National Health Act 1953 - Amendment declaration under subsections 85(2) and 85(2AA) - Amendment determination under subsection 85(2A) - drugs and medicinal preparations (No. PB 97 of 2008)

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Legislation au F2008L03754 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 97 OF 2008

NATIONAL HEALTH ACT 1953

AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)

    AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)

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 in relation to which Part VII applies are declared by the Minister by legislative instrument as such 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.

This legislative instrument in giving effect to recommendations of the PBAC amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 74 of 2008 which came into effect on 1 August 2008.  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 November 2008, was made on 2 October 2008.

 


Consultations

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.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 2008.

Paragraph 2:  provides that Schedule 1 amends PB 74 of 2008.

Schedule 1: provides for the following amendments:

 

Amendment of Paragraph 3 to add the definitions for “GP Management Plan” and “Team Care Arrangements”.  The provisions and definitions of the “GP Management Plan” and “Team Care Arrangements” are set out in the Health Insurance (General Medical Services Table) Regulations 2008.

 

SCHEDULE 1

Alteration of Circumstances

Atomoxetine

Bortezomib

Cabergoline [deletion of the form tablet 4 mg]

Carbomer 980 [addition of circumstance for ocular lubricating gel 2 mg per g, 10 g]

Carmellose [addition of circumstance for eye drops containing carmellose sodium 5 mg per mL, 15 mL and eye drops containing carmellose sodium 10 mg per mL, 15 mL]

Dasatinib [for the treatment of patients with “Chronic myeloid leukaemia”]

Hypromellose

Hypromellose with Carbomer 980

Hypromellose with Dextran [addition of circumstance for eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL]

Imatinib [for the continuing treatment of patients with “Myelodysplastic or myeloproliferative disorder” and “Systemic mastocytosis with eosinophilia”]

Mesalazine [addition of the sachet containing granules, 1.5 g per sachet]

Nilotinib

Polyethylene Glycol 400 with Propylene Glycol [addition of circumstance for eye drops 4 mg-3 mg per mL, 15 mL; alteration to the form for eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28]

Polyvinyl Alcohol

Quetiapine [addition of the tablet (modified release) 50 mg (as fumarate), tablet (modified release) 200 mg (as fumarate), tablet (modified release) 300 mg (as fumarate) and tablet (modified release) 400 mg (as fumarate) and addition of new circumstances] [specify that tablet 25 mg (as fumarate), tablet 100 mg (as fumarate), tablet 200 mg (as fumarate) and tablet 300 mg (as fumarate) relate to the existing circumstance]

Rosiglitazone

Rosiglitazone with Metformin

Thyrotropin Alfa

Tramadol [alteration to the form description for the tablet (sustained release) containing tramadol hydrochloride 50 mg, tablet (sustained release) containing tramadol hydrochloride 100 mg, tablet (sustained release) containing tramadol hydrochloride 150 mg and tablet (sustained release) containing tramadol hydrochloride 200 mg and addition of tablet (extended release) containing tramadol hydrochloride 100 mg, tablet (extended release) containing tramadol hydrochloride 200 mg and tablet (extended release) containing tramadol hydrochloride 300 mg]


 

SCHEDULE 2

Alteration of Circumstances

Tramadol [alteration to the form description for the tablet (sustained release) containing tramadol hydrochloride 50 mg, tablet (sustained release) containing tramadol hydrochloride 100 mg, tablet (sustained release) containing tramadol hydrochloride 150 mg and tablet (sustained release) containing tramadol hydrochloride 200 mg and addition of tablet (extended release) containing tramadol hydrochloride 100 mg, tablet (extended release) containing tramadol hydrochloride 200 mg and tablet (extended release) containing tramadol hydrochloride 300 mg]

 

SCHEDULE 2A

Alteration of Circumstances

Polyethylene Glycol 400 with Propylene Glycol [alteration to the form description for eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28]

Overview

The National Health Act 1953, as amended by the legislation F2008L03754, aims to provide a legislative framework for the Pharmaceutical Benefits Scheme (PBS). The Act was enacted to ensure that all Australians have reliable, timely, and affordable access to a wide range of medicines. The amendments introduced by F2008L03754, made under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A), are designed to update the list of drugs covered under the PBS and to specify the forms and circumstances under which these drugs can be administered. These amendments follow recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), which consults with various stakeholders, including consumers and health professionals, to assess the clinical effectiveness, safety, and cost-effectiveness of medicines. The amendments to the Act are intended to ensure that the PBS continues to provide access to essential and necessary medications for the Australian public.

Scope and Application

The National Health Act 1953 Amendment Declaration under Subsections 85(2) and 85(2AA) Amendment Determination under Subsection 85(2A) pertains to the Pharmaceutical Benefits Scheme (PBS) as administered by the Commonwealth to ensure that all Australians have reliable, timely, and affordable access to a broad range of medications. This legislation applies to listed drugs and medicinal preparations as defined in subsection 84(1) and includes certain extemporaneously-prepared pharmaceutical benefits. The Minister is empowered to declare these listed drugs through legislative instruments and determine their form, manner of administration, and brand, which collectively define the pharmaceutical benefit under Part VII of the Act. The amendments detailed in this instrument, which commenced on 1 November 2008, are designed to refine the scope and details of the listed drugs and their applicable conditions as recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC, an independent expert body, provides recommendations to the Minister on the availability of drugs on the PBS, taking into account factors such as clinical effectiveness, safety, and cost-effectiveness. The amendments also incorporate definitions for "GP Management Plan" and "Team Care Arrangements" as set out in the Health Insurance (General Medical Services Table) Regulations 2008.

Key Provisions

The primary operative sections of the instrument, F2008L03754, involve amendments to the National Health Act 1953, specifically focusing on the Pharmaceutical Benefits Scheme (PBS). These amendments, as outlined in Schedule 1, are made under subsections 85(2) and 85(2AA) and are determined under subsection 85(2A). They reflect the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and adjust the declarations and determinations made by legislative instrument number PB 74 of 2008 which took effect on 1 August 2008. The amendments are detailed in the items of Schedule 1 to the instrument and are set to commence on 1 November 2008. The Act imposes specific obligations on parties and entities it governs, particularly concerning the listing of drugs and medicinal preparations on the PBS. The Minister, under subsection 85(2), declares the drugs and medicinal preparations that fall under the PBS. These are listed drugs as defined in subsection 84(1). The Minister also determines the form of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)), the manner of administration (subsection 85(5)), and the brand (subsection 85(6)). These determinations govern what constitutes the pharmaceutical benefit under Part VII of the Act. The PBAC, an independent expert body established by section 100A, makes recommendations to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits. Any breach of the obligations and requirements set forth by the Act may lead to legal consequences. The Act does not explicitly state penalties for violations within this context. However, general principles of administrative law and the specific provisions of the National Health Act 1953 may apply, potentially leading to civil or administrative penalties for non-compliance. The precise nature and extent of these penalties would depend on the specific breach and the context in which it occurs. It is essential for parties governed by the Act to ensure strict adherence to its requirements to avoid any legal repercussions.

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