National Health (Pharmaceutical benefits supplied by private hospitals) Amendment (Budget Measure) Determination 2019 (PB 56 of 2019) (Cth)

PB 56 of 2019

National Health (Pharmaceutical benefits supplied by private hospitals) Amendment (Budget Measure) Determination 2019

I, Adriana Platona, as delegate of the Minister for Health, make the following determination.

Dated   27 June 2019

Adriana Platona

First Assistant Secretary

Technology Assessment and Access Division

Department of Health

Contents

1............ Name............................................................................................................................. 1

2............ Commencement............................................................................................................. 1

3............ Authority....................................................................................................................... 1

4............ Schedules...................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Pharmaceutical benefits supplied by private hospitals) Determination 2010    2

1  Name

(1)  This instrument is the National Health (Pharmaceutical benefits supplied by private hospitals) Amendment (Budget Measure) Determination 2019.

(2)  This instrument may also be cited as PB 56 of 2019.

2  Commencement

(1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 October 2019.	1 October 2019

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

This instrument is made under subsection 99(4) of the National Health Act 1953.

4  Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Pharmaceutical benefits supplied by private hospitals) Determination 2010

1  After section 4

Insert:

4A  Application and transitional arrangements

Schedule 1 sets out application and transitional arrangements in relation to amendments of this instrument.

2  Section 5

Insert:

brand has the same meaning as in Part VII of the Act.

determined quantity, of a listed brand of a pharmaceutical item, has the same meaning as in Part VII of the Act.

listed brand has the same meaning as in Part VII of the Act.

maximum quantity, of a brand of a pharmaceutical item, means a quantity or number of units of the pharmaceutical item determined under paragraph 85A(2)(a) of the Act in relation to that brand of pharmaceutical item.

pharmaceutical item has the same meaning as in Part VII of the Act.

3  Section 5 (definition of Regulations)

Omit “1960”, substitute “2017”.

4  Section 5 (definition of storage and handling mark‑up)

Repeal the definition.

5  Subsection 8(1)

Omit “regulation 24”, substitute “section 49”.

6  Sub‑subparagraphs 11(1)(a)(i)(A) and (B)

Repeal the sub‑subparagraphs, substitute:

(A)  the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and

(B)  the storage and handling mark‑up worked out under section 11A for the pack quantity; and

7  Sub‑subparagraphs 11(1)(c)(i)(A) and (B)

Repeal the sub‑subparagraphs, substitute:

(A)  the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and

(B)  the storage and handling mark‑up worked out under section 11A for the pack quantity; and

8  After section 11

Insert:

11A  Storage and handling mark‑up

(1)  For the purposes of sub‑subparagraphs 11(1)(a)(i)(B) and (c)(i)(B) and paragraph (b) of step 1 in section 14, the storage and handling mark‑up for a pack quantity of a ready‑prepared pharmaceutical benefit is worked out in accordance with this section.

(2)  Work out the relevant quantity for the pack quantity, and the ex‑manufacturer price for the relevant quantity, using the following method statement.

Method statement

Step 1.   Identify the approved ex‑manufacturer price (the AEMP) or the proportional ex‑manufacturer price (the PEMP) (as applicable) for the pack quantity.

Step 2.   Identify any maximum quantities and any determined quantities of each listed brand of the pharmaceutical item concerned (other than any maximum quantity that relates to a supply of any of those brands that can only be made in accordance with special arrangements under section 100 of the Act).

Step 3.   From the quantities identified in step 2, identify the relevant quantity for the pack quantity, which is:

(a)     the maximum quantity (if any) that is the highest whole number multiple of the pack quantity, or, if there is no such maximum quantity, the determined quantity (if any) that is the highest whole number multiple of the pack quantity; or

(b)     if paragraph (a) does not apply—the maximum quantity (if any) that is the closest to the pack quantity or, if 2 maximum quantities are equally close, the greater of those maximum quantities; or

(c)     if paragraph (a) does not apply and there are no maximum quantities—the determined quantity (if any) that is the closest to the pack quantity or, if 2 determined quantities are equally close, the greater of those determined quantities.

Step 4.   The ex‑manufacturer price for the relevant quantity is the relevant quantity multiplied by the AEMP or PEMP (as applicable) for the pack quantity.

(3)  If the ex‑manufacturer price for the relevant quantity is $930.06 or less, the storage and handling mark‑up for the pack quantity is 7.52% of the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity.

(4)  If:

(a)  the ex‑manufacturer price for the relevant quantity is more than $930.06; and

(b)  the relevant quantity and the pack quantity are the same;

the storage and handling mark‑up for the pack quantity is $69.94.

(5)  If:

(a)  the ex‑manufacturer price for the relevant quantity of the brand of the pharmaceutical item is more than $930.06; and

(b)  the relevant quantity and the pack quantity are not the same;

the storage and handling mark‑up for the pack quantity is worked out using the following formula:

9  Section 14 (method statement, step 1, paragraphs (a) to (d))

Repeal the paragraphs, substitute:

(a)  the approved ex‑manufacturer price or the proportional ex‑manufacturer price (as applicable) for the pack quantity; and

(b)  the storage and handling mark‑up worked out under section 11A for the pack quantity; and

(c)  the mark‑up worked out under section 12.

10  At the end of the instrument

Add:

Schedule 1—Application and transitional arrangements

Note:       See section 4A.

Part 1—Amendments made by the National Health (Pharmaceutical benefits supplied by private hospitals) Amendment (Budget Measure) Determination 2019

1  Application of amendments

  The amendments of this instrument by items 4 and 6 to 9 of Schedule 1 to the National Health (Pharmaceutical benefits supplied by private hospitals) Amendment (Budget Measure) Determination 2019 apply in relation to the supply of a pharmaceutical benefit on or after 1 October 2019.