Federal Register of Legislation - Australian Government

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Act No. 140 of 2005 as made
An Act to amend the National Health Act 1953, and for other purposes
Administered by: Health
Originating Bill: National Health Amendment (Immunisation Program) Bill 2005
Registered 22 Nov 2005
Date of Assent 18 Nov 2005
Table of contents.

 

 

 

 

 

 

National Health Amendment (Immunisation Program) Act 2005

 

No. 140, 2005

 

 

 

 

 

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

  

  


Contents

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

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

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

Schedule 1—Amendment of the National Health Act 1953                            3

Part 1—Immunisation program                                                                                    3

Part 2—Pharmaceutical Benefits Advisory Committee                                      6

 


 

 

National Health Amendment (Immunisation Program) Act 2005

No. 140, 2005

 

 

 

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

Assented to 18 November 2005

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.

 

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.

18 November 2005

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.

1 January 2006

(see F2005L04086)

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.

1 January 2006

(see F2005L04086)

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.


 

Schedule 1Amendment of the National Health Act 1953

Part 1Immunisation 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;

                     (c)  active ingredient;

                     (d)  strength;

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

             (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

                     (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)”.


 

Part 2Pharmaceutical 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.


 

 

Minister’s second reading speech made in—

House of Representatives on 14 September 2005

Senate on 12 October 2005

(139/05)