Insert:

Insert:

Repeal the section, substitute:

(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during the 60-day period ending immediately before the commencement of this subsection, the vaccine was provided under repealed section 9B of this Act.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 .

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 ".

Add "or (4B)".