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National Health Act 1953 - Amendment determination under section 84AF (No. PB 63 of 2007)

National Health Act 1953 - Amendment determination under section 84AF (No. PB 63 of 2007)

Administered by Department of Health, Disability and Ageing

Legislation au F2007L02631 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 63 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.

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

This instrument, expressed to commence on 1 September 2007, was made on 14 August 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 September 2007.

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

Schedule 1: provides for the following amendments:

SCHEDULE 1

ADDITIONS

Adalimumab	Injection 40 mg in 0.8 mL pre-filled pen		Injection	Humira	Abbott Australasia Pty Ltd	95 000 180 389
Cetuximab	Solution for I.V. infusion 100 mg in 50 mL		Injection	Erbitux	Merck Serono Australia Pty Ltd	72 006 900 830
Codeine with Paracetamol	Tablet containing codeine phosphate 30 mg with paracetamol 500 mg		Oral	Comfarol Forte	sanofi-aventis Australia Pty Ltd	31 008 558 807
Fluconazole	Solution for I.V. infusion 400 mg in 200 mL		Injection	Baxter Healthcare Pty Ltd	Baxter Healthcare Pty Ltd	43 000 392 781
Fosinopril with Hydrochlorothiazide	Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5 mg		Oral	Hyforil	Ranbaxy Australia Pty Limited	17 110 871 826
Fosinopril with Hydrochlorothiazide	Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg		Oral	Hyforil	Ranbaxy Australia Pty Limited	17 110 871 826
Lumiracoxib	Tablet 100 mg		Oral	Prexige	Novartis Pharmaceuticals Australia Pty Ltd	18 004 244 160
Meloxicam	Tablet 7.5 mg		Oral	Meloxicam-GA	Genepharm Limited	17 003 854 626
Meloxicam	Tablet 15 mg		Oral	Meloxicam-GA	Genepharm Limited	17 003 854 626
Omeprazole	Tablet 20 mg		Oral	Omeprazole-GA	Genepharm Limited	17 003 854 626
Ondansetron	I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL		Injection	Onsetron	Arrow Pharmaceuticals Pty Ltd	17 003 144 170
Ondansetron	I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL		Injection	Onsetron	Arrow Pharmaceuticals Pty Ltd	17 003 144 170
Phenoxybenzamine	Capsules containing phenoxybenzamine hydrochloride 10 mg, 30		Oral	Dibenyline	Goldshield Healthcare (Australia) Pty Limited	91 118 106 684
Ramipril	Tablet 10 mg		Oral	Tritace	sanofi-aventis Australia Pty Ltd	31 008 558 807
Valproic Acid		Tablet (enteric coated) containing sodium valproate 200 mg	Oral	Sodium Valproate Sandoz	sanofi-aventis Australia Pty Ltd		31 008 558 807
Valproic Acid		Tablet (enteric coated) containing sodium valproate 500 mg	Oral	Sodium Valproate Sandoz	sanofi-aventis Australia Pty Ltd		31 008 558 807

DELETIONS

Ampicillin	Capsule 250 mg (as trihydrate)	Oral	Alphacin 250	Alphapharm Pty Ltd	93 002 359 739
Ampicillin	Capsule 500 mg (as trihydrate)	Oral	Alphacin 500	Alphapharm Pty Ltd	93 002 359 739
Levonorgestrel	Tablets 30 micrograms, 28	Oral	Microval 28	Wyeth Australia Pty Limited	16 000 296 211
Lumiracoxib	Tablet 200 mg	Oral	Prexige	Novartis Pharmaceuticals Australia Pty Ltd	18 004 244 160
"Phenex-1"	Oral powder 350 g	Oral	Phenex-1	Abbott Australasia Pty Ltd	95 000 180 389

ALTERATIONS

Alterations – Forms

Fluconazole	From:
	Solution for I.V. infusion 100 mg in 50 mL vial
	To:
	Solution for I.V. infusion 100 mg in 50 mL
Fluconazole	From:
	Solution for I.V. infusion 200 mg in 100 mL vial
	To:
	Solution for I.V. infusion 200 mg in 100 mL

Overview

The National Health Act 1953, enacted by the Australian Parliament, provides the legislative foundation for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to affordable and reliable medicines. This legislation, through its various amendments, aims to address gaps in the availability, affordability, and quality of medications within the PBS. The Act allows the Minister for Health to determine the form, administration, and brand of listed drugs, as well as designate responsible persons for pharmaceutical brands, ensuring compliance and effective supply chain management. The 2007 amendment determination under section 84AF of the Act identifies specific corporate entities as responsible persons for certain pharmaceutical brands, thereby clarifying responsibilities and ensuring the smooth operation of the PBS by aligning with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC).

Scope and Application

The National Health Act 1953 Amendment Determination under section 84AF, represented by instrument number PB 63 of 2007, is designed to regulate and refine the administration of the Pharmaceutical Benefits Scheme (PBS) in Australia. This Act applies to pharmaceutical companies, entities, and their brands that supply listed drugs and medicinal preparations as pharmaceutical benefits under Part VII of the Act. The legislation establishes the parameters for what constitutes a pharmaceutical benefit, including the form, manner of administration, and brand of a pharmaceutical item, as determined by the Minister. The Act is of national scope, applying across the Commonwealth of Australia and is implemented through legislative instruments that extend and specify the application of the Act. Notably, this Act does not apply to certain extemporaneously-prepared medicinal preparations, which are subject to separate declarations and regulations. The instrument also includes specific amendments to the previously issued determination under PB 50 of 2007, effective from 1 September 2007, thereby altering the list of pharmaceutical items and their responsible persons. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drugs for inclusion on the PBS, ensuring that the decisions align with medical, safety, and cost-effectiveness criteria.

Key Provisions

The main operative sections of this legislation are sections 84AF and 85 of the National Health Act 1953, which deal with the Pharmaceutical Benefits Scheme (PBS) and the listing of pharmaceutical benefits. Section 84AF allows the Minister to determine a person as the responsible person for a brand of pharmaceutical item, while section 85 outlines how the Minister can declare the form, administration, and brands of pharmaceutical items that are eligible for benefits under the PBS. These provisions ensure that the PBS operates smoothly by clearly defining the roles and responsibilities of those involved in supplying PBS-listed medications. The obligations and requirements imposed by this legislation primarily concern pharmaceutical companies and the Minister. Pharmaceutical companies that are designated as responsible persons must comply with several key obligations, including entering into price agreements under section 85AD, adhering to price disclosure requirements under Division 3B, and supplying specific brands of pharmaceutical items for a specified period under Division 3C. These obligations are crucial for ensuring that medications are accessible and affordable for Australians. The Minister, on the other hand, must make determinations about the form, administration, and brands of pharmaceutical items and decide who the responsible person for a brand is, based on notifications from pharmaceutical companies. Failure to comply with the requirements and obligations outlined in this legislation can lead to significant consequences. While specific offences and penalties are not detailed in the text, it can be inferred that non-compliance with the PBS regulations could result in civil or criminal penalties, given the critical nature of the PBS in providing accessible healthcare. The exact penalties would depend on the nature and severity of the breach, but they could include fines or other sanctions that aim to enforce adherence to the PBS framework and protect public health. The legislative instrument, effective from 1 September 2007, amends previous determinations and specifies new responsible persons for certain pharmaceutical brands, ensuring that the PBS continues to function effectively. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a significant role in recommending drugs for inclusion on the PBS, taking into account factors such as clinical effectiveness and cost-effectiveness. This ensures that the PBS remains a viable and efficient system for providing essential medications to Australians.

Area of Law: Health Law
Instrument: Regulation
Concepts: Definitions & Interpretation; Reporting & Disclosure Obligations; Compliance Obligations

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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.

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