National Health Act 1953 - Amendment determination under section 84AF - Responsible persons (No. PB 25 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L00283 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 25 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 March 2008, was made on 1 February 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 March 2008.

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

Schedule 1: provides for the following amendments:

 

SCHEDULE 1

Additions

 

Amino acid formula   Oral liquid 130 mL, 30 (HCU Cooler)

with vitamins and

minerals without

methionine

 

Amino acid formula   Oral liquid 130 mL, 30 (TYR Cooler)

with vitamins and

minerals without

phenylalanine and

tyrosine

 

Amoxycillin with   Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic

clavulanic acid  acid (as potassium clavulanate) (GA-Amclav 500/125)

 

Amoxycillin with   Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic

clavulanic acid  acid (as potassium clavulanate) (GA-Amclav Forte 875/125)

 

Citalopram   Tablet 20 mg (as hydrobromide) (Citalobell)

 

Isoleucine with   Sachets of oral powder 4 g containing 50 mg isoleucine, 30 (Isoleucine Amino

carbohydrate   Acid Supplement)

 

Oxaliplatin   Powder for I.V. infusion 50 mg (Oxaliplan 50)

 

Oxaliplatin   Powder for I.V. infusion 100 mg (Oxaliplan 100)

 

Pemetrexed   Powder for I.V. infusion 100 mg (as disodium heptahydrate) (Alimta)

 

Trandolapril    Capsule 1 mg (Dolapril 1)

 

Trandolapril   Capsule 2 mg (Dolapril 2)

 

Trandolapril   Capsule 4 mg (Dolapril 4)

 

Trandolapril   Capsule 500 micrograms (Dolapril 0.5)

 

Valine with carbohydrate Sachets of oral powder 4 g containing 50 mg valine, 30 (Valine Amino Acid Supplement)

 

 

 

 


Deletions

 

Ipratropium  Nebuliser solution containing ipratropium bromide 250 micrograms (anhydrous) per mL, 20 mL (Atrovent)

 

Mirtazapine    Tablet 30 mg (Remeron)

 

 

 

 

 

 

 

 

 

 

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, provides the legislative basis for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable medicines. The Act was amended in 2008 to enhance the management and regulation of the PBS, particularly by introducing the concept of a 'responsible person' for certain pharmaceutical brands. This legislative amendment was made to address the need for better accountability and oversight in the supply chain of listed drugs on the PBS. The amendment empowers the Minister to determine specific entities as responsible persons for certain pharmaceutical brands, thereby ensuring that these entities comply with obligations such as price disclosure and supply commitments. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a key role in recommending the listing of medicines on the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness. The 2008 amendment, reflected in instrument F2008L00283, further refined the determination of responsible persons, aligning with the policy objective of improving the efficiency and reliability of the PBS.

Scope and Application

The National Health Act 1953 Amendment Determination under section 84AF pertains to the Pharmaceutical Benefits Scheme (PBS), which ensures reliable, timely, and affordable access to a range of medicines for Australians. The Act applies to entities that supply pharmaceutical benefits, particularly focusing on the declaration and listing of drugs by the Minister, as well as the designation of responsible persons for specific brands of pharmaceutical items. These responsible persons, who must notify the Minister of their supply activities, are bodies corporate identified in the schedule of the instrument by their company name and Australian Business Number (ABN). The instrument amends previous determinations to update the list of responsible persons, reflecting recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The instrument commenced on 1 March 2008, and it includes amendments to the determination made by legislative instrument number PB 90 of 2007, which came into effect on 1 December 2007. The changes involve the addition and removal of certain pharmaceutical items from the list of those for which responsible persons are designated. The Act's application is national, extending across Australia and governed by the Commonwealth.

Key Provisions

The primary operative sections of this legislation are sections 84AF, 85(1), 85(2), and 85(3) 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 if that person has notified the Minister that they will supply the brand to wholesalers or directly to approved pharmacists. Section 85(1) outlines the provision of benefits by the Commonwealth under the Pharmaceutical Benefits Scheme (PBS) in accordance with Part VII of the Act. Section 85(2) allows the Minister to declare drugs and medicinal preparations as listed drugs by legislative instrument, while section 85(3) enables the Minister to determine the form or forms of a listed drug. This instrument, commencing on 1 March 2008, amends the determination under section 84AF made by legislative instrument number PB 90 of 2007, and it lists specific brands of pharmaceutical items and their respective responsible persons. The Act imposes several obligations and requirements on the parties it governs. The responsible persons for the listed pharmaceutical items must ensure compliance with price agreements under section 85AD, adhere to price disclosure requirements under Division 3B, and supply certain brands for a specified period under Division 3C. Additionally, each responsible person must have notified the Minister of their intent to supply the pharmaceutical item to wholesalers or directly to approved pharmacists before being determined as the responsible person under section 84AF. Pharmaceutical companies must also consult with the Pharmaceutical Benefits Advisory Committee (PBAC) and other relevant stakeholders during the policy development and implementation phases. Under this legislation, there are no explicit offences, penalties, or civil/criminal consequences mentioned for breach. However, failure to comply with the obligations and requirements outlined in the Act, such as not adhering to price agreements or supplying pharmaceutical items as required, could result in enforcement actions by the Minister. Such actions may include the revocation of the responsible person status or other regulatory measures to ensure compliance with the PBS 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.