National Health Act 1953 - Determination under subsection 84HA (1) (08/11/2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L04426 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

  NATIONAL HEALTH ACT 1953

DETERMINATION UNDER SUBSECTION 84HA (1)

Part VII of the National Health Act 1953 (the Act) regulates the Pharmaceutical Benefits Scheme (PBS), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits. One of the benefits available through the Veterans’ Entitlements Act 1986 for eligible veterans is the Repatriation Pharmaceutical Benefits Scheme (RPBS).

Division 1A of Part VII of the Act provides for a “safety net scheme in relation to pharmaceutical benefits and repatriation pharmaceutical benefits (as defined in section 84 of the Act).  The safety net scheme is designed to provide financial protection for those patients and their families who require a large number of PBS or RPBS medicines.

At the person’s request, a pharmacist records the supply of PBS and RPBS medicines to that person and the cost of the supply.  When a person reaches a certain spending level on PBS or RPBS medicines (the safety net threshold), that person may be eligible for a safety net concession card or a pharmaceutical benefits entitlement card in respect of a relevant entitlement period. The issuing of such a card to a person enables that person to receive PBS or RPBS medicines at a reduced rate or free of charge for the remainder of the relevant entitlement period.  The relevant entitlement period for the safety net scheme is a calendar year, that is, from 1 January to 31 December.

Section 84C of the Act provides for eligibility for a person to receive a safety net concession card, and for a person to receive a pharmaceutical benefits entitlement card.

Section 84DA of the Act provides for the issue of a safety net concession card on application by a person, and sets out the manner in which such applications may be made.

Section 84E of the Act provides for the issue of a pharmaceutical benefits entitlement card on application by a person, and sets out the manner in which such applications may be made.

Applications under sections 84DA and 84E of the Act may be made to:

  • the Secretary of the Department of Health and Ageing;
  • a pharmacist approved under the Act;
  • a medical practitioner approved under the Act;
  • a hospital authority approved under the Act; or
  • a public hospital authority.

Section 84H of the Act provides that additional or replacement concession cards and entitlement cards may be issued in accordance with the National Health (Pharmaceutical Benefits) Regulations 1960, in specified circumstances, including:

  • where a person’s concession card or entitlement card has been lost, stolen, damaged or destroyed; and
  • where members of a nominated family change after being issued with a concession card or entitlement card.

The National Health (Pharmaceutical Benefits) Regulations 1960 require, among other things, applications for additional or replacement concession cards and entitlement cards to be made to the same person who issued the original card.

Subsection 84HA (1) of the Act provides that an approved pharmacist, an approved medical practitioner or an approved hospital authority who issues a concession card or entitlement card (or an additional or replacement concession card or entitlement card) is entitled to be paid a fee by the Commonwealth. The fee for issuing the card is determined by the Minister.  Subsection 84HA (2) of the Act provides that the Minister may not determine this fee without the written agreement of the Pharmacy Guild of Australia.  The Pharmacy Guild of Australia has been consulted on this matter and has agreed, in writing, to the making of this determination.

This fee is intended as a payment to an approved pharmacist, an approved medical practitioner or an approved hospital authority for the duties associated with issuing a safety net concession card or pharmaceutical benefits entitlement card, or an additional or replacement concession card or entitlement card. 

The previous determination in respect of this matter ceases to have effect at the end of 31 December 2007. This determination will commence on 1 January 2008.  Details of the determination are set out in the Attachment.

The determination is a legislative instrument for the purpose of the Legislative Instruments Act 2003.


ATTACHMENT

Paragraph 1 provides that the determination commences on 1 January 2008.

Paragraph 2 provides that the fee payable for issuing each safety net concession card, or pharmaceutical benefits entitlement card, or each additional or replacement concession card or entitlement card, is $7.86.

This fee is only payable if the card has been issued:

  • by an approved pharmacist, approved medical practitioner or approved hospital authority within the meaning of section 84 of the National Health Act 1953: and
  • in accordance with the provisions of Division 1A of Part VII of the National Health Act 1953, and the matters prescribed in Parts IIAA and IIA of the National Health (Pharmaceutical Benefits) Regulations 1960.

Overview

The National Health Act 1953 was enacted to provide for the regulation and administration of the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS). One of its key objectives is to establish a safety net scheme to offer financial protection to patients and their families who require a substantial amount of PBS or RPBS medicines. The Act aims to ensure that individuals who reach a certain threshold of spending on these medicines can apply for a safety net concession card or a pharmaceutical benefits entitlement card, enabling them to receive medicines at a reduced rate or free of charge for the remainder of the calendar year. The safety net scheme is managed under Division 1A of Part VII of the Act, with various provisions detailing eligibility, application processes, and the issuance of concession and entitlement cards. The National Health (Pharmaceutical Benefits) Regulations 1960 further supports this scheme by outlining the conditions under which additional or replacement cards may be issued. This legislative framework was designed to address the gap in financial support for patients with high pharmaceutical needs, ensuring they receive the necessary medications without incurring excessive costs.

Scope and Application

The National Health Act 1953, specifically under Division 1A of Part VII, regulates the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS) which are designed to provide financial relief for eligible individuals who require a significant number of PBS or RPBS medicines. The Act applies to any person who has reached the safety net threshold for spending on PBS or RPBS medicines and seeks to provide financial protection by issuing concession cards or entitlement cards that allow for reduced or free pharmaceutical benefits for the remainder of the calendar year. The scheme operates nationally within Australia and applies to any approved pharmacists, medical practitioners, or hospital authorities that issue these cards on behalf of the Commonwealth. The Act stipulates that the issuing of such cards can be done by the Secretary of the Department of Health and Ageing or by other approved professionals, and it provides for the payment of a fee to these entities for their services in issuing the cards. The Act also allows for additional or replacement cards to be issued under specified circumstances, as outlined in the National Health (Pharmaceutical Benefits) Regulations 1960. The payment of the fee to the card-issuing entities is contingent upon written agreement from the Pharmacy Guild of Australia, which has already concurred with the specified fee for the issuance of these cards.

Key Provisions

The legislation, F2007L04426, pertains to a determination under subsection 84HA(1) of the National Health Act 1953, specifically regarding the fee payable for issuing safety net concession cards, pharmaceutical benefits entitlement cards, and their replacements. Under section 84C, individuals eligible for these cards may apply, as detailed in sections 84DA and 84E, to entities such as the Secretary of the Department of Health and Ageing, approved pharmacists, medical practitioners, or hospital authorities. Applications for replacement or additional cards, outlined in section 84H, must be made to the original issuer of the card. The determination, effective from 1 January 2008, sets the fee at $7.86 for each card issued by an approved entity in compliance with the Act and associated regulations. The Act imposes certain obligations on the parties involved. Approved pharmacists, medical practitioners, and hospital authorities are mandated to record the supply of PBS and RPBS medicines and the associated costs upon request. These entities must also issue safety net concession cards and pharmaceutical benefits entitlement cards to eligible individuals, as per sections 84DA and 84E. The Act further requires these entities to apply for written agreement from the Pharmacy Guild of Australia before the Minister can determine the fee payable for issuing these cards, as stipulated in subsection 84HA(2). Furthermore, entities must ensure that applications for replacement or additional cards are handled in accordance with the National Health (Pharmaceutical Benefits) Regulations 1960. Any breach of the provisions outlined in the National Health Act 1953 and its regulations may result in civil or criminal consequences. For instance, failure to issue the appropriate cards to eligible individuals, or the incorrect recording of pharmaceutical supplies, could be considered non-compliance with the Act. Penalties for such breaches are not explicitly detailed in the provided text, but they may be found in other sections of the Act or in related regulations. The determination itself does not specify penalties but establishes the fee structure for card issuance, ensuring that approved entities are compensated appropriately for their duties under the Act.

Legal classification tags

Area of Law
Health Law
Pharmaceutical Law
Instrument
Legislative Instrument
Concepts
Fees & Charges
Licensing & Registration
Compliance Obligations

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.