Commonwealth Consolidated Acts

NATIONAL HEALTH ACT 1953 - SECT 140

    The Governor - General may make regulations, not inconsistent with this Act, prescribing all matters which by this Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to this Act, and, in particular, for prescribing:

  (a)   the fees and allowances payable to members of a committee established under this Act, other than members who are officers of the Public Service of the Commonwealth or of a State; and

  (b)   penalties not exceeding a fine of 20 penalty units for offences against the regulations.

This Division is about price reductions for listed brands of pharmaceutical items.

Subdivision B requires there to be a price reduction for the first new brand of a pharmaceutical item (other than a combination item) when the brand lists. The listing of the new brand of the pharmaceutical item also provides an automatic trigger for price reductions to occur under Subdivision E (see sections   99ACQ and 99ACR).

Subdivision C requires there to be a price reduction for the first new brand of a pharmaceutical item that is a combination item when the brand lists. The listing of the new brand of the pharmaceutical item also provides an automatic trigger for price reductions to occur under Subdivision E (see sections   99ACQ and 99ACR).

Subdivision D provides for other price reductions for pharmaceutical items. These price reductions include reductions that occur on a certain anniversary of the drug in the pharmaceutical item being a listed drug.

Subdivision E provides for price reductions that are automatically triggered when Subdivision B or C applies to require a first new brand price reduction for a brand of a pharmaceutical item.

Price reductions for listed brands of pharmaceutical items under this Division are subject to:

(a)   determinations made by the Minister to not apply, or reduce, the price reduction; or

(b)   price reductions made under Subdivision E of Division   3B (see section   99ACG).

This Division requires the responsible person for certain brands of pharmaceutical items to comply with the price disclosure requirements for each supply of those brands of pharmaceutical items.

•   Subdivision B has the price disclosure requirements. It provides for regulations to set out the kind of information that is required to be provided for the brand of the pharmaceutical item, the form and manner in which that information is to be provided and when that information is to be provided.

•   The price disclosure requirements generally apply in relation to brands of pharmaceutical items that have a drug on F2.

•   Subdivision D provides for the consequences of failing to comply with the price disclosure requirements.

In addition, this Division reduces the approved ex - manufacturer price of the brand of the pharmaceutical item in specified circumstances (see Subdivision E). This reduction happens as a result of the price being adjusted based on information collected about brands of pharmaceutical items.

This Division is about guaranteeing the supply of certain brands of pharmaceutical items.

Subdivision B requires the responsible person for certain brands of pharmaceutical items to supply those brands of pharmaceutical items during a specified period.

Subdivision C sets out which brands of pharmaceutical items are required to be supplied, and the period in which they are required to be supplied.

Subdivision D provides for when the responsible person is considered to have failed to supply, or been unable to supply, the brand of the pharmaceutical item.

Subdivision E requires the responsible person to notify the Minister if the person will fail or be unable to supply, or has failed or been unable to supply, the brand of the pharmaceutical item.

Subdivision F sets out the possible consequences for the responsible person if the person fails, or is unable, to supply the brand of the pharmaceutical item.

Subdivision G sets out the possible consequences for other brands of pharmaceutical items that were affected by the brand of the pharmaceutical item, if the brand of the pharmaceutical item is delisted under Subdivision F.

This Division enables fees to be charged for certain services provided by the Commonwealth in order to recover the cost to the Commonwealth of providing those services. Those services relate to the exercise of certain powers of the Minister under this Act.

Subdivision B provides for regulations to set out the fees that are payable for those services, as well as other matters relating to the payment of those fees and the provision of those services (including some consequences of failing to pay a fee).

Subdivision C sets out another possible consequence of failing to pay a fee by providing for the Minister to refuse to exercise certain powers until the fee is paid.

Subdivision D provides that the Minister must cause a review to be undertaken of the impact of cost - recovery measures provided for under this Division and any regulations made under this Division, and must table an annual report on related processes.