National Health Act 1953 - Amendment determinations under sections 85, 85A and 88 - pharmaceutical benefits (No. PB 30 of 2010)

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Legislation au F2010L00773 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 30 OF 2010

NATIONAL HEALTH ACT 1953

DETERMINATIONS UNDER SECTIONS 85, 85A and 88

 

Summary

This instrument amends the principal legislative instrument, PB 15 of 2010, which gives effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and provides for additions, deletions and changes to the names, forms, manners of administration, and brands of listed drugs on the PBS and the conditions for prescribing pharmaceutical benefits.  Due to an administrative oversight, the “type of unit” for all forms of the listed drug dabigatran etexilate has been incorrectly described as “tablet” or “tablets” in instrument PB 15 of 2010 when the “type of unit” should be described as “capsule” or “capsules” wherever occurring.

Purpose and operation

Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.

Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.

Drugs and medicinal preparations to which Part VII applies are declared by the Minister by legislative instrument to be so under subsection 85(2).  These are listed drugs as defined in subsection 84(1).  Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).

Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.

Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).

Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item.  A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item,  or if there is no trade name, the name of the responsible person.  The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.

Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit.  Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose.  Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose.  Paragraph 85A(2)(c) authorises the determination of the manner of administration that may in a prescription be directed to be used. 

Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits.  Subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.

This amending instrument amends the principal instrument before it commences by removing the reference to “tablet” or “tablets” by substituting with “capsule” or “capsules”. The correct forms for the listed drug dabigatran etexilate are capsules 75 mg (as mesilate), 60; capsules 110 mg (as mesilate), 60; capsule 75 mg (as mesilate) and capsule 110 mg (as mesilate). The amendment is set out in Schedule 1 to the instrument.

This instrument, expressed to commence on the day after registration on the Federal Register of Legislative Instruments, was made on 26 March 2010, and is intended to have effect before commencement of PB 15 of 2010, which commences on 1 April 2010.

 

Consultations

This amendment is required to be made as a result of an administrative oversight.  The responsible person that supplies the listed drug dabigatran etexilate in the forms capsules 75 mg (as mesilate), 60; capsules 110 mg (as mesilate), 60; capsule 75 mg (as mesilate) and capsule 110 mg (as mesilate) has been advised of this correction. Medicare Australia has been advised of this correction for the purposes of administering payments for the supply of these pharmaceutical benefits.

 

 

 

Overview

The F2010L00773 instrument, made under the National Health Act 1953, addresses an administrative oversight in the description of the "type of unit" for the listed drug dabigatran etexilate on the Pharmaceutical Benefits Scheme (PBS). Enacted in 2010, this instrument amends the Pharmaceutical Benefits Instrument (PB 15 of 2010) to rectify the incorrect designation of dabigatran etexilate from "tablet" to "capsule" for all forms. This amendment ensures accurate documentation and administration of pharmaceutical benefits by correcting the misclassification of the drug's form. The objective of this legislative instrument is to maintain the integrity of the PBS by ensuring that the listed drugs are correctly described, facilitating proper prescription and supply of pharmaceutical benefits to Australians.

Scope and Application

The National Health Act 1953, as amended by the instrument PB 30 of 2010, applies to the Pharmaceutical Benefits Scheme (PBS) which facilitates the provision of affordable and accessible medicines to Australians. The Act empowers the Minister for Health to make determinations regarding the forms, administration, and brands of listed drugs under sections 85, 85A, and 88. This includes defining the strength, type of unit, size, and manner of administration for pharmaceutical items, as well as specifying brands and prescription details. The instrument specifically addresses an oversight in the description of the form of the drug dabigatran etexilate, correcting the type of unit from "tablet" to "capsule." This legislative instrument operates nationally across Australia, ensuring the correct application of the PBS throughout the Commonwealth. The instrument does not introduce any new exclusions or exemptions but rectifies an administrative error in the previous instrument, ensuring compliance with the correct pharmaceutical standards and definitions.

Key Provisions

The main operative sections of the amending instrument, F2010L00773, pertain to sections 85, 85A, and 88 of the National Health Act 1953. These sections are integral to the administration of the Pharmaceutical Benefits Scheme (PBS) by outlining the Minister's authority to declare, determine, and specify aspects related to listed drugs and pharmaceutical benefits. Specifically, subsection 85(1) mandates the provision of benefits by the Commonwealth, while subsection 85(2) allows the Minister to declare drugs and preparations applicable under the PBS. Subsection 85(3) authorises the Minister to specify the forms of a listed drug, and subsection 85(5) allows for the determination of the manner of administration for these forms. Subsection 85A(2) and section 88 further enable the Minister to determine prescription writing stipulations, including maximum quantities, repetitions, and administration methods. The Act imposes various obligations on the parties it governs, primarily focusing on the accurate declaration and administration of pharmaceutical benefits. The Minister, under sections 85(2) and 85(3), is required to accurately declare which drugs and preparations are subject to the PBS and to specify their forms. Additionally, the Minister must determine prescription conditions under section 85A(2) and dental practitioner authorisations under section 88(1A). Pharmaceutical companies and suppliers must adhere to these declarations and specifications when supplying listed drugs and administering pharmaceutical benefits. Failure to comply with the provisions of the Act may result in various consequences. Although the specific offences, penalties, or civil/criminal consequences are not detailed within the instrument, general provisions under the National Health Act 1953 may apply. Penalties for non-compliance can include fines and, in severe cases, imprisonment. Additionally, entities that fail to adhere to the Act's stipulations regarding the PBS may face administrative sanctions, including the suspension or revocation of their pharmaceutical benefits listings. These potential consequences underscore the importance of accurate compliance with the legislative requirements set forth in the Act.

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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.