NATIONAL HEALTH AMENDMENT (IMMUNISATION PROGRAM) BILL 2005

i National Health Amendment (Immunisation Program) Bill 2005 No. , 2005

Contents

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

Commencement .............................................................................1

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

Schedule 1--Amendment of the National Health Act 1953

Part 1--Immunisation program

Part 2--Pharmaceutical Benefits Advisory Committee

National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 1

A Bill for an Act to amend the National Health Act

1953, and for other purposes

The Parliament of Australia enacts:

1 Short title

This Act may be cited as the National Health Amendment

(Immunisation Program) Act 2005.

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 (Immunisation Program) Bill 2005 No. , 2005

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 on which this Act receives the

Royal Assent.

2. Schedule 1,

Part 1

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not

commence within the period of 6 months

beginning on the day on which this Act

receives the Royal Assent, they commence

on the first day after the end of that period.

3. Schedule 1,

Part 2

A single day to be fixed by Proclamation.

However, if any of the provision(s) do not

commence within the period of 6 months

beginning on the day on which this Act

receives the Royal Assent, they commence

on the first day after the end of that period.

Note:

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

passed by 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repealed as set out in the applicable items in the Schedule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.

Amendment of the National Health Act 1953 Schedule 1

Immunisation program Part 1

National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 3

Schedule 1--Amendment of the National

Health Act 1953

Part 1--Immunisation program

1 Subsection 4(1)

Insert:

designated vaccine has the meaning given by subsection 9B(2).

2 Subsection 4(1)

Insert:

vaccine means a vaccine for the purpose of immunising persons.

3 Section 9B

Repeal the section, substitute:

9B Provision of vaccines

(1) The Minister may provide, or arrange for the provision of,

designated vaccines.

Designated vaccines

(2) The Minister may, by legislative instrument, determine that a

specified vaccine is a designated vaccine for the purposes of this

Act.

Note:

For variation and revocation, see subsection 33(3) of the Acts

Interpretation Act 1901.

(3) A vaccine may be specified by reference to any or all of the

following:

(a) brand;

(b) formulation;

(d) strength;

(e) number and timing of doses in a course of immunisation.

Schedule 1 Amendment of the National Health Act 1953

Part 1 Immunisation program

4 National Health Amendment (Immunisation Program) Bill 2005 No. , 2005

(4) Subsection (3) does not limit the ways in which a vaccine may be

specified.

(5) In addition to specifying a vaccine, a determination under

subsection (2) may specify the circumstances in which the vaccine

may be provided.

(6) If any such circumstances are specified, subsection (1) only

authorises the provision of the vaccine in those circumstances.

(7) A vaccine must not be specified in a determination under

subsection (2) unless:

(a) the Pharmaceutical Benefits Advisory Committee has

recommended to the Minister that the vaccine be a designated

vaccine; or

(b) at any time during the 60-day period ending immediately

before the commencement of this subsection, the vaccine was

provided under repealed section 9B of this Act.

(8) Before:

(a) revoking a determination under subsection (2); or

(b) varying a determination under subsection (2) in such a way

that a vaccine ceases to be a designated vaccine;

the Minister must obtain the written advice of the Pharmaceutical

Benefits Advisory Committee in relation to the proposed

revocation or variation.

(9) An advice under subsection (8) is to be tabled in each House of the

Parliament with the revocation or variation to which the advice

relates.

(10) This section does not limit the vaccine-related powers conferred on

the Minister by the Quarantine Act 1908.

4 After subsection 101(4A)

Insert:

Functions relating to vaccines

(4B) The Pharmaceutical Benefits Advisory Committee must:

(a) make recommendations to the Minister from time to time

about the vaccines it considers should be designated vaccines

(see section 9B); and

Amendment of the National Health Act 1953 Schedule 1

Immunisation program Part 1

National Health Amendment (Immunisation Program) Bill 2005 No. , 2005 5

(b) advise the Minister about any other matter concerning the

operation of section 9B referred to it by the Minister.

(4C) For the purpose of deciding whether to recommend to the Minister

that a vaccine be a designated vaccine, the Committee must give

consideration to the effectiveness and cost of immunisation

involving the use of the vaccine, including by comparing the

effectiveness and cost of immunisation involving the use of the

vaccine with the effectiveness and cost of alternative options,

whether or not involving the use of other vaccines.

(4D) If immunisation involving the use of a particular vaccine (the first

vaccine) is substantially more costly than an alternative vaccine:

(a) the Committee must not recommend to the Minister that the

first vaccine be a designated vaccine unless the Committee is

satisfied that the first vaccine, for some individuals, provides

a significant improvement in efficacy or reduction of toxicity

over the alternative vaccine; and

(b) if the Committee recommends to the Minister that the first

vaccine be a designated vaccine--the Committee must

include in its recommendation a statement that the

Committee is satisfied as mentioned in paragraph (a).

(4E) Subsection (4D) does not limit subsection (4C).

(4F) If the Committee is of the opinion that a vaccine should be a

designated vaccine, but should only be provided under subsection

9B(1) in certain circumstances, the Committee must, in its

recommendation under subsection (4B), specify those

circumstances.

Note 1: The following heading to subsection 101(3) is inserted "Functions relating to drugs and

medicinal preparations".

Note 2: The following heading to subsection 101(5) is inserted "Procedure".

5 At the end of paragraph 101A(1)(b)

Add "or (4B)".

Schedule 1 Amendment of the National Health Act 1953

Part 2 Pharmaceutical Benefits Advisory Committee

6 National Health Amendment (Immunisation Program) Bill 2005 No. , 2005

Part 2--Pharmaceutical Benefits Advisory

Committee

6 Subsection 100A(2)

Omit "15", substitute "17".

7 After subsection 100A(5)

Insert:

(5A) The Chairperson holds office on a full-time basis.

8 Subsection 100A(6)

After "Committee", insert "(other than the Chairperson)".

9 Transition to full-time office--Chairperson of the

Pharmaceutical Benefits Advisory Committee

(1)

This item applies to a person who was the Chairperson of the

Pharmaceutical Benefits Advisory Committee immediately before the

commencement of this item.

(2)

After the commencement of this item, the person is taken to hold office

as Chairperson of the Pharmaceutical Benefits Advisory Committee on

a full-time basis.

(3)

Subitem (2) does not prevent the person from ceasing to hold that

office.

Commonwealth of Australia Bills

NATIONAL HEALTH AMENDMENT (IMMUNISATION PROGRAM) BILL 2005