National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1)

Administered by Department of Health, Disability and Ageing

Legislation au F1998B00391 Regulations Not in force Legislative Instrument

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National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1) 1998 No. 374

EXPLANATORY STATEMENT

STATUTORY RULES 1998 NO. 374

Issued by Authority of the Minister for Health and Aged Care

National Health Act 1953

National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1)

Section 140 of the National Health Act 1953 ("'the Act") provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act.

Paragraph 105(b) of the Act provides that the regulations may make provision for or in relation to the writing of prescriptions.

The National Health (Pharmaceutical Benefits) Regulations have been amended to allow for the introduction of new style prescription forms; and to allow the supply of a pharmaceutical benefit up to and including the first anniversary of the date on which the prescription was written.

The prescription form currently on issue comprises a two-part no-carbon required form. The original of the form is signed as a receipt by the patient or agent at the time of first supply of the pharmaceutical benefit and is used by the approved pharmacist in making a claim for payment. The carbon copy (preprinted with the word "Duplicate") is successively attached to any deferred supply authorisation or repeat authorisations until the last occasion of supply of the benefit, when it is retained by the approved pharmacist.

The quality of the carbon copies can deteriorate over time and thus they can become difficult to read. To enhance patient safety, new forms are to be introduced whereby the above functions are reversed - the original (to be preprinted with "pharmacist/patient copy") will circulate with any allowable repeats and be retained by the approved pharmacist making the last supply of the benefit, and the carbon copy (to be preprinted with "HIC/DVA copy") will be used by the approved pharmacist in making claims for payment. These arrangements will apply only to the new forms; the current procedures will continue to apply in respect of prescription forms already on issue to medical practitioners and participating dental practitioners.

Consultations on this change have been held with the Australian Medical Association, the Royal Australian College of General Practitioners, the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia.

Currently a pharmaceutical benefit can be supplied if the prescription is presented for first dispensing up to the day before the first anniversary of the date of prescribing. However, a prescription presented for repeat dispensing up to and including the first anniversary of the date of prescribing is valid.

The regulations standardise these provisions allowing the supply of a pharmaceutical benefit, whether it is a first dispensing or a repeat dispensing, up to and including the first anniversary of the date of prescribing. This brings the provisions into fine with the Health Insurance Commission's processing system, which tests the date of validity of prescriptions by comparing the date the prescription was written with the date of supply of the benefit.

Details of the Regulations are in the Attachment.

The Regulations commenced on 1 January 1999.

ATTACHMENT

Regulation 1 of the amending regulations provides that the name of the amending regulations is the National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1).

Regulation 2 of the amending regulations provides that the amending regulations commence on 1 January 1999.

Regulation 3 of the amending regulations provides that the National Health (Pharmaceutical Benefits) Regulations are amended as set out in the Schedule.

Item 1 of the Schedule amends regulation 1 of the Regulations by including in the name of the Regulations the year in which they were first made, in accordance with current drafting practice.

Item 2 of the Schedule renumbers existing regulation 4 of the Regulations as regulation 3.

Item 3 of the Schedule inserts new regulation 4. This is a transitional provision by which the Regulations as in force immediately before this amendment takes effect, will continue to apply to prescription forms currently on issue.

Item 4 inserts in Regulation 5 of the Regulations definitions of "HIC/DVA copy" and "pharmacist/patient copy", in relation to prescriptions.

Items 5 to 9 amend regulation 19 of the Regulations by moving the requirement for a prescription to be written in duplicate from paragraph 19(1)(b) to paragraph 19(1)(a), and by providing for the new labels of "pharmacist/patient copy" to be printed on the originals of prescriptions and "HIC/DVA copy" to be printed on the duplicates of prescriptions.

Items 12 to 15 amend regulation 25 of the Regulations by making it clear that when a repeat supply of a pharmaceutical benefit is made before 4 or 20 clear days, as the case may be, have expired since the previous supply, the endorsement of the words "immediate supply required" and the accompanying signature by the approved supplier are to appear on the "HIC/DVA copy of the prescription, the copy which will be used in making the claim for payment.

Items 10, 11 and 17 amend regulations 21 and 26 of the Regulations by making them consistent in that a pharmaceutical benefit, irrespective of whether it is supplied on presentation of a new prescription or of a repeat authorisation or deferred supply authorisation attached to a prescription, may be supplied up to and including the first anniversary of the date on which the prescription was written. Item 17 also provides that a pharmaceutical benefit may not be supplied on presentation of only the pharmacist/patient copy of the prescription unless it is accompanied by a related repeat authorisation or deferred supply authorisation.

Items 18 and 19 amend a number of provisions of the Regulations by substituting references to the pharmacist/patient copy of the prescription for references to the duplicate of the prescription.

Overview

The National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1) were enacted in 1998 and were issued by the Minister for Health and Aged Care under the authority of the National Health Act 1953. This regulatory amendment aimed to address the deterioration of carbon copies on existing prescription forms, which could compromise patient safety, and to standardise the validity period for both initial and repeat supplies of pharmaceutical benefits under prescriptions. The policy objective was to enhance the quality and safety of prescription handling and supply within the National Health (Pharmaceutical Benefits) Regulations. The regulations introduced new style prescription forms with improved labelling and circulation procedures to ensure better readability and traceability of prescriptions. The original prescription form, now labelled "pharmacist/patient copy," will accompany the patient and any repeat authorisations, while the carbon copy, labelled "HIC/DVA copy," will be used by the pharmacist for payment claims. This change aimed to streamline the prescription process and align it with the Health Insurance Commission's processing system. The new regulations also standardised the validity period for both initial and repeat dispensing of pharmaceutical benefits to the first anniversary of the prescription date, thereby ensuring consistency and clarity in prescription supply practices.

Scope and Application

The National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1) amends the National Health (Pharmaceutical Benefits) Regulations, providing for the introduction of new prescription forms and clarifying the time frame for supplying pharmaceutical benefits. These regulations apply to medical practitioners, approved pharmacists, and entities involved in the dispensing and supply of pharmaceutical benefits under the National Health Act 1953. The changes affect the entire Commonwealth of Australia and are designed to standardise and enhance the process of prescription writing and supply, thereby improving patient safety and administrative efficiency. The amendments introduce new labels for the parts of the prescription form and modify the validity period for supplying pharmaceutical benefits to align with the Health Insurance Commission's processing system. The new regulations do not create any exclusions or exemptions but provide transitional arrangements to ensure continuity in the use of existing prescription forms until they are replaced. Subordinate instruments may further extend or restrict the application of these regulations as necessary.

Key Provisions

The National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1) (the "Regulations") amend the National Health (Pharmaceutical Benefits) Regulations (the "Principal Regulations"). These Regulations introduce new style prescription forms and alter the validity period for supplying pharmaceutical benefits under the National Health Act 1953 ("the Act"). Under section 140 of the Act, the Governor-General has the authority to make regulations necessary to carry out or give effect to the Act, including those related to the writing of prescriptions (section 105(b)). Regulation 3 of the amending regulations indicates that the Principal Regulations are amended as detailed in the Schedule, which includes changes to prescription form labelling and the validity period for supplying pharmaceutical benefits. The Regulations impose several obligations on the parties involved, including medical practitioners, pharmacists, and patients. Medical practitioners must use the new prescription forms, which now have the original and carbon copies labelled as "pharmacist/patient copy" and "HIC/DVA copy," respectively. Pharmacists are required to retain the "pharmacist/patient copy" and use the "HIC/DVA copy" when making claims for payment. Patients or their agents must sign the "pharmacist/patient copy" at the time of first supply of the pharmaceutical benefit. These changes aim to improve patient safety and ensure that the prescriptions remain legible over time. Failure to comply with the Regulations may result in legal consequences. While the Regulations themselves do not explicitly outline specific offences, penalties, or civil/criminal consequences for non-compliance, breaches of the Act or regulations related to pharmaceutical benefits may lead to penalties under other provisions of the Act or associated regulations. For example, supplying a pharmaceutical benefit outside the prescribed validity period could be considered non-compliance with the Act, potentially leading to fines or other penalties as outlined in the Act. Additionally, pharmacists who fail to adhere to the new prescription form requirements could face consequences for non-compliance with the regulations, although the specific penalties are not detailed in these Regulations. In summary, the National Health (Pharmaceutical Benefits) Amendment Regulations 1998 (No. 1) amend the Principal Regulations to introduce new prescription forms with specific labelling and to standardise the validity period for supplying pharmaceutical benefits. These changes impose new obligations on medical practitioners, pharmacists, and patients to use the updated forms and adhere to the revised validity period. While the Regulations do not explicitly outline penalties for non-compliance, breaches may lead to consequences under the Act or related regulations.

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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.