National Health Act 1953

The Pharmaceutical Benefits Advisory Committee shall make recommendations to the Minister from time to time as to the drugs and medicinal preparations which it considers should be made available as pharmaceutical benefits under this Part and shall advise the Minister upon any other matter concerning the operation of this Part referred to it by the Minister.

The Pharmaceutical Benefits Advisory Committee must make recommendations to the Minister from time to time about what should be specified in a determination under subsection 84AAA(2).

Subsection (3AA) does not limit subsection (3).

For the purpose of deciding whether to recommend to the Minister that a drug or medicinal preparation, or a class of drugs and medicinal preparations, be made available as pharmaceutical benefits under this Part, the Committee shall give consideration to the effectiveness and cost of therapy involving the use of the drug, preparation or class, including by comparing the effectiveness and cost of that therapy with that of alternative therapies, whether or not involving the use of other drugs or preparations.

Without limiting the generality of subsection (3A), where therapy involving the use of a particular drug or medicinal preparation, or a class of drugs and medicinal preparations, is substantially more costly than an alternative therapy or alternative therapies, whether or not involving the use of other drugs or preparations, the Committee:

shall not recommend to the Minister that the drug, preparation or class be made available as pharmaceutical benefits under this Part unless the Committee is satisfied that the first‑mentioned therapy, for some patients, provides a significant improvement in efficacy or reduction of toxicity over the alternative therapy or therapies; and

if the Committee does recommend to the Minister that the drug, preparation or class be made available as pharmaceutical benefits under this Part, the Committee shall include in its recommendation a statement that the Committee is satisfied as mentioned in paragraph (a).

If the Committee is of the opinion that a drug or medicinal preparation should be made available as a pharmaceutical benefit under this Part, the Committee must, in its recommendation under subsection (3), specify whether the drug or medicinal preparation and another drug or medicinal preparation should be treated as interchangeable on an individual patient basis.

Where the Committee is of the opinion that a drug or medicinal preparation, or a class of drugs and medicinal preparations, should be made available as pharmaceutical benefits under this Part, but only in certain circumstances, the Committee shall, in its recommendation under subsection (3), specify those circumstances.

A drug or medicinal preparation shall not be declared, pursuant to paragraph 85(2)(a), to be a drug or medicinal preparation in relation to which this Part applies unless:

the drug or medicinal preparation was, immediately before the commencement of this subsection, a pharmaceutical benefit; or

the Committee has recommended to the Minister that it be so declared.

A class of drugs or medicinal preparations, or of drugs and medicinal preparations, shall not be declared, pursuant to paragraph 85(2)(a), to be a class of drugs or medicinal preparations, or of drugs and medicinal preparations, in relation to which this Part applies unless:

each member of that class was, immediately before the commencement of this subsection, a pharmaceutical benefit; or

the Committee has recommended to the Minister that the class be so declared.

The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation.

If:

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

on and after the day the revocation or variation comes into force, the drug or medicinal preparation would cease to be a listed drug;

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.

The Pharmaceutical Benefits Advisory Committee may give advice to the Minister as to which PBS prescribers should be authorised to write prescriptions for the supply of a pharmaceutical benefit.

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 only be supplied under one or more of the prescriber bag provisions.

The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2AA) in relation to a drug or medicinal preparation.

If:

under subsection (4AACB), the Minister proposes to revoke or vary a declaration under subsection 85(2AA) declaring that a drug or medicinal preparation (the drug) can only be supplied under one or more of the prescriber bag provisions; and

on and after the day the revocation or variation comes into force, the drug could be supplied under this Part otherwise than under one or more of the prescriber bag provisions;

the Minister also revokes or varies the declaration under 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

the Pharmaceutical Benefits Advisory Committee recommends against the Minister taking the action in paragraph (c).

The Pharmaceutical Benefits Advisory Committee may give advice to the Minister in relation to whether or not the Minister should determine that a brand of a pharmaceutical item is to be treated as equivalent to one or more other brands of pharmaceutical items.

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.

The Minister may, by legislative instrument, revoke or vary a declaration under subsection 85(2A) in relation to a drug or medicinal preparation.

If:

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

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;

the Minister also revokes or varies the declaration under 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

the Pharmaceutical Benefits Advisory Committee recommends against the Minister taking the action in paragraph (c).

If the Committee is of the opinion that the Minister should, or should not, determine a therapeutic group, the Committee must advise the Minister accordingly.

If the Committee is of the opinion that the following circumstances exist in relation to a pharmaceutical item:

the listed drug in the pharmaceutical item represents suitable therapy for a particular patient population;

the pharmaceutical item is suitable for use by a particular subgroup of that population because of either or both of the form and manner of administration of the drug in the item;

no other pharmaceutical item that has that drug is suitable for use by that subgroup because of either or both of the form and manner of administration of the drug in that other item;

If the Committee is satisfied that therapy involving a combination item provides, for some patients:

a significant improvement in patient compliance with the therapy; or

a significant improvement in efficacy or reduction in toxicity;

The Pharmaceutical Benefits Advisory Committee may give advice to the Minister in relation to whether the Minister should determine that a brand of a pharmaceutical item is not a new brand for the purposes of section 99ACB or 99ACD.

The Pharmaceutical Benefits Advisory Committee must:

make recommendations to the Minister from time to time about the vaccines it considers should be designated vaccines (see section 9B); and

advise the Minister about any other matter concerning the operation of section 9B referred to it by the Minister.

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.

If immunisation involving the use of a particular vaccine (the first vaccine) is substantially more costly than an alternative vaccine:

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

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).

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

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.

The regulations may make provision for and in relation to the procedure of the Committee.