National Health Act 1953

Benefits shall be provided by the Commonwealth, in accordance with this Part, in respect of pharmaceutical benefits.

While most pharmaceutical benefits are generally available for supply under this Part, some pharmaceutical benefits (see sections 85AAA and 85AA) can only be supplied under this Part under the prescriber bag provisions or in accordance with special arrangements under section 100.

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)).

The drugs and medicinal preparations in relation to which this Part applies are:

drugs and medicinal preparations that are:

declared by the Minister, by legislative instrument, to be drugs and medicinal preparations to which this Part applies; or

included in a class of drugs and medicinal preparations declared by the Minister, by legislative instrument, to be a class of drugs and medicinal preparations to which this Part applies; and

medicinal preparations composed of:

one or more of the drugs and medicinal preparations referred to in paragraph (a), being a drug or medicinal preparation that is, or drugs and medicinal preparations that are, included in a class of drugs and medicinal preparations declared by the Minister, by legislative instrument, to be a class of drugs and medicinal preparations to which this paragraph applies; and

one or more of such additives as are declared by the Minister, by legislative instrument, to be additives to which this paragraph applies.

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)).

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)).

If:

the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and

the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AACA) that the drug be supplied only under one or more of the prescriber bag provisions;

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(4AACC).

If:

the Minister makes a declaration under subsection (2) in relation to a drug or medicinal preparation (the drug); and

the Pharmaceutical Benefits Advisory Committee has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100;

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).

The Minister may, by legislative instrument, determine, by reference to strength, type of unit, size of unit or otherwise, the form or forms of a listed drug.

A form of a listed drug as determined by the Minister under subsection (3) may be such as to require the addition of a substance or substances to the drug so that it will be suitable for administration in a particular manner or at a particular strength.

The Minister may, by legislative instrument, determine the manner of administration of a form of a listed drug, being a form of the drug in relation to which a determination under subsection (3) is in force.

The Minister may, by legislative instrument, determine a brand of a pharmaceutical item.

If the Minister determines a brand of a pharmaceutical item under subsection (6), the Minister may, by legislative instrument, determine that, for the purposes of paragraph 103(2A)(b), the brand is to be treated as equivalent to one or more other brands of pharmaceutical items.

In deciding whether the brand of pharmaceutical item is to be treated as equivalent to one or more other brands of pharmaceutical items, the Minister must have regard to any advice given by the Pharmaceutical Benefits Advisory Committee.

If, on 1 November 2015, the Schedule of Pharmaceutical Benefits specifies that a brand of a pharmaceutical item is equivalent to one or more other brands of pharmaceutical items, the specification is taken to have been made following a determination to that effect under subsection (6A).

The Minister may, by legislative instrument, determine:

that a particular pharmaceutical benefit is to be a relevant pharmaceutical benefit for the purposes of section 88A; and

the circumstances in which a prescription for the supply of the pharmaceutical benefit may be written.

The Minister may, by legislative instrument, determine that a particular pharmaceutical benefit can only be supplied under one or more of the prescriber bag provisions.

The Minister may, by legislative instrument, determine that:

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

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.

If:

a listed brand of a pharmaceutical item (the listed brand) has a drug; and

another brand of the pharmaceutical item, or a brand of another pharmaceutical item, is biosimilar or bioequivalent to the listed brand;

Subsection (9) does not affect the separate declarations of the following drugs made under subsection (2) before the commencement of this subsection:

epoetin lambda;

epoetin alfa.

The Minister may, by notifiable instrument, determine that, for the purposes of this Part:

more than one name is recognised for the same listed drug; or

more than one description is recognised for the same form of a listed drug; or

more than one description is recognised for the same manner of administration of a form of a listed drug.

Without limiting subsection (11), the Minister may determine a name or description as being used during a period of time, such as before or after a specified date.