National Health Act 1953 - Amendment determination under section 84AF - Responsible persons (No. PB 16 of 2008)

Administered by Department of Health, Disability and Ageing

Legislation au F2008L00035 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 16 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 February 2008, was made on 2 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 February 2008.

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

Schedule 1: provides for the following amendments:

 

SCHEDULE 1

Additions

 

Fosinopril   Tablet containing fosinopril sodium 10 mg (Fosinopril Winthrop)

    Tablet containing fosinopril sodium 20 mg (Fosinopril Winthrop)

 

Fosinopril with  Tablet containing fosinopril sodium 10 mg with hydrochlorothiazide 12.5mg Hydrochlorothiazide                            (Fosinopril/HCT Winthrop 10 mg/12.5 mg)

Tablet containing fosinopril sodium 20 mg with hydrochlorothiazide 12.5 mg (Fosinopril/HCT Winthrop 20 mg/12.5 mg)

 

Gabapentin Tablet 600 mg (GenRx Gabapentin)

 Tablet 800 mg (GenRx Gabapentin)

 

Omeprazole Tablet 20 mg (GenRx Omeprazole)

 

Oxybutynin Winthrop Tablet containing oxybutynin hydrochloride 5 mg (Oxybutynin Winthrop) 

 

Quinapril Tablet 5 mg (as hydrochloride) (APO-Quinapril, Phamacor Quinapril 5, Quinapril-DP)

 Tablet 10 mg (as hydrochloride) (APO-Quinapril, Phamacor Quinapril 10, Quinapril-DP)

 Tablet 20 mg (as hydrochloride) (APO-Quinapril, Phamacor Quinapril 20, Quinapril-DP)

 

Sumitriptan   Tablet 50 mg (as succinate) (Sumagran 50)

 

Deletions

 

Influenza Vaccine Injection containing  inactivated, split virion influenza vaccine , 0.5 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain 15 micrograms haemagglutinin; A/Wisconsin/67/2005 (H3N2)-like strain 15 micrograms haemagglutinin; B/Malaysia/2506/2004-like strain 15 micrograms haemagglutinin; 0.5 mL pre-filled syringe (Fluarix)

 

Isotretinoin Capsule 20 mg (Isohexal) 

 

Trimethoprim with  Tablet 80 mg-400 mg (Septrin)

Sulfamethoxazole  

 


Alteration of Item and Form

 

From:

Metoprolol Pack containing 15 tablets metoprolol succinate 23.75 mg (controlled release), 15 tablets metoprolol succinate 47.5 mg (controlled release) and 15 tablets
95 mg (controlled release)

To:

Metoprolol succinate Pack containing 15 tablets 23.75 mg (controlled release), 15 tablets 47.5 mg (controlled release) and 15 tablets 95 mg (controlled release)

 

From:

Metoprolol Tablet containing metoprolol succinate 190 mg (controlled release)

To:

Metoprolol succinate Tablet 190 mg (controlled release)

 

From:

Metoprolol Tablet containing metoprolol succinate 23.75 mg (controlled release)

To:

Metoprolol succinate Tablet 23.75 mg (controlled release)

 

From:

Metoprolol Tablet containing metoprolol succinate 47.5 mg (controlled release)

To:

Metoprolol succinate Tablet 47.5 mg (controlled release)

 

From:

Metoprolol Tablet containing metoprolol succinate 95 mg (controlled release)

To:

Metoprolol succinate Tablet 95 mg (controlled release)

 

Alteration of Form

 

Influenza Vaccine [to reflect change in formulation]

 

Alteration of Brand

 

Cephalexin [Capsule 250 mg (anhydrous), Capsule 500 mg (anhydrous)]

From: Cephalexin-Lupin

To:  Cephalexin Max

 

Alteration of Responsible Person

 

Amisulpride [Tablet 100 mg, tablet 200 mg and tablet 400 mg (Amisulpride Sandoz)]

From: sanofi-aventis Australia Pty Ltd (ABN 31 008 558 807)    

To:   Sandoz Pty Ltd (ABN 60 075 449 553)

 

Codeine with Paracetamol [Tablet containing codeine phosphate 30 mg with paracetamol 500 mg (Comfarol Forte)]

From: sanofi-aventis Australia Pty Ltd (ABN 31 008 558 807)    

To:   Sandoz Pty Ltd (ABN 60 075 449 553)

 

Diltiazem [Capsule (controlled delivery) containing diltiazem hydrochloride 180 mg, capsule (controlled delivery) containing diltiazem hydrochloride 240 mg and capsule (controlled delivery) containing diltiazem hydrochloride 360 mg (Diltahexal CD)]

From: sanofi-aventis Australia Pty Ltd (ABN 31 008 558 807)    

To:   Sandoz Pty Ltd (ABN 60 075 449 553)


Valproic Acid [Tablet (enteric coated) containing sodium valproate 200 mg and tablet (enteric coated) containing sodium valproate 500 mg (Sodium Valproate Sandoz)]

From: sanofi-aventis Australia Pty Ltd (ABN 31 008 558 807)    

To:   Sandoz Pty Ltd (ABN 60 075 449 553)

 

 

Overview

The National Health Act 1953, enacted by the Parliament of Australia, forms the legislative basis for the Pharmaceutical Benefits Scheme (PBS), which ensures Australians have access to a wide range of affordable medicines. The Act was amended by the National Health Amendment (Pharmaceutical Benefits) Determination 2008, which came into effect on 1 February 2008. This amendment, made under section 84AF of the Act, introduces a mechanism for determining the responsible persons for specific brands of pharmaceutical items listed under the PBS. The primary objective of this amendment is to ensure effective management and regulation of the supply chain for these pharmaceutical items by identifying and assigning responsibilities to specific corporate entities. This approach aims to enhance the administration and oversight of the PBS, ensuring compliance with pricing, supply, and quality standards.

Scope and Application

The National Health Act 1953, as amended, provides the legal framework for the Pharmaceutical Benefits Scheme (PBS), through which the Commonwealth ensures all Australians have reliable, timely, and affordable access to a wide range of medicines. The Act applies to listed drugs and medicinal preparations declared by the Minister, and to certain extemporaneously-prepared medicinal preparations as per the Minister's declarations. The Act applies to pharmaceutical companies and entities supplying listed drugs and brands under the PBS, with specific responsibilities assigned to the 'responsible person' for each brand, a role determined by the Minister based on notification from the entity. The determination of responsible persons is subject to consultation with relevant industry stakeholders, including peak bodies and individual companies. The instrument amending the responsible persons for specific pharmaceutical brands under the Act commenced on 1 February 2008, and it revises the determination made in 2007. The changes include additions, deletions, and alterations to the brands and their responsible persons, reflecting the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is an independent expert body that advises the Minister on which drugs and medicinal preparations should be included in the PBS, considering factors such as clinical effectiveness, safety, and cost-effectiveness.

Key Provisions

The main sections of this legislative instrument under the National Health Act 1953 focus on the determination of responsible persons for brands of pharmaceutical items listed under the Pharmaceutical Benefits Scheme (PBS). Under section 84AF, the Minister can determine a person as the responsible person for a brand of a pharmaceutical item if the person has notified the Minister that they will be the supplier of that brand to wholesalers or directly to approved pharmacists. These responsible persons are designated for brands of pharmaceutical items listed in Schedule 1 of the instrument, which includes various drug brands such as Fosinopril, Gabapentin, Omeprazole, and others. These determinations are made to ensure that the respective companies are accountable for the supply and compliance of these pharmaceutical items under the PBS. The obligations imposed on the parties governed by this Act include notifying the Minister of their intention to supply a brand of pharmaceutical item, ensuring compliance with price agreements, and adhering to price disclosure requirements. Furthermore, responsible persons must supply certain brands of pharmaceutical items for a specified period as mandated by Division 3C of the Act. This ensures that the pharmaceutical items are consistently available and affordable to Australians under the PBS. Failure to comply with the provisions of the National Health Act 1953 can result in various civil or criminal consequences. While the specific offences and penalties are not detailed in this instrument, general penalties for breaches of health-related legislation can include fines and, in severe cases, imprisonment. The exact penalties depend on the nature and severity of the breach, but they are intended to enforce compliance and maintain the integrity of the PBS.

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