NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS SCHEME) BILL 2010

i National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Contents

1 Short

title

...........................................................................................

2 Commencement

.................................................................................

3 Schedule(s)

........................................................................................

Schedule 1--Increasing the 12.5% price reduction to 16%

National Health Act 1953

Schedule 2--One-off 2%, 5% and 25% price reductions

National Health Act 1953

Schedule 3--Merging of Part A and Part T of F2

National Health Act 1953

Schedule 4--Price disclosure

National Health Act 1953

Schedule 5--Under co-payment data

National Health Act 1953

Schedule 6--Special arrangements

Part 1--Main amendments

National Health Act 1953

Part 2--Consequential amendments

Health Insurance Act 1973

Medicare Australia Act 1973

Part 3--Application and transitional provisions

Schedule 7--Miscellaneous

National Health Act 1953

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010 1

A Bill for an Act to amend the National Health Act

1953, and for related purposes

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the National Health Amendment

(Pharmaceutical Benefits Scheme) Act 2010.

2 Commencement

(1) Each provision of this Act 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.

2 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Commencement information

Column 1

Column 2

Column 3

Provision(s)

Commencement

Date/Details

1. Sections 1 to 3

and anything in

this Act not

elsewhere covered

by this table

The day this Act receives the Royal

Assent.

2. Schedule 1

1 February 2011.

1 February 2011

3. Schedules 2, 3

and 4

1 October 2010.

1 October 2010

4. Schedule 5

1 April 2012.

1 April 2012

5. Schedules 6

and 7

1 October 2010.

1 October 2010

Note:

This table relates only to the provisions of this Act as originally

passed by both Houses of the Parliament and assented to. It will not be

expanded to deal with provisions inserted in this Act after assent.

(2) Column 3 of the table contains additional information that is not

part of this Act. Information in this column may be added to or

edited in any published version of this Act.

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.

Increasing the 12.5% price reduction to 16% Schedule 1

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Schedule 1--Increasing the 12.5% price

reduction to 16%

National Health Act 1953

1 Subsection 84(1)

Insert:

subject to a 12.5% price reduction: see subsection 99ACA(2).

2 Subsection 84(1)

Insert:

subject to a 16% price reduction: see subsection 99ACA(2A).

3 Section 99AC

Omit "12.5%" (wherever occurring), substitute "16%".

4 Paragraph 99ACA(2)(a)

After "applied", insert "before 1 February 2011".

5 After subsection 99ACA(2)

Insert:

(2A) A listed component drug contained in a drug in a combination item

has been subject to a 16% price reduction if:

(a) any of the following has applied to a brand of a

pharmaceutical item that has the listed component drug and

has the same manner of administration as the combination

item:

(i)

section

99ACB;

(ii) subsection 99ACF(1) or (2) because of item 1 of the

table in section 99ACF; or

(b) a pharmaceutical item that has the listed component drug and

has the same manner of administration as the combination

item is in a class of pharmaceutical items to which a 16%

administrative price reduction has applied.

6 Subdivision B of Division 3A of Part VII (heading)

Schedule 1 Increasing the 12.5% price reduction to 16%

4 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Repeal the heading, substitute:

Subdivision B--16% price reductions for new brands of

pharmaceutical items that are not combination items

7 Paragraphs 99ACB(2)(a) to (c)

After "12.5%", insert "or 16%".

Note 1: The heading to section 99ACB is altered by omitting "12.5%" and substituting "16%".

Note 2: The heading to subsection 99ACB(4) is altered by omitting "12.5%" and substituting

"16%".

8 Subsection 99ACB(5)

Omit "12.5%", substitute "16%".

9 Paragraphs 99ACD(1A)(a) to (c)

After "12.5%", insert "or 16%".

Note 1: The heading to section 99ACD is altered by omitting "12.5%" and substituting "16%".

Note 2: The heading to subsection 99ACD(4) is altered by omitting "12.5%" and substituting

"16%".

10 Subsection 99ACD(5)

After "(6)", insert ", (6A), (6B)".

11 Subsection 99ACD(5)

Omit "12.5%", substitute "16%".

12 Subsection 99ACD(6)

Repeal the subsection, substitute:

Adjustment for prior price reductions to component drugs

(6) If, on a day before the determination day:

(a) one or more of the listed component drugs (the component)

contained in the drug in the existing item had been subject to

one of the following (the prior price reduction of the

component):

(i) a 12.5% price reduction;

(ii) a 16% price reduction; and

Increasing the 12.5% price reduction to 16% Schedule 1

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

(b) because of the prior price reduction of the component, the

approved price to pharmacists of the existing brand of the

existing item was reduced;

then the reduction referred to in subsection (5) is to be adjusted to

reflect:

reduction of the component that was taken into account in

working out the amount of the reduction to the approved

price to pharmacists of the existing brand of the existing

item; and

(d) the quantity of the component contained in the drug in the

existing item.

(6A) For the purposes of subsection (6), if:

(a) the prior price reduction of the component was a 12.5% price

reduction; and

(b) the flowed-on percentage was 100%;

then the reduction referred to in subsection (5) is to be adjusted so

that there is no further reduction in relation to the component.

(6B) For the purposes of subsection (6), if:

(a) the prior price reduction of the component was a 12.5% price

reduction; and

(b) the flowed-on percentage was less than 100%;

then the reduction referred to in subsection (5) is to be adjusted so

that the percentage worked out as follows is taken into account in

relation to the component:

12.5%

Flowed-on percentage

12.5%

�

13 Subparagraph 99ACE(3)(a)(ii)

Repeal the subparagraph, substitute:

(ii) subject to subsections (5), (5A) and (5B), does not

exceed the agreed price in force, on the day before that

day, for the related brand of the related item, reduced by

16%; or

Note 1: The heading to section 99ACE is altered by omitting "12.5%" and substituting "16%".

Note 2: The heading to subsection 99ACE(2) is altered by omitting "12.5%" and substituting

"16%".

Schedule 1 Increasing the 12.5% price reduction to 16%

6 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

14 Subparagraph 99ACE(3)(b)(ii)

Repeal the subparagraph, substitute:

(ii) subject to subsections (5), (5A) and (5B), does not

exceed the agreed price in force, on the day before that

day, for the related brand of the related item, reduced by

16%.

15 Subparagraph 99ACE(4)(a)(ii)

Repeal the subparagraph, substitute:

(ii) subject to subsections (5), (5A) and (5B), do not exceed

those respective prices in force on the day before that

day, reduced by 16%; or

16 Subparagraph 99ACE(4)(b)(ii)

Repeal the subparagraph, substitute:

(ii) subject to subsections (5), (5A) and (5B), does not

exceed the determined price in force, on the day before

that day, for the related brand, reduced by 16%.

17 Subsection 99ACE(5)

Repeal the subsection, substitute:

Adjustment for prior price reductions to component drugs

(5) If, on a day before the reduction day:

(a) one or more of the listed component drugs (the component)

contained in the related item had been subject to one of the

following (the prior price reduction of the component):

(i) a 12.5% price reduction;

(ii) a 16% price reduction; and

(b) because of the prior price reduction of the component, the

approved price to pharmacists of the related brand of the

related item.

(5A) For the purposes of subsection (5), if:

(a) the prior price reduction of the component was a 12.5% price

reduction; and

(b) the flowed-on percentage was 100%;

then the reduction referred to in subsection (3) or (4) is to be

adjusted so that there is no further reduction in relation to the

component.

(5B) For the purposes of subsection (5), if:

(a) the prior price reduction of the component was a 12.5% price

reduction; and

(b) the flowed-on percentage was less than 100%;

then the reduction referred to in subsection (3) or (4) is to be

adjusted so that the percentage worked out as follows is taken into

account in relation to the component:

12.5%

Flowed-on percentage

12.5%

�

18 Subsection 99ACF(1) (table item 1)

Omit "12.5%", substitute "16%".

Note 1: The heading to section 99ACG is altered by inserting "or 16%" after "12.5%".

Note 2: The heading to section 99ACH is altered by omitting "12.5%" and substituting "16%".

Schedule 2 One-off 2%, 5% and 25% price reductions

8 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Schedule 2--One-off 2%, 5% and 25% price

reductions

National Health Act 1953

1 Subsection 84(1)

Insert:

relevant price: see subsection 99ACF(5).

2 Subsection 84(1)

Insert:

subject to an outstanding staged reduction: see subsection

99ACA(1).

3 Section 99AC

Repeal the section, substitute:

99AC What this Division is about

This Division is about price reductions for listed brands of

pharmaceutical items.

Subdivision B requires there to be at least a 12.5% price reduction

in the price of a new brand of a pharmaceutical item (other than a

combination item) when it lists. The listing of the new brand of the

pharmaceutical item also provides a trigger for price reductions to

occur under Subdivision D (see section 99ACH) for:

(a) other existing brands of the pharmaceutical item; and

(b) existing brands of pharmaceutical items that have the same

drug and manner of administration; and

same therapeutic group and the same manner of

administration.

One-off 2%, 5% and 25% price reductions Schedule 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Subdivision C sets out the circumstances in which price reductions

are required for combination items.

Subdivision CA sets out the circumstances in which price

reductions are required for new brands of pharmaceutical items

that have the same drug as an existing brand of a pharmaceutical

item that is subject to an outstanding staged reduction under

section 99ACK. The listing of the new brand or brands also

provides a trigger for price reductions to occur under Subdivision

D (see sections 99ACM and 99ACN) for existing brands of

pharmaceutical items that have that drug.

Subdivision D provides for other price reductions for

pharmaceutical items (including for combination items in some

cases). These price reductions:

(a) are triggered when Subdivision B applies to require a 12.5%

price reduction to a new brand of a pharmaceutical item; or

(b) are triggered when Subdivision CA applies to a new brand of

a pharmaceutical item that has the same drug as an existing

brand of a pharmaceutical item that is subject to an

outstanding staged reduction; or

particular day.

4 Subsection 99ACA(1)

Insert:

relevant price: see subsection 99ACF(5).

5 Subsection 99ACA(1)

Insert:

subject to an outstanding staged reduction: a brand of a

pharmaceutical item is subject to an outstanding staged reduction

on a day if:

(a) on any day before that day, section 99ACK had applied to the

brand of the pharmaceutical item; and

Schedule 2 One-off 2%, 5% and 25% price reductions

10 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

(b) on the day before that day, the agreed price, or the

determined price and claimed price, of the brand of the

pharmaceutical item had not been reduced, because of the

application of section 99ACF in relation to section 99ACK or

99ACM, by 25% of the relevant price of the brand of the

pharmaceutical item.

6 After Subdivision C of Division 3A of Part VII

Insert:

Subdivision CA--New brands of pharmaceutical items having

drugs with outstanding staged reductions

99ACEA Price reduction for new brand of pharmaceutical item

having drug with outstanding staged reductions--new

brand bioequivalent or biosimilar to existing listed brand

When this section applies

(1) Subject to subsection (2), this section applies to a brand (the new

brand) of a pharmaceutical item (the trigger item) on a day (the

reduction day) if:

(a) on the reduction day, a determination under subsection 85(6)

comes into force in relation to the new brand of the trigger

item; and

(b) on the day before the reduction day:

(i) the new brand of the trigger item was not a listed brand

of the trigger item; and

(ii) a brand (the existing brand) of a pharmaceutical item

(the existing item) was a listed brand of the existing

item; and

biosimilar to the existing brand of the existing item; and

(d) the trigger item and existing item have the same drug and

manner of administration; and

(e) on the reduction day, either or both of the following are

subject to an outstanding staged reduction:

(i) the existing brand of the existing item;

One-off 2%, 5% and 25% price reductions Schedule 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

(ii) a brand (the related brand) of a pharmaceutical item

(the related item) that has the same drug as the existing

item and the trigger item.

Note 1:

For the purposes of this subsection, the new brand and the existing

brand may be the same brand, or the trigger item and the existing item

may be the same pharmaceutical item.

Note 2:

For the purposes of this subsection, the new brand and the related

brand may be the same brand, or the trigger item and the related item

may be the same pharmaceutical item.

Note 3:

For the purposes of this subsection, the existing brand and related

brand may be the same brand, or the existing item and related item

may be the same pharmaceutical item.

When this section does not apply

(2) This section does not apply if, before the reduction day, this

section applied to:

(a) the new brand, or another listed brand, of the trigger item; or

(b) a listed brand of another pharmaceutical item that has the

same drug as the new brand of the trigger item.

Note:

Subsection (1) is taken not to have applied in relation to a brand of a

pharmaceutical item in some cases: see section 99AEI.

Price reduction

(3)

The

Minister:

(a) may, under section 85AD, make a price agreement for the

new brand of the trigger item; and

(b) must not make a determination under section 85B in relation

to the new brand of the trigger item.

(4) Subject to subsection (5), the agreed price for the new brand of the

trigger item that comes into force on the reduction day must not

exceed the approved price to pharmacists, on the day before the

reduction day, of the existing brand of the existing item, reduced

by the same amount that the agreed price or determined 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.

Apportioning if quantities are different

(5)

If:

Schedule 2 One-off 2%, 5% and 25% price reductions

12 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

(a) the approved price to pharmacists, on the day before the

reduction day, of the existing brand of the existing item is for

a particular quantity or number of units of that item; and

(b) the agreed price for the new brand of the trigger item is not

for the same quantity or number of units;

then, for the purposes of subsection (3), the approved price to

pharmacists of the existing brand of the existing item is taken to be

adjusted proportionally to what it would have been if the quantity

or number of units of the existing brand of the existing item had

been the same as the quantity or number of units of the new brand

of the trigger item.

This section does not limit Minister's powers

(6) This section does not limit the Minister's powers, after the

reduction day, to make:

(a) further price agreements; or

(b) determinations under section 85B;

for the new brand of the trigger item.

99ACEB New brands of pharmaceutical items having drug with

outstanding staged reductions----new brands not

bioequivalent or biosimilar to existing listed brand

When this section applies

(1) Subject to subsection (2), if:

(a) on a day (the reduction day), a determination under

subsection 85(6) comes into force in relation to 2 or more

brands (the new brands) of pharmaceutical items (the trigger

items); and

(b) the new brands of the trigger items:

(i) are bioequivalent or biosimilar; and

(ii) have the same drug and manner of administration; and

trigger items were not listed brands of the trigger items; and

(d) on the day before the reduction day, there was not a listed

brand of a pharmaceutical item that:

(i) is bioequivalent or biosimilar to the new brands of the

trigger items; and

One-off 2%, 5% and 25% price reductions Schedule 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

(ii) has the same drug and manner of administration as the

new brands of the trigger items; and

(e) on the reduction day, a listed brand (the existing brand) of a

pharmaceutical item (the existing item):

(i) has the same drug as the trigger items; and

(ii) is subject to an outstanding staged reduction;

then this section applies to the new brands of the trigger items.

Note 1:

For the purposes of this subsection, the new brands may be the same

brand, or the trigger items may be the same pharmaceutical item.

Note 2:

For the purposes of this subsection, any of the new brands and the

existing brand may be the same brand, or any of the trigger items and

the existing item may be the same pharmaceutical item.

When this section does not apply

(2) This section does not apply if, before the reduction day, this

section applied to:

(a) the new brands, or another listed brand, of the trigger items;

(b) a listed brand of another pharmaceutical item that has the

same drug as the new brands of the trigger items.

Note:

Subsection (1) is taken not to have applied in relation to a brand of a

pharmaceutical item in some cases: see section 99AEI.

Price reduction

(3)

The

Minister:

(a) may, under section 85AD, make a price agreement for the

new brands of the trigger items; and

(b) must not make a determination under section 85B in relation

to the new brands of the trigger items.

This section does not limit Minister's powers

(4) This section does not limit the Minister's powers, after the

reduction day, to make:

(a) further price agreements; or

(b) determinations under section 85B;

for the new brands of the trigger items.

7 Subsection 99ACF(1)

Schedule 2 One-off 2%, 5% and 25% price reductions

14 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Omit "by the following:", substitute "by the percentage or amount

specified in column 3 of the table for the section referred to in column

2.".

8 Paragraphs 99ACF(1)(d) and (e)

Repeal the paragraphs.

9 Subsection 99ACF(1) (after table item 2)

Insert:

2A 99ACIA

10 Subsection 99ACF(1) (table item 4)

Repeal the item, substitute:

99ACK

the amount that equals the staged

percentage, on the reduction day, of

the relevant price for the brand of

the pharmaceutical item

99ACL

the reduction percentage specified in

subsection 99ACL(2)

99ACM

the amount that equals the

outstanding staged percentage, on

the reduction day, of the relevant

price for the brand of the

pharmaceutical item

99ACN

the reduction percentage specified in

subsection 99ACN(2)

8 99ACO

99ACP

the reduction amount specified in

subsection 99ACP(2)

99ACQ

the reduction percentage specified in

subsection 99ACQ(2)

11 Subsection 99ACF(5)

Repeal the subsection, substitute:

(5) In this section:

outstanding staged percentage for a listed brand of a

pharmaceutical item on a reduction day, means 25% less each

staged percentage that has applied under item 4 of the table in

One-off 2%, 5% and 25% price reductions Schedule 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

subsection (1) to the brand of the pharmaceutical item on a day

before the reduction day.

relevant price of a listed brand of a pharmaceutical item means:

(a) for the agreed price or determined price--the amount that

was the agreed price or determined price in force in relation

to the brand of the pharmaceutical item on 31 July 2008; and

(b) for the claimed price--the amount that was the claimed price

in force in relation to the brand of the pharmaceutical item on

the day before the reduction day.

staged percentage on a reduction day for a listed brand of a

pharmaceutical item, means the percentage that is prescribed for

the purposes of paragraph 99ACK(3)(b) for the reduction day.

12 After subsection 99ACG(1)

Insert:

2% reduction on 1 February 2011 does not apply if a 12.5%

reduction has applied

(1A)

If:

(a) on 1 December 2010, a 12.5% administrative price reduction

or any of the following applies to a listed brand of a

pharmaceutical item:

(i)

section

99ACB;

(ii) section 99ACD or 99ACE;

(iii) subsection 99ACF(1) or (2) because of item 1 of the

table in section 99ACF; and

(b) apart from this subsection, item 2A of the table would apply

in relation to the brand of the pharmaceutical item, or another

listed brand of the pharmaceutical item, on 1 February 2011;

then item 2A of the table does not apply on 1 February 2011 in

relation to the brand of the pharmaceutical item or the other brand

of the pharmaceutical item.

Note:

The heading to subsection 99ACG(1) is replaced by the heading "2% reduction on

1 August 2008, 2009 or 2010 does not apply if a 12.5% reduction has applied".

13 Subparagraph 99ACG(2)(b)(iii)

Repeal the subparagraph, substitute:

Schedule 2 One-off 2%, 5% and 25% price reductions

16 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

(iii) subsection 99ACF(1) or (2) because of any item (other

than item 4, 5, 6 or 7) of the table in section 99ACF;

Note 1: The heading to subsection 99ACG(2) is replaced by the heading "Other price

reductions do not apply if a price disclosure reduction has applied".

Note 2: The heading to section 99ACI is altered by adding at the end "on 1 August 2008, 2009

and 2010".

14 After section 99ACI

Insert:

99ACIA 2% statutory price reduction on 1 February 2011

If:

(a) on 31 January 2011, a price agreement or a determination

under section 85B is in force in relation to a listed brand of a

pharmaceutical item; and

(b) on 30 September 2010, the drug in the pharmaceutical item

was in Part A of F2; and

exempt item;

then this section applies to the listed brand of the pharmaceutical

item on 1 February 2011.

15 Subsection 99ACK(1)

Omit "This section", substitute "Subject to subsection (1A), this

section".

Note:

The heading to section 99ACK is altered by omitting "phased" and substituting

"staged".

16 After subsection 99ACK(1)

Insert:

(1A) This section does not apply to a brand of a pharmaceutical item on

a reduction day if, on that day, section 99ACM applies or had

previously applied to the brand of the pharmaceutical item.

17 At the end of Subdivision D of Division 3A of Part VII

Add:

One-off 2%, 5% and 25% price reductions Schedule 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

99ACL Staged price reduction: staged reductions under

section 99ACK causing statutory price reductions for

other brands of pharmaceutical items having the drug

(1) This section applies to a listed brand (the existing brand) of a

pharmaceutical item (the existing item) on a day (the reduction

day) if, on the reduction day:

(a) the existing brand of the existing item is not subject to an

outstanding staged reduction; and

(b) a listed brand (the staged brand) of a pharmaceutical item

(the staged item) is subject to an outstanding staged

reduction; and

item; and

(d) the existing item and the staged item have the same drug.

Note:

For the purposes of paragraphs (b) and (d), the existing brand and the

staged brand may be the same brand, or the existing item and the

staged item may be the same pharmaceutical item.

(2) For the purposes of item 5 of the table in section 99ACF, the

reduction percentage for the existing brand of the existing item is

the percentage that is worked out as follows:

Method statement

Step 1. See column 3 of item 4 of the table in section 99ACF to

work out the amount (the staged brand's reduction

amount) by which the agreed price or determined price

of the staged brand of the staged item is reduced on the

reduction day.

Step 2. Work out what percentage the staged brand's reduction

amount represents of the agreed price or determined price

of the staged brand of the staged item on the day before

the reduction day.

The reduction percentage is the percentage worked out at step 2.

Schedule 2 One-off 2%, 5% and 25% price reductions

18 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

99ACM Staged price reduction: new brand listing bringing forward

outstanding staged reductions

This section applies to a listed brand (the staged brand) of a

pharmaceutical item (the staged item) on a day (the reduction day)

if, on the reduction day:

(a) the staged brand of the staged item is subject to an

outstanding staged reduction; and

(b) section 99ACEA or 99ACEB applies to a brand (the new

brand) of a pharmaceutical item (the trigger item); and

Note:

For the purposes of paragraphs (b) and (c), the staged brand and the

new brand may be the same brand, or the staged item and the trigger

item may be the same pharmaceutical item.

99ACN Staged price reduction: bringing forward outstanding

staged reductions causing statutory price reduction for

other brands of pharmaceutical items having the drug

(1) This section applies to a listed brand (the existing brand) of a

pharmaceutical item (the existing item) on a day (the reduction

day) if, on the reduction day:

(a) the existing brand of the existing item is not subject to an

outstanding staged reduction; and

(b) section 99ACM applies to a listed brand (the staged brand)

of a pharmaceutical item (the staged item) on the reduction

day; and

Note:

For the purposes of paragraphs (b) and (c), the existing brand and the

staged brand may be the same brand, or the existing item and the

staged item may be the same pharmaceutical item.

(2) For the purposes of item 7 of the table in section 99ACF, the

reduction percentage for the existing brand of the existing item is

the percentage that is worked out as follows:

Method statement

Step 1. See column 3 of item 6 of the table in section 99ACF to

work out the amount (the staged brand's reduction

amount) by which the agreed price or determined price

One-off 2%, 5% and 25% price reductions Schedule 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

of the staged brand of the staged item is reduced on the

reduction day.

Step 2. Work out what percentage the staged brand's reduction

amount represents of the agreed price or determined price

of the staged brand of the staged item on the day before

the reduction day.

The reduction percentage is the percentage worked out at step 2.

99ACO 5% statutory price reduction for brands of pharmaceutical

items having a drug that is not subject to outstanding

staged reductions

If:

(a) on 31 January 2011, a price agreement or a determination

under section 85B is in force in relation to a listed brand (the

relevant brand) of a pharmaceutical item (the relevant item);

and

(b) on 30 September 2010, the drug in the relevant item was in

Part T of F2; and

and

(d) on 1 February 2011, the relevant brand of the relevant item is

not subject to an outstanding staged reduction; and

(e) on 1 February 2011, there is not another listed brand of a

pharmaceutical item that:

(i) is subject to an outstanding staged reduction; and

(ii) has the same drug as the relevant item;

then this section applies to the relevant brand of the relevant item

on 1 February 2011.

99ACP 5% statutory price reduction for brands of pharmaceutical

items subject to outstanding staged reductions

(1)

If:

(a) on 31 January 2011, a price agreement or a determination

under section 85B is in force in relation to a listed brand (the

relevant brand) of a pharmaceutical item (the relevant item);

and

Schedule 2 One-off 2%, 5% and 25% price reductions

20 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

(b) on 30 September 2010, the drug in the relevant item was in

Part T of F2; and

and

(d) on 1 February 2011, the relevant brand of the relevant item is

subject to an outstanding staged reduction;

then this section applies to the relevant brand of the relevant item

on 1 February 2011.

(2) For the purposes of item 9 of the table in section 99ACF, the

reduction amount for the relevant brand of the relevant item is the

amount that is worked out as follows:

Method statement

Step 1. Work out the relevant price of the relevant brand of the

relevant item.

Step 2. Work out the amount (the comparison amount) that

equals 25% of the relevant price.

Step 3. Subtract the comparison amount from the relevant price.

The reduction amount is 5% of the amount worked out at step 3.

99ACQ 5% statutory price reduction for brands of pharmaceutical

items having a drug that is subject to outstanding staged

reductions

(1)

If:

(a) on 31 January 2011, a price agreement or a determination

under section 85B is in force in relation to a listed brand (the

relevant brand) of a pharmaceutical item (the relevant item);

and

(b) on 30 September 2010, the drug in the relevant item was in

Part T of F2; and

and

(d) on 1 February 2011, the relevant brand of the relevant item is

not subject to an outstanding staged reduction; and

One-off 2%, 5% and 25% price reductions Schedule 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

(e) on 1 February 2011:

(i) another listed brand (the staged brand) of a

pharmaceutical item (the staged item) is subject to an

outstanding staged reduction; and

(ii) the relevant item and the staged item have the same

drug;

then this section applies to the relevant brand of the relevant item

on 1 February 2011.

(2) For the purposes of item 10 of the table in section 99ACF, the

reduction percentage for the relevant brand of the relevant item is

the percentage that is worked out as follows:

Method statement

Step 1. See column 3 of item 9 of the table in section 99ACF to

work out the amount (the staged brand's reduction

amount) by which the agreed price or determined price

of the staged brand of the staged item is reduced on the

reduction day.

Step 2. Work out what percentage the staged brand's reduction

amount represents of the agreed price or determined price

of the staged brand of the staged item on the day before

the reduction day.

The reduction percentage is the percentage worked out at step 2.

18 After paragraph 99AEI(2)(d)

Insert:

(da) the new brand of the trigger item referred to in

section 99ACEA; or

(db) one of the new brands of the triggers items referred to in

section 99ACEB; or

19 At the end of subsection 99AEI(3)

Add:

; or (c) if subsection 99ACEA(1) applied to the delisted brand of the

existing item--for the purposes of subsection 99ACEA(2),

Schedule 2 One-off 2%, 5% and 25% price reductions

22 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

subsection 99ACEA(1) is taken not to have applied to the

delisted brand of the existing item; or

(d) if subsection 99ACEB(1) applied to the delisted brand of the

existing item--for the purposes of subsection 99ACEB(2),

subsection 99ACEB(1) is taken not to have applied to the

delisted brand of the existing item.

Merging of Part A and Part T of F2 Schedule 3

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Schedule 3--Merging of Part A and Part T of

National Health Act 1953

1 At the end of section 84AD

Add:

(6) Regulations made for subsection (2) or (4) cease to be in force on

1 October 2010.

(7) Regulations made for subsection (5), to the extent that they

prescribe that a drug is in Part A or Part T of F2, cease to be in

force on 1 October 2010.

Note:

Subsection (7) does not affect the regulations to the extent that they

prescribe that a drug is on F1 or F2.

2 Subsection 85AC(5)

Omit "1 January 2011", substitute "1 October 2010".

Schedule 4 Price disclosure

24 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Schedule 4--Price disclosure

National Health Act 1953

1 Section 99AD

Omit:

�

Subdivision C sets out the situations when the responsible

person for the brand of the pharmaceutical item is required to

comply with the price disclosure requirements. This could be

because compliance with the price disclosure requirements is

mandatory, or because the responsible person volunteers to

comply with them.

Substitute:

�

The price disclosure requirements generally apply in relation

to brands of pharmaceutical items that have a drug on F2.

2 Section 99ADA

Repeal the section, substitute:

99ADA Division does not apply to exempt items

This Division does not apply to brands of exempt items.

3 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:

(a) on 1 April 2012--the amount worked out in accordance with

section 99ADJ, if that section so provides; or

(b) otherwise--the amount equal to the amount of the weighted

average disclosed price of the brand of the pharmaceutical

item.

4 Subsection 99ADB(1)

Price disclosure Schedule 4

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Insert:

agreed quantity, for a brand of a pharmaceutical item, is the

quantity or number of units of the pharmaceutical item by

reference to which the appropriate maximum price for sales of the

brand of the pharmaceutical item to approved pharmacists has

been:

(a) agreed under section 85AD; or

(b) determined under subsection 85B(2).

5 Subsection 99ADB(1)

Insert:

applicable approved ex-manufacturer price of a brand of a

pharmaceutical item is the approved ex-manufacturer price of the

brand on the last day of the period in respect of which the weighted

average disclosed price of the brand of the pharmaceutical item is

determined.

6 Subsection 99ADB(1)

Insert:

unadjusted price reduction for a brand of a pharmaceutical item is

the difference between:

(a) the applicable approved ex-manufacturer price of the brand

of the pharmaceutical item; and

(b) the weighted average disclosed price of the brand of the

pharmaceutical item;

expressed as a percentage of that applicable approved

ex-manufacturer price.

7 Subsection 99ADB(1) (definition of weighted average

disclosed price)

Omit "or (5)".

8 Subsection 99ADB(5)

Repeal the subsection.

9 Subsection 99ADB(6)

Omit "or (5)".

Schedule 4 Price disclosure

26 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

10 At the end of section 99ADB

Add:

(7) A determination made under subsection (4) in relation to a brand of

a pharmaceutical item may include:

(a) the adjusted approved ex-manufacturer price of the brand of

the pharmaceutical item; and

(b) the adjusted approved price to pharmacists of the brand of

the pharmaceutical item.

11 Subdivision C of Division 3B of Part VII (heading)

Repeal the heading.

12 Sections 99ADD and 99ADE

Repeal the sections, substitute:

99ADD When the price disclosure requirements apply

The responsible person for a listed brand of a pharmaceutical item

that has a drug on F2 is required to comply with the price

disclosure requirements for each supply of the brand of the

pharmaceutical item.

13 After paragraph 99ADH(1)(a)

Insert:

(aa) the Minister, by legislative instrument, determines a day (the

reduction day) for the purposes of this section in relation to

the brand of the pharmaceutical item; and

14 Paragraph 99ADH(1)(b)

After "pharmaceutical item", insert "on the reduction day".

15 Paragraphs 99ADH(1)(c) and (d)

Repeal the paragraphs, substitute:

pharmaceutical item is at least 10%.

16 Subsection 99ADH(2)

Repeal the subsection, substitute:

Price disclosure Schedule 4

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

(2) For the purposes of paragraph 99ADH(1)(aa), the reduction day

must be a prescribed day.

17 Subsection 99ADH (6)

Repeal the subsection.

18 At the end of Division 3B of Part VII

Add:

99ADJ Minimum average 23% price reduction for some brands of

pharmaceutical items

(1)

If:

(a) this section applies to a brand of a pharmaceutical item; and

(b) the average unadjusted price reduction, worked out under

subsection (3), for all the brands of pharmaceutical items to

which this section applies is less than 23%;

the adjusted approved ex-manufacturer price of the brand of the

pharmaceutical item, on 1 April 2012, is the amount worked out

under subsection (6).

Brands of pharmaceutical items to which this section applies

(2) This section applies to a brand of a pharmaceutical item (the

relevant brand) if:

(a) the drug in the pharmaceutical item is on F2 on 1 October

2010; and

(b) no requirement to comply with price disclosure requirements

has arisen under former subsection 99ADD(1) before

1 October 2010 in relation to:

(i) the relevant brand; or

(ii) any other brand of any pharmaceutical item having that

drug and having the same manner of administration as

the relevant brand.

The average unadjusted price reduction

(3)

The

average unadjusted price reduction for all the brands of

pharmaceutical items to which this section applies is the

percentage worked out as follows:

Schedule 4 Price disclosure

28 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Method statement

Step 1. For each brand of a pharmaceutical item to which this

section applies, multiply:

(a)

the applicable approved ex-manufacturer price of

the brand; by

(b)

the total number of the supplies of the agreed

quantity for the brand that were supplies in respect

of which the Commonwealth provided benefits

under section 85, during the period of 12 months

starting on 1 October 2010.

Step 2. For each amount worked out under step 1, work out the

amount of that step 1 amount that represents a percentage

equal to the unadjusted price reduction for the brand.

Step 3. Divide:

(a)

the sum of all the amounts worked out under step 2

for all of the brands of pharmaceutical items to

which this section applies; by

(b)

the sum of all the amounts worked out under step 1

for all of those brands.

Step 4. The amount worked out under step 3, multiplied by 100

and expressed as a percentage, is the average unadjusted

price reduction for all the brands of pharmaceutical items

to which this section applies.

(4) For the purposes only of subsection (3), if:

(a) a combination item has a drug to which subsection 85AB(5)

applies; and

(b) there is only one listed brand (the single brand) of the

combination item; and

component drug) that the drug referred to in paragraph (a)

contains; and

(d) a brand of the pharmaceutical item (a related brand):

Price disclosure Schedule 4

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

(i) is a brand to which this section applies; and

(ii) has the same manner of administration as the single

brand;

then:

(e) the single brand is taken to be a brand of a pharmaceutical

item to which this section applies; and

(f) subject to subsection (5), the unadjusted price reduction for

the single brand is taken to be the percentage by which the

approved ex-manufacturer price of the single brand would be

reduced if the approved price to pharmacists of the brand

were to be reduced under section 99ACC to take account of:

(i) the unadjusted price reduction for the related brand

being applied to the component drug; and

(ii) in a case where the single brand contains one or more

other component drugs in relation to which there are

one or more other related brands of pharmaceutical

items--the unadjusted price reductions for the other

related brands being applied to the other component

drugs.

(5) The unadjusted price reduction for the single brand is taken to be

0% if the single brand is a brand of a combination item in relation

to which the Pharmaceutical Benefits Advisory Committee has

advised the Minister under subsection 101(4AC).

Working out the adjusted approved ex-manufacturer price

(6) If subsection (1) applies in relation to a brand of a pharmaceutical

item, the adjusted approved ex-manufacturer price of the brand is

worked out as follows:

Method statement

Step 1. Divide 23% by the average unadjusted price reduction,

worked out under subsection (3), for all the brands of

pharmaceutical items to which this section applies. The

result is the guaranteed adjustment proportion.

Step 2. For each of those brands of pharmaceutical items,

multiply the guaranteed adjustment proportion by the

Schedule 4 Price disclosure

30 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

unadjusted price reduction for the brand of the

pharmaceutical item.

Step 3. For each of those brands, reduce the applicable approved

ex-manufacturer price of the brand by the percentage

worked out under step 2.

Step 4. If the lowest price disclosed, in compliance with price

disclosure requirements under section 99ADD, for the

pharmaceutical item during the period of 12 months

starting on 1 October 2010, is higher than the amount

worked out under step 3, work out the difference

between:

(a)

the applicable approved ex-manufacturer price of

the brand; and

(b)

that lowest price;

expressed as a percentage of that applicable approved

ex-manufacturer price.

Step 5. The GAP-adjusted reduction for the brand is:

(a)

unless step 4 applies--the percentage worked out

under step 2; or

(b)

if step 4 applies--the percentage worked out under

step 4.

Step 6. Work out, under subsection (3), the average unadjusted

price reduction for all the brands of pharmaceutical items

to which this section applies, as if the unadjusted price

reduction for each brand were the GAP-adjusted

reduction for the brand.

Step 7. If the average unadjusted price reduction worked out

under step 6 is at least 23%, reduce the applicable

approved ex-manufacturer price of the brand by a

percentage of that price equal to the GAP-adjusted

reduction for the brand. The result is the GAP-adjusted

approved ex-manufacturer price of the brand.

Price disclosure Schedule 4

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Step 8. If step 7 applies, the adjusted approved ex-manufacturer

price of a brand to which this section applies is the

GAP-adjusted approved ex-manufacturer price of the

brand.

Step 9. If the average unadjusted price reduction worked out

under step 6 is less than 23%, repeat steps 1 to 6, as many

times as necessary until step 7 is satisfied, as if:

(a)

the reference in step 1 to the average unadjusted

price reduction were a reference to the average

unadjusted price reduction last worked out under

step 6; and

(b)

the reference in step 2 to the unadjusted price

reduction for a brand of a pharmaceutical item

were a reference to the GAP-adjusted reduction for

the brand last worked out under step 5.

(7) However, if, in applying or repeating steps 1 to 6 of the method

statement in subsection (6), step 4 of the method statement applies

in relation to all the brands of pharmaceutical items to which this

section applies:

(a) steps 6 to 9 of the method statement cease to apply; and

(b)

the

adjusted approved ex-manufacturer price of a brand to

which this section applies is worked out by reducing the

applicable approved ex-manufacturer price of the brand by a

percentage of that price equal to the GAP-adjusted reduction

for the brand last worked out under step 5 of the method

statement.

Effect of the unadjusted price reduction for a brand being less than

10%

(8) If, but for this subsection, the unadjusted price reduction for a

brand of a pharmaceutical item would be less than 10%, the

unadjusted price reduction for the brand is taken to be 0% for the

purposes of:

(a) working out under subsection (3) the average unadjusted

price reduction for all the brands of pharmaceutical items to

which this section applies; and

Schedule 4 Price disclosure

32 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

(b) working out under subsection (6) the adjusted approved

ex-manufacturer price of the brand.

The weighted average disclosed price of a brand

(9) Until the Minister determines the weighted average disclosed price

of a brand of a pharmaceutical item in respect of the period of 12

months ending on 30 September 2011, that weighted average

disclosed price is taken, for the purposes of any reference in this

section to:

(a) the applicable approved ex-manufacturer price of the brand;

(b) the unadjusted price reduction for the brand;

to be the price worked out in accordance with the regulations made

for the purposes of subsection 99ADB(6).

19 Section 99AEL

Repeal the section.

20 Application provision

(1)

The amendments made by items 2, 12 and 19 of this Schedule apply in

relation to supplies of brands of pharmaceutical items occurring on or

after the commencement of this item.

(2)

The amendments made by items 7 to 9 and 13 to 17 of this Schedule

apply if the period in respect of which the weighted average disclosed

price of the relevant brand of the relevant pharmaceutical item is

determined ends on or after the commencement of this item.

Under co-payment data Schedule 5

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Schedule 5--Under co-payment data

National Health Act 1953

1 At the end of Division 2 of Part VII

Add:

98AC Information about supplies

(1) An approved supplier that supplies a pharmaceutical benefit

(including a supply taken, because of subsection 99(2A), to be a

supply otherwise than under this Part):

(a) must give to the Secretary, in relation to the supply of that

benefit, the information specified in rules made by the

Minister under paragraph (4)(a); and

(b) must give the information in accordance with the rules made

by the Minister under paragraph (4)(b).

(2) Subsection (1) does not apply if the approved supplier makes, or

proposes to make, a claim for payment in relation to the supply of

the pharmaceutical benefit under section 99AAA.

(3) Subject to the rules made by the Minister under paragraph (4)(b),

subsections 99AAA(4) and (5) and section 99AAB (about the

procedures for giving information) apply in relation to the giving

of information under this section in the same way as they apply in

relation to the giving of information under section 99AAA.

(4) The Minister must, by legislative instrument, make:

(a) rules specifying the information to be given to the Secretary

by approved suppliers in relation to the supply by them of

pharmaceutical benefits; and

(b) rules defining the procedures to be followed by approved

suppliers in giving information to the Secretary in relation to

the supply by them of pharmaceutical benefits.

(5) In making rules for the purposes of paragraph (4)(b), the Minister

may define different procedures:

(a) for the giving of information by electronic means; and

Schedule 5 Under co-payment data

34 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

(b) for the giving of information otherwise than by electronic

means.

(6) Rules made under this section may be set out in the same document

as rules made under subsection 99AAA(8).

2 Subsection 99AAA(8)

Omit "instrument in writing", substitute "legislative instrument".

3 Subsection 99AAA(9)

Repeal the subsection.

4 Paragraph 135AA(1)(c)

Repeal the paragraph, substitute:

connection with:

(i) a claim for payment of a benefit under the Medicare

Benefits Program or the Pharmaceutical Benefits

Program; or

(ii) a supply of a pharmaceutical benefit to which

subsection 98AC(1) applies.

5 Subparagraph 135AA(2)(a)(i)

After "made", insert ", or who provided the pharmaceutical benefit".

6 Subparagraph 135AA(2)(a)(ii)

After "goods", insert "or the pharmaceutical benefit".

7 After subsection 135AA(5A)

Insert:

(5B) Nothing in this section, or in the guidelines issued by the Privacy

Commissioner, precludes the inclusion, in a database of

information:

(a) held by the Medicare Australia CEO; and

(b) relating to supplies of pharmaceutical benefits to which

subsection 98AC(1) applies;

of the pharmaceutical entitlements number applicable to the person

to whom each such supply relates:

Schedule 6 Special arrangements

Part 1 Main amendments

36 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Schedule 6--Special arrangements

Part 1--Main amendments

National Health Act 1953

1 Subsection 84(1)

Insert:

pharmaceutical benefit has a drug: see subsection 84ABA(3).

2 Subsection 84(1) (definition of special pharmaceutical

product)

Repeal the definition.

3 At the end of section 84ABA

Add:

(3) A reference in this Part to a pharmaceutical benefit having a drug is

a reference to the pharmaceutical benefit having the drug or

medicinal preparation referred to in paragraph (a) of the definition

of pharmaceutical benefit in subsection 84(1) in relation to the

pharmaceutical benefit.

Note:

The heading to section 84ABA is altered by omitting "or combination items" and

substituting ", combination items or pharmaceutical benefits".

4 Subsection 85(1) (note)

Repeal the note, substitute:

Note 1:

While most pharmaceutical benefits are generally available for supply

under this Part, some pharmaceutical benefits (see section 85AA) can

only be supplied under this Part in accordance with special

arrangements under section 100.

Note 2:

Special arrangements under section 100 can modify the effect of this

Part in relation to the supply of pharmaceutical benefits that are

covered by the arrangements (see subsection 100(3)).

Note:

The following heading to subsection 85(1) is inserted "Pharmaceutical benefits".

5 At the end of subsection 85(2)

Add:

Special arrangements Schedule 6

Main amendments Part 1

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Note 1:

The Minister cannot make a declaration under this subsection in

relation to a drug or medicinal preparation unless the Pharmaceutical

Benefits Advisory Committee has recommended that the drug or

medicinal preparation be declared (see subsections 101(4) and (4A)).

Note 2:

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 so as to delist the drug or medicinal preparation

without first obtaining the Pharmaceutical Benefits Advisory

Committee's advice (see subsection 101(4AAB)).

Note:

The following heading to subsection 85(2) is inserted "Drugs etc.".

6 Subsection 85(2A)

Repeal the subsection, substitute:

Drugs etc. that can only be supplied under special arrangements

(2A)

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(4AAD) that the drug be

made available only under special arrangements under

section 100;

then the Minister must, by legislative instrument, declare that the

drug can only be supplied under such special arrangements.

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(4AAF).

7 Subsections 85(2AA), (2AB) and (2AC)

Repeal the subsections.

Note 1: The following heading to subsection 85(3) is inserted "Forms".

Note 2: The following heading to subsection 85(5) is inserted "Manners of administration".

Note 3: The following heading to subsection 85(6) is inserted "Brands".

8 At the end of section 85

Add:

Prescriptions of pharmaceutical benefits in certain circumstances

(7) The Minister may, by legislative instrument, determine:

Schedule 6 Special arrangements

Part 1 Main amendments

38 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

(a) that a particular pharmaceutical benefit is to be a relevant

pharmaceutical benefit for the purposes of section 88A; and

(b) the circumstances in which a prescription for the supply of

the pharmaceutical benefit may be written.

Pharmaceutical benefits that can only be supplied under special

arrangements

(8) The Minister may, by legislative instrument, determine that:

(a) a particular pharmaceutical benefit (other than a

pharmaceutical benefit that has a drug covered by

subsection (2A)) can only be supplied under special

arrangements under section 100; or

(b) one or more of the circumstances in which a prescription for

the supply of a pharmaceutical benefit may be written under

paragraph (7)(b) are circumstances in which the benefit can

only be supplied under special arrangements under

section 100.

9 After section 85

Insert:

85AA Pharmaceutical benefits that can only be supplied under

special arrangements

(1) If the Minister makes a declaration under subsection 85(2A) in

relation to a drug or medicinal preparation (the drug), then every

pharmaceutical benefit that has that drug can only be supplied

under this Part in accordance with special arrangements under

section 100.

(2) If the Minister makes a determination under paragraph 85(8)(a) in

relation to a pharmaceutical benefit, then that pharmaceutical

benefit can only be supplied under this Part in accordance with

special arrangements under section 100.

(3) If the Minister makes a determination under paragraph 85(8)(b)

about the circumstances in which a pharmaceutical benefit can

only be supplied under special arrangements under section 100,

then, in those circumstances, the pharmaceutical benefit can only

be supplied under this Part in accordance with those arrangements.

Special arrangements Schedule 6

Main amendments Part 1

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

10 Section 88A

Omit "85(2A)" (wherever occurring), substitute "85(7)".

11 Subsection 100(1)

Omit "providing that an adequate supply of special pharmaceutical

products", substitute ", or in relation to, providing that an adequate

supply of pharmaceutical benefits".

12 Paragraph 100(1)(b)

Repeal the paragraph, substitute:

(b) who are receiving treatment in circumstances in which

pharmaceutical benefits (other than those to which

subsection (1A) applies) are inadequate for that treatment; or

can be more conveniently or efficiently supplied under the

arrangements.

13 After subsection 100(1)

Insert:

(1A) This subsection applies to:

(a) pharmaceutical benefits to which subsection 85AA(1) or (2)

applies; and

(b) pharmaceutical benefits supplied in the circumstances

referred to in subsection 85AA(3).

14 Subsection 100(3)

Omit "This Part has", substitute "This Part, and regulations or other

instruments made for the purposes of this Part, have".

15 Section 100AA

Repeal the section.

16 Subsections 101(3) and (3A)

Omit "or special pharmaceutical products".

17 Paragraphs 101(3B)(a) and (b)

Omit "or special pharmaceutical products".

Schedule 6 Special arrangements

Part 1 Main amendments

40 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

18 Subsection 101(3C)

Omit "or special pharmaceutical products".

Note:

The following heading to subsection 101(4) is inserted "Functions relating to

declarations under subsection 85(2)".

19 After subsection 101(4A)

Insert:

(4AAA) The Minister may, by legislative instrument, revoke or vary a

declaration under subsection 85(2) in relation to a drug or

medicinal preparation.

(4AAB)

If:

(a) under subsection (4AAA), the Minister proposes to revoke or

vary a declaration under subsection 85(2) in relation to a drug

or medicinal preparation; and

(b) on and after the day the revocation or variation comes into

force, the drug or medicinal preparation would cease to be a

listed drug;

then, before making the revocation or variation, the Minister must

obtain the advice in writing of the Pharmaceutical Benefits

Advisory Committee in relation to the proposed revocation or

variation.

(4AAC) An advice under subsection (4AAB) must be laid before each

House of the Parliament with the declaration under

subsection (4AAA) to which the advice relates.

Functions relating to declarations under subsection 85(2A)

(4AAD) 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 be made

available only under special arrangements under section 100.

(4AAE) The Minister may, by legislative instrument, revoke or vary a

declaration under subsection 85(2A) in relation to a drug or

medicinal preparation.

(4AAF)

If:

Special arrangements Schedule 6

Main amendments Part 1

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

(a) under subsection (4AAE), the Minister proposes to revoke or

vary a declaration under subsection 85(2A) in relation to a

drug or medicinal preparation (the drug); 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 special arrangements under section 100;

then the Minister can only make the revocation or variation if:

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).

20 Sections 114 and 116

Omit "or special pharmaceutical products".

21 Subsection 133(1)

Omit "or special pharmaceutical products".

22 Subsections 134(1) and (2)

Omit "or special pharmaceutical product".

23 Subsection 135A(5A)

Omit "or special pharmaceutical products may be published in spite of

the fact that the manufacturer of any of those benefits or products",

substitute "may be published in spite of the fact that the manufacturer of

any of those benefits".

24 Subsection 135A(5C)

Omit "or special pharmaceutical product" (wherever occurring).

25 Subsection 135A(8)

Schedule 6 Special arrangements

Part 1 Main amendments

42 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Omit "or special pharmaceutical product shall not be divulged in

pursuance of subsection (6) or (7) in a manner that is likely to enable

the identification of the person to whom that service was rendered, that

treatment or care was provided or that benefit or product", substitute

"must not be divulged in pursuance of subsection (6) or (7) in a manner

that is likely to enable the identification of the person to whom that

service was rendered, that treatment or care was provided or that

benefit".

26 Subsection 135A(24) (definition of special pharmaceutical

product)

Repeal the definition.

27 Subsection 135AA(11) (definition of Pharmaceutical

Benefits Program)

Omit "and special pharmaceutical products".

Special arrangements Schedule 6

Consequential amendments Part 2

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Part 2--Consequential amendments

Health Insurance Act 1973

28 Subsection 81(1) (definition of pharmaceutical benefit)

Repeal the definition, substitute:

pharmaceutical benefit means a pharmaceutical benefit as defined

in Part VII of the National Health Act 1953.

Medicare Australia Act 1973

29 Section 3 (definition of pharmaceutical benefit)

Repeal the definition, substitute:

pharmaceutical benefit means a pharmaceutical benefit as defined

in Part VII of the National Health Act 1953.

Schedule 6 Special arrangements

Part 3 Application and transitional provisions

44 National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. ,

2010

Part 3--Application and transitional provisions

30 Definitions

In this Part:

commencement means the commencement of this Schedule.

main Act means the National Health Act 1953.

31 Application of amendments

The amendments made by this Schedule apply on and after

commencement in relation to:

(a) declarations or determinations that are made on or after

commencement under section 85 of the main Act (including

declarations or determinations that are made in relation to a

drug or medicinal preparation that is covered by special

arrangements that were made before commencement under

section 100 of the main Act); and

(b) special arrangements that are made on or after

commencement under section 100 of the main Act.

32 Transitional provisions relating to legislative instruments

made before commencement

(1)

If the legislative instrument that:

(a) is known as "Instrument Number PB 14 of 2010"; and

(b) was registered on 17 March 2010 under the Federal Register

of Legislative Instruments established under the Legislative

Instruments Act 2003 (registration number F2010L00659);

is in force immediately before commencement, then, on and after

commencement, the drugs and medicinal preparations (the drugs) that

are specified in Schedule 6 to that instrument are to be treated (and may

be dealt with) as if a declaration had been made in relation to the drugs

under subsections 85(2) and (2A) of the main Act.

(2)

If the legislative instrument that:

(a) is known as "Instrument Number PB 41 of 2010"; and

(b) was registered on 30 April 2010 under the Federal Register

of Legislative Instruments established under the Legislative

Instruments Act 2003 (registration number F2010L01083);

Special arrangements Schedule 6

Application and transitional provisions Part 3

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

is in force immediately before commencement, then, on and after

commencement, the drug or medicinal preparation (the drug) specified

in Schedule 1 to that instrument is to be treated (and may be dealt with)

as if a declaration had been made in relation to the drug under

subsections 85(2) and (2A) of the main Act.

(3)

If a legislative instrument that was made under subsection 85(2A) of the

main Act is in force immediately before commencement, then, on and

after commencement, that legislative instrument is to be treated (and

may be dealt with) as if it had been made under subsection 85(7) of the

main Act.

33 Transitional provisions relating to PBAC advice or

recommendations given before commencement

(1)

If, before commencement, the Minister had obtained the advice of the

Pharmaceutical Benefits Advisory Committee under subsection

85(2AB) of the main Act in relation to a proposed revocation or

variation under subsection 85(2AA) of that Act, then, on and after

commencement, that advice is to be treated (and may be dealt with) as

if:

(a) it had been obtained under subsection 101(4AAB) of that

Act; and

(b) it related to a proposed revocation or variation under

subsection 101(4AAA) of that Act.

(2)

If, before commencement, the Pharmaceutical Benefits Advisory

Committee had recommended under paragraph 100AA(4)(a) of the

main Act that the Minister make a declaration in relation to a drug or

medicinal preparation under subsection 100AA(2) of that Act, then, on

and after commencement, that recommendation is to be treated (and

may be dealt with) as if:

(a) it had been obtained under subsections 101(4) and (4AAD) of

that Act; and

(b) it related to declarations under subsections 85(2) and (2A) of

that Act.

(3)

If, before commencement, the Minister had obtained the advice of the

Pharmaceutical Benefits Advisory Committee under subsection

100AA(5) of the main Act in relation to the revocation or variation of a

declaration under subsection 100AA(2) of that Act, then, on and after

Miscellaneous Schedule 7

National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010 No. , 2010

Schedule 7--Miscellaneous

National Health Act 1953

1 Subsection 85(2)

Omit "Subject to subsection (3), the", substitute "The".

2 Subparagraph 99ACA(2)(a)(ii)

Omit "that section", substitute "section 99ACF".

3 Subparagraph 99ACB(3)(a)(ii)

Omit "that section", substitute "section 99ACF".

4 Subsection 99ACC(6)

Repeal the subsection, substitute:

Subject to statutory price reduction

(6) A listed component drug contained in a drug in a combination item

becomes subject to statutory price reduction if:

(a) section 99ACB, subsection 99ACF(1) or (2) (because of

item 1 in the table in section 99ACF) or section 99ADH has

applied to a listed brand of a pharmaceutical item that:

(i) has the listed component drug; and

(ii) has the same manner of administration as the

combination item; or

(b) subsection 99ACF(1) or (2) (because of any of the items

(other than item 1) in the table in section 99ACF) has applied

to a listed brand of a pharmaceutical item that has the listed

component drug.

5 Subsection 99ACD(1)

Omit "subsections (2) and (3)", substitute "subsections (1A) and (2)".

6 Subparagraph 99ACG(1)(a)(iii)

Omit "that section", substitute "section 99ACF".

Commonwealth of Australia Bills

NATIONAL HEALTH AMENDMENT (PHARMACEUTICAL BENEFITS SCHEME) BILL 2010