National Health Act 1953 - Amendment determination under section 84AF - Responsible Persons (No. PB 80 of 2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L03944 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 80 OF 2007

NATIONAL HEALTH ACT 1953

AMENDMENT DETERMINATION UNDER SECTION 84AF

 

 

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).

The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)).  These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.

Section 84AF empowers the Minister to determine that a person is the responsible person for a brand of a pharmaceutical item.  The Minister can do this if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item to wholesalers or, if not, to approved pharmacists directly.  The brand must be a listed brand (defined in subsection 84(1) as a brand in relation to which a determination under subsection 85(6) is in force), and there can be no determination in force that any other person is the responsible person for the brand of the pharmaceutical item or of any other pharmaceutical item.

A responsible person for a brand of pharmaceutical item has various responsibilities or functions under the Act.  These include those in relation to entering into price agreements under section 85AD, compliance with price disclosure requirements under Division 3B, and the requirement to supply certain brands of pharmaceutical item for a specified period under Division 3C.

This instrument determines the responsible persons for the brands of pharmaceutical items set out in Schedule 1 to the instrument.  These persons are bodies corporate and are identified in Schedule 1 by their company name and Australian Business Number (ABN).  The names of the responsible persons were notified before the commencement of section 84AF as permitted by subsection 84AF(2). 

This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under section 84AF made by legislative instrument number PB 50 of 2007 which came into effect on 1 August 2007.  The amendments are set out in the items of Schedule 1 to the instrument.

This instrument contains a number of changes in terminology to accord with amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007 which came into effect on 1 August 2007.

A provision-by-provision description of the instrument is contained in the Attachment.

This instrument, expressed to commence on 1 November 2007, was made on 2 October 2007.

 

Consultations

This instrument affects pharmaceutical companies with medicines listed on the PBS. In relation to the introduction of the responsible person measure, pharmaceutical companies have been consulted during both the policy development and implementation phases.  This has occurred through meetings with both peak body organisations and individual companies.  Information on this measure has been disseminated through peak industry bodies and during regular meetings with a Stakeholder Reference Group. Particular information on the Responsible Person provisions has been provided by letter to those companies to whom the provisions will apply. Under section 84AF the Minister may only determine a person to be the responsible person for a brand of a pharmaceutical item if the person has notified the Minister that the person is or will be the supplier of the brand of the pharmaceutical item.  Each of the persons determined in the instrument to be responsible persons has given the required notification to the Minister.

The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits.  PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  When recommending the listing of a medicine on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

ATTACHMENT

 

Paragraph 1: provides that this instrument commences on 1 November 2007.

Paragraph 2: provides that Schedule 1 amends PB 50 of 2007.

Schedule 1: provides for the following amendments:

 

SCHEDULE 1

 

Additions

 

Bortezomib Powder for injection 3.5 mg (with any determined brand of sodium chloride injection as the required solvent) (Velcade)

 

Ceftriaxone Powder for injection 1 g (as sodium) (XF)

 

Cephalexin Capsule 250 mg (anhydrous) (Cephalexin – Lupin)

 Capsule 500 mg (anhydrous) (Cephalexin – Lupin)

 

Glucose Indicator  Electrode strips, 50 (Optium Omega)

– Blood

 

Imatinib   Tablet 100 mg (as mesylate) (Glivec)

    Tablet 400 mg (as mesylate) (Glivec)

 

Meloxicam   Tablet 7.5 mg (Meloxibell; Meloxicam Ranbaxy; Pharmacor Meloxicam 7.5)

    Tablet 15 mg (Meloxibell; Meloxicam Ranbaxy; Pharmacor Meloxicam 15)

 

Mirtazapine  Tablet 30 mg (Chem mart Mirtazapine; GenRx Mirtazapine;  Terry White Chemists Mirtazapine)

 

Perindopril with   Tablet containing perindopril erbumine 4 mg with indapamide hemihydrate 1.25 mg Indapamide                                          (Perindo Combi 4/1.25)

 

Pravastatin   Tablet containing pravastatin sodium 20 mg (Vastoran)

    Tablet containing pravastatin sodium 40 mg (Vastoran)

 

Tamarindus indica   Eye drops 10 mg per mL, 0.5 mL, 20 (Visine Professional)

seed polysaccharide

 

Vancomycin Powder for injection 1 g (1,000,000 i.u.) (as hydrochloride) (MX)

 

  

Deletions

 

Simvastatin    Tablet 5 mg (Simvastatin Winthrop)

 

 

Alteration of Brand

 

Vancomycin [Powder for injection 500 mg (500,000 i.u.) as hydrochloride]

From: Vancocin

To:  Vancocin CP

 

 


Alteration of Responsible Person

 

Loperamide [Capsule containing loperamide hydrochloride 2 mg]

From: Janssen-Cilag Pty Ltd (ABN 47 000 129 975)    

To:   Johnson & Johnson Pacific Pty Ltd (ABN 73 001 121 446)

 

Sorbitol with Sodium Citrate and Sodium Lauryl Sulfoacetate [Enemas 3.125 g-450 mg-45 mg in 5 ml, 12]

From: Pfizer Pty Limited (ABN 50 008 422 348) 

To:   Johnson & Johnson Pacific Pty Ltd (ABN 73 001 121 446)

 

 

 

Overview

The National Health Act 1953, as amended by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007, establishes the legislative framework for the Pharmaceutical Benefits Scheme (PBS) in Australia. This scheme ensures that all Australians have reliable, timely, and affordable access to a wide range of medicines. The 2007 amendments introduced various provisions, including the concept of a 'responsible person' for pharmaceutical brands listed on the PBS. This amendment was enacted by the Parliament of Australia to address the need for clear accountability and responsibility for the supply of specific pharmaceutical items. The policy objective was to ensure that there is a designated responsible person for each brand of pharmaceutical item, facilitating better regulation and management of pharmaceutical benefits. The explanatory statement for the legislative instrument PB 80 of 2007, which came into effect on 1 November 2007, details the amendments to the determination of responsible persons for certain brands of pharmaceutical items listed on the PBS, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee. This legislative instrument ensures that the responsible persons for these brands have been duly notified to the Minister and have the necessary qualifications and experience to manage their responsibilities under the Act.

Scope and Application

The National Health Act 1953, through its Part VII, governs the Pharmaceutical Benefits Scheme (PBS) which ensures that Australians have reliable, timely, and affordable access to a broad range of medicines. The Act applies to drugs and medicinal preparations declared by the Minister as listed drugs under subsection 85(2), as well as certain extemporaneously-prepared medicinal preparations. The Minister can specify the form of a listed drug and the manner of its administration, which dictates what constitutes a pharmaceutical benefit under the Act. The Act also designates a responsible person for each brand of pharmaceutical item, who must notify the Minister of their intention to supply the brand to wholesalers or directly to approved pharmacists. This person has various responsibilities, including entering into price agreements and ensuring compliance with price disclosure requirements. The determination of responsible persons is outlined in Schedule 1 of the legislative instrument, which includes amendments recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The instrument also updates terminology to reflect amendments made by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007. The instrument commenced on 1 November 2007 and amends the earlier determination made under section 84AF, which took effect on 1 August 2007. Pharmaceutical companies have been consulted during the policy development and implementation phases, with particular information on the responsible person provisions provided to relevant companies by letter.

Key Provisions

The main operative sections of this legislative instrument (F2007L03944) are concerned with the Pharmaceutical Benefits Scheme (PBS) under Part VII of the National Health Act 1953. Section 84AF empowers the Minister to determine a person as the responsible person for a brand of a pharmaceutical item. This occurs if the person has notified the Minister that they are or will be the supplier of the brand of the pharmaceutical item to wholesalers or directly to approved pharmacists. The instrument amends the previous determination under section 84AF made by legislative instrument number PB 50 of 2007, which came into effect on 1 August 2007. These amendments are set out in Schedule 1, which lists the additions, deletions, and alterations of brands and responsible persons for pharmaceutical items. The obligations and requirements imposed by the Act on the parties or entities it governs include the responsibility of the determined responsible persons to enter into price agreements under section 85AD, comply with price disclosure requirements under Division 3B, and supply certain brands of pharmaceutical items for a specified period under Division 3C. The responsible persons identified in Schedule 1 by their company name and Australian Business Number (ABN) must adhere to these requirements. The instrument also includes changes in terminology to accord with amendments of the Act by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2007, which came into effect on 1 August 2007. Any offences, penalties, or civil/criminal consequences for breach of the Act are not explicitly stated in this instrument. However, it is important to note that failure to comply with the obligations and requirements set out in the Act may result in legal consequences. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending the listing of medicines on the PBS, taking into account factors such as medical conditions, clinical effectiveness, safety, and cost-effectiveness. The PBAC is an independent expert body established by section 100A, with members appointed following nomination by prescribed organisations and associations from various fields related to the functions of the PBAC.

Legal classification tags

Area of Law
Health Law
Instrument
Regulation
Concepts
Definitions & Interpretation
Regulatory Standards
Reporting & Disclosure 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.