National Health Act 1953 - Amendment Determination under section 84AF - Responsible persons (No. PB 8 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L04905 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 8 OF 2008

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 90 of 2007 which came into effect on 1 December 2007.  The amendments are set out in the items of Schedule 1 to the instrument.

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

This instrument, expressed to commence on 1 January 2008, was made on 14 December 2007.

Another legislative instrument expressed to commence on 1 January 2008 and made by the Minister on
19 November 2007 also amends determinations under section 84AF made by legislative instrument number PB 90 of 2007.  It is intended that both this legislative instrument and the legislative instrument made by the Minister on 19 November 2007 amend the legislative instrument number PB 90 of 2007 with effect on 1 January 2008.

 

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 January 2008.

Paragraph 2: provides that Schedule 1 amends PB 90 of 2007.

Schedule 1: provides for the following amendments:

 

SCHEDULE 1

 

Additions

 

Cefaclor Powder for oral suspension 125 mg (as monohydrate) per 5 mL, 100 mL (Ozcef)

 Powder for oral suspension 250 mg (as monohydrate) per 5 mL, 75 mL (Ozcef)

 

Cephalexin Capsule 250 mg (anhydrous) (Cephabell)

 Capsule 500 mg (anhydrous) (Cephabell)

 

Influenza Vaccine Injection containing inactivated, split virion influenza vaccine, 0.25 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 7.5 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 7.5 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 7.5 micrograms haemagglutinin; 0.25 mL pre-filled syringe (Vaxigrip Junior)

 

Paracetamol Tablet 500 mg (Paracetamol Sandoz)

 

Paroxetine Tablet 20 mg (as hydrochloride) (Paroxetine Winthrop)

 

Sertraline Tablet 50 mg (as hydrochloride) (Sertraline generichealth)

 Tablet 100 mg (as hydrochloride) (Sertraline generichealth)

 

Simvastatin Tablet 10 mg (Simvastatin generichealth)

 Tablet 20 mg (Simvastatin generichealth)

 Tablet 40 mg (Simvastatin generichealth)

 Tablet 80 mg (Simvastatin generichealth)

 

  

Deletions

 

Amoxycillin Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL (Amohexal)

 

Calcium Tablet 600 mg (as carbonate) (Caltrate)

 

Ciprofloxacin Tablet 250 mg (as hydrochloride) (Ciprofloxacin-BC)

 Tablet 500 mg (as hydrochloride) (Ciprofloxacin-BC)

 

Glucose Indicator – Blood Electrode strips, 50 (Ascensia Elite)

 Discs containing electrode sensors, 10 sensors per disc, 5 (Ascensia Glucodisc)

 

 

Oestradiol Transdermal patches 3.28 mg, 8 (Menorest 37.5)

 Transdermal patches 4.33 mg, 8 (Menorest 50)

 Transdermal patches 6.57 mg, 8 (Menorest 75)

 Transdermal patches 8.66 mg, 8 (Menorest 100)

 

Pilocarpine Eye drops containing pilocarpine hydrochloride 5 mg per mL, 15 mL (P.V. Carpine; Pilopt)

 

Thioridazine   Tablet containing thioridazine hydrochloride 10 mg (Aldazine 10)

 Tablet containing thioridazine hydrochloride 25 mg (Aldazine 25)

 Tablet containing thioridazine hydrochloride 50 mg (Aldazine 50)

 Tablet containing thioridazine hydrochloride 100 mg (Aldazine 100)

 

 

Alteration of Brand

 

Paroxetine [Tablet 20 mg (as hydrochloride)]

From: Oxetine

To:  Paroxetine Sandoz

 

Tamoxifen [Tablet 20 mg (as citrate)]

From: Tamoxifen Hexal

To:  Tamoxifen Sandoz

 

 

Alteration of Responsible Person

 

Diphenoxylate with Atropine [Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms (Lofenoxal)]

From: Pfizer Australia Pty Ltd (ABN 50 008 422 348)    

To:   Biotech Pharmaceuticals Pty Ltd (ABN 91 009 701 517)

 

Diphenoxylate with Atropine [Tablet containing diphenoxylate hydrochloride 2.5 mg with atropine sulfate 25 micrograms (Lomotil)]

From: Pfizer Australia Pty Ltd (ABN 50 008 422 348)    

To:   Biotech Pharmaceuticals Pty Ltd (ABN 91 009 701 517)

 

 

Overview

The National Health Act 1953, as amended by the National Health Amendment (Pharmaceutical Benefits Scheme) Determination 2007, aims to provide Australians with reliable, timely, and affordable access to a wide range of medicines through the Pharmaceutical Benefits Scheme (PBS). This legislation was enacted by the Australian Parliament and addresses the need for a structured and regulated approach to the distribution and availability of pharmaceutical benefits. The policy objective of this amendment is to ensure the efficient and effective operation of the PBS by clearly defining the roles and responsibilities of entities involved in the supply chain of pharmaceutical items, particularly the designation of responsible persons for specific brands of pharmaceutical items. This amendment determination under section 84AF of the Act empowers the Minister for Health to designate a person as the responsible person for a brand of a pharmaceutical item, a role that includes responsibilities such as entering into price agreements, complying with price disclosure requirements, and ensuring the supply of certain brands for a specified period. This legislative instrument, effective from 1 January 2008, identifies specific brands and their corresponding responsible persons, amending previous determinations to align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, recommends which drugs should be available as pharmaceutical benefits, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness.

Scope and Application

The National Health Act 1953 Amendment Determination under section 84AF sets out the specific brands of pharmaceutical items and the companies responsible for supplying these brands to wholesalers or directly to approved pharmacists under the Pharmaceutical Benefits Scheme (PBS). This determination applies to bodies corporate, which must be notified to the Minister and identified by their company name and Australian Business Number (ABN). The instrument amends the determination under section 84AF made by legislative instrument number PB 90 of 2007, effective from 1 January 2008. The amendment involves the addition, deletion, and alteration of brands and responsible persons for pharmaceutical items listed on the PBS, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an expert body established by the Act, makes recommendations based on the clinical effectiveness, safety, and cost-effectiveness of drugs and medicinal preparations. The amendment instrument ensures compliance with the provisions of the National Health Act 1953 concerning the PBS, thereby maintaining the scheme's objective of providing affordable access to a wide range of medicines for Australians.

Key Provisions

The legislative instrument (F2007L04905) amends the determination under section 84AF of the National Health Act 1953, which relates to the Pharmaceutical Benefits Scheme (PBS). This Act, particularly Part VII, ensures Australians have access to affordable and reliable medications. The Minister, under this Act, has the authority to declare certain drugs and medicinal preparations as listed drugs (subsection 85(2)) and can specify the form of these drugs, their administration, and the brands available under the scheme (subsections 85(3), 85(5), and 85(6)). Additionally, the Minister can determine who is responsible for supplying these pharmaceutical items (subsection 84AF). The instrument specifically amends the determinations made by PB 90 of 2007 to reflect new responsible persons for certain brands of pharmaceutical items listed on Schedule 1. The obligations imposed by this Act on pharmaceutical companies include ensuring that they are designated as the responsible person for specific brands of medications listed on the PBS. This designation comes with several responsibilities, such as entering into price agreements with the Commonwealth (section 85AD), complying with price disclosure requirements (Division 3B), and ensuring the supply of specified brands of pharmaceutical items for a certain period (Division 3C). Companies must notify the Minister of their intention to supply these brands to wholesalers or directly to approved pharmacists. They must also ensure they meet the criteria set out in section 84AF, including being the only party with a determination in force for that brand. Failure to comply with the obligations under this Act can lead to various civil and criminal consequences. While the specific penalties are not detailed in the explanatory statement, breaches of the National Health Act 1953 can generally result in substantial fines and, in some cases, imprisonment. The severity of the penalty often depends on the nature and extent of the breach. Companies found in non-compliance may face legal action, including fines and potential disqualification from participating in the PBS, which could significantly impact their ability to operate in the Australian market.

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