out the percentage difference

(5)       Work out the percentage (the relevant percentage) by which the new price is greater or lesser than the old determined price.

Step 5—Work out the claimed price

(6)       The claimed price for the relevant quantity of the relevant brand of the pharmaceutical item on the commencement day is:

                     (a)  if the new price is greater than the old determined price—the old claimed price increased by the relevant percentage; and

                     (b)  if the new price is less than the old determined price—the old claimed price decreased by the relevant percentage; and

                     (c)  if the new price is the same as the old determined price—the old claimed price.

Division 5—Other

76  Application of amendments (other than those relating to price disclosure)

The amendments made by Part 1 (other than items 52 to 61) of this Schedule apply on and after the commencement day in relation to supplies of pharmaceutical benefits made on or after that day.

77  Application of amendments and transitional provision relating to price disclosure

Application

(1)       The amendments made by items 52 to 61 of this Schedule apply on and after the commencement day in relation to supplies of pharmaceutical benefits made before, on or after that day.

Transitional provision

(2)       The Minister may, for the purposes of determining the weighted average disclosed price of the brand of the pharmaceutical item under subsection 99ADB(4) of the new Act after the commencement day, work out the amount of that weighted average disclosed price by reference to information about supplies of pharmaceutical items before or on the commencement day.

(3)       Subject to subitems (4) and (5), if:

                     (a)  before the commencement day, the Minister determines the weighted average disclosed price of the brand of the pharmaceutical item under subsection 99ADB(4) of the old Act; and

                     (b)  before the commencement day, the Minister determines a reduction day for the brand of the pharmaceutical item for the purposes of section 99ADH of the old Act; and

                     (c)  the reduction day is after the commencement day;

then, for the purposes of applying section 99ADH of the new Act to the brand of the pharmaceutical item on or after the commencement day, the adjusted approved ex‑manufacturer price of the brand of the pharmaceutical item on the reduction day referred to in paragraph (b) is the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item referred to in paragraph (a).

(4)       If, on or after the commencement day, the Minister:

                     (a)  revokes the determination referred to in paragraph (3)(a); and

                     (b)  determines a new weighted average disclosed price of the brand of the pharmaceutical item under subsection 99ADB(4) of the new Act;

then a reference in subitem (3) to the weighted average disclosed price of the brand of the pharmaceutical item is taken to be a reference to the new weighted average disclosed price referred to in paragraph (a) of this subitem.

(5)       If, on or after the commencement day, the Minister:

                     (a)  revokes the determination referred to in paragraph (3)(b); and

                     (b)  determines a new reduction day for the brand of the pharmaceutical item for the purposes of section 99ADH of the new Act;

then a reference in subitem (3) to the reduction day of the brand of the pharmaceutical item is taken to be a reference to the new reduction day referred to in paragraph (b) of this subitem.

78  Making price agreements before the commencement day

Section 4 of the Acts Interpretation Act 1901 applies in relation to the power to make an agreement under subsection 85AD(1) of the new Act in the same way it would apply if the power to make an agreement under that subsection were a power to make an appointment.

79  Reductions to the AEMP to include previous reductions to the APP

On and after the commencement day, a reference to the approved ex‑manufacturer price of a brand of a pharmaceutical item in subsection 99ACD(6), 99ACE(5) or 99AEI(2) of the new Act is taken to include a reference to the approved price to pharmacists of the brand of the pharmaceutical item in force on any day before the commencement day.

80  Transitioning regulations made for paragraph 99ACK(3)(b)

Regulations that:

                     (a)  were made for the purposes of paragraph 93ACK(3)(b) of the old Act; and

                     (b)  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 paragraph 93ACK(3)(b) of the new Act.

81  Regulations

(1)       The regulations may prescribe matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments and repeals made by this Schedule.

(2)       The Governor‑General may make regulations prescribing matters:

                     (a)  required or permitted by this Schedule to be prescribed; or

                     (b)  necessary or convenient to be prescribed for carrying out or giving effect to this Schedule.


 

Schedule 2Price disclosure

Part 1Amendments

National Health Act 1953

1  Subsection 99ADB(1) (definition of adjusted approved ex‑manufacturer price)

Repeal the definition, substitute:

adjusted approved ex‑manufacturer price of a brand of a pharmaceutical item is the amount equal to the amount of the weighted average disclosed price of the brand of the pharmaceutical item.

2  Subsection 99ADB(1) (definition of applicable approved ex‑manufacturer price)

Repeal the definition, substitute:

applicable approved ex‑manufacturer price: see subsection (3A).

3  Subsection 99ADB(1)

Insert:

relevant day means:

                     (a)  if 30 September 2012 is the last day of the period in respect of which the weighted average disclosed price of a brand of the pharmaceutical item is determined—1 October 2012; and

                     (b)  otherwise—the last day of the period in respect of which the weighted average disclosed price of the brand of the pharmaceutical item is determined.

4  Before subsection 99ADB(4)

Insert:

Applicable approved ex‑manufacturer price

          (3A)  The applicable approved ex‑manufacturer price of a brand of a pharmaceutical item is the approved ex‑manufacturer price of the brand on the relevant day.

          (3B)  For the purposes of subsection (3A), if:

                     (a)  apart from this subsection, the brand of the pharmaceutical item would not have an approved ex‑manufacturer price on the relevant day; and

                     (b)  the brand of the pharmaceutical item has an approved ex‑manufacturer price before the first reduction day that:

                              (i)  is determined under paragraph 99ADH(1)(aa) in relation to the brand of the pharmaceutical item; and

                             (ii)  occurs after the relevant day;

then:

                     (c)  the regulations may prescribe the approved ex‑manufacturer price, or a method or formula for working out the approved ex‑manufacturer price, of the brand of the pharmaceutical item on the relevant day; and

                     (d)  if the regulations do so, the amount so worked out is taken to be the approved ex‑manufacturer price of the brand of the pharmaceutical item on the relevant day.

5  Section 99ADJ

Repeal the section.


 

Part 2Application provision

6  Application provision

The amendments made by this Schedule apply on and after the day this Schedule commences in relation to supplies of pharmaceutical benefits made before, on or after that day.


 

Schedule 3Prescriber bag supplies

Part 1Amendments

National Health Act 1953

1  Subsection 84(1)

Insert:

prescriber bag provisions means the following:

                     (a)  section 93 (supplies by medical practitioners);

                     (b)  section 93AA (supplies by authorised midwives);

                     (c)  section 93AB (supplies by authorised nurse practitioners).

2  Subsection 85(1) (note 1)

Omit “(see section 85AA) can only be supplied under this Part”, substitute “(see sections 85AAA and 85AA) can only be supplied under this Part under the prescriber bag provisions or”.

3  After subsection 85(2)

Insert:

Drugs etc. that can only be supplied under the prescriber bag provisions

       (2AA)  If:

                     (a)  the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and

                     (b)  the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AACA) that the drug be supplied only under one or more of the prescriber bag provisions;

then the Minister must, by legislative instrument, declare that the drug can only be supplied under that provision or those provisions.

Note:          If the Minister makes a declaration in relation to a drug or medicinal preparation under this subsection, the Minister cannot vary or revoke that declaration without first satisfying the conditions set out in subsection 101(4AACC).

4  After subsection 85(7)

Insert:

Pharmaceutical benefits that can only be supplied under the prescriber bag provisions

          (7A)  The Minister may, by legislative instrument, determine that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions.

5  After section 85

Insert:

85AAA  Pharmaceutical benefits that can only be supplied under the prescriber bag provisions

             (1)  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.

             (2)  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.

             (3)  Despite subsections (1) and (2), if:

                     (a)  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

                     (b)  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:

93  Prescriber bag supplies—medical practitioners

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:

93AA  Prescriber bag supplies—authorised midwives

             (1)  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.

             (2)  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.

             (3)  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.

             (4)  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.

93AB  Prescriber bag supplies—authorised nurse practitioners

             (1)  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.

             (2)  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.

             (3)  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.

             (4)  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)

  (4AACA)  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.

  (4AACB)  The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation.

  (4AACC)  If:

                     (a)  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

                     (b)  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:

                     (c)  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

                     (d)  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:

                     (d)  an authority conferred upon an authorised midwife by section 93AA;

                     (e)  an authority conferred upon an authorised nurse practitioner by section 93AB.

15  Paragraph 139A(1)(de)

After “93AA”, insert “or 93AB”.


 

Part 2Application, 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

(1)       A legislative instrument that:

                     (a)  was made for the purposes of subsection 85(2A) of the National Health Act; and

                     (b)  declared that the drug methoxyflurane can only be supplied under special arrangements under section 100 of the National Health Act; and

                     (c)  was in force immediately before the commencement day;

continues in force (and may be dealt with) on and after that day as if:

                     (d)  it had been made for the purposes of subsection 85(2AA) of the National Health Act (as amended by this Act); and

                     (e)  it declared that methoxyflurane can only be supplied under section 93 of the National Health Act (as amended by this Act).

(2)       Regulations that:

                     (a)  were made for the purposes of section 93AA of the National Health Act; and

                     (b)  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).

(3)       A legislative instrument that:

                     (a)  was made for the purposes of section 93AA of the National Health Act; and

                     (b)  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)