National Health Act 1953 - Amendment Special Arrangements under subsection 100(1) - Highly Specialised Drugs Program (No. PB 35 of 2009)

Administered by Department of Health, Disability and Ageing

Legislation au F2009L01254 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 35 of 2009

NATIONAL HEALTH ACT 1953

AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)

HIGHLY SPECIALISED DRUGS PROGRAM

 

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 (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).

Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:                

(a) who are living in isolated areas; or

(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits: 

(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or

(ii) are inadequate for that medical treatment.

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).

The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.

The Highly Specialised Drugs Program is a set of Arrangements made under subparagraph 100(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge.

This legislative instrument amends the Arrangements made under subparagraph 100(b)(i) (PB 120 of 2008) which came into effect on 1 December 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 May 2009, was made on 2 April 2009.

Consultations

The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits.  Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared.  When recommending a medicine be listed 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.

PBAC members are selected 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.

The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) is a non-statutory body established by the Australian Health Ministers Advisory Council (AHMAC).  The HSDWP makes recommendations to the PBAC on the suitability of certain drugs for listing under the Highly Specialised Drugs Program.  The HSDWP considers the funding and administrative aspects of supply through the hospital system, and a recommendation for listing must be supported by a majority of Working Party members.  The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.

 


ATTACHMENT

Paragraph 1:  provides that this instrument commences on 1 May 2009.

Paragraph 2:  provides that Schedule 1 amends PB 120 of 2008.

Schedule 1: provides for the following amendments: 

 

SCHEDULE 1

Listed Drug Added

Lanthanum

 

Alteration of Circumstances

Sevelamer

 

SCHEDULE 2

Listed Drug Added

Lanthanum

Overview

The National Health Act 1953, as amended by the instrument F2009L01254, introduces specific provisions under subsection 100(1) to establish the Highly Specialised Drugs Program, addressing the need for an adequate supply of special pharmaceutical products for individuals receiving medical treatment in circumstances where the standard Pharmaceutical Benefits Scheme (PBS) is inadequate. This amendment was enacted by the Parliament of Australia to ensure that Australians who are living in isolated areas or those receiving highly specialised treatment in private hospitals can access necessary medications that are not conveniently or efficiently supplied under the general provisions of the PBS. The policy objective is to provide reliable, timely, and affordable access to a wide range of medicines, especially those for highly specialised treatments, thereby improving health outcomes for these individuals.

Scope and Application

The National Health Act 1953, as amended by the instrument F2009L01254, applies to the Pharmaceutical Benefits Scheme (PBS) which ensures Australians have access to a wide range of medicines. This legislation is administered by the Commonwealth and applies to all Australians, including those living in isolated areas or receiving medical treatment in circumstances where the standard PBS provisions are inadequate. The Act allows the Minister to make special arrangements under subsection 100(1) to ensure an adequate supply of special pharmaceutical products for these individuals. The Highly Specialised Drugs Program is an example of such a special arrangement, providing access to highly specialised drugs for non-admitted, day admitted, or discharged private hospital patients. This program is subject to amendments through legislative instruments, as demonstrated by the changes made under PB 120 of 2008, effective from 1 December 2008, and further amended by this instrument to commence on 1 May 2009. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending which drugs should be listed for PBS coverage, considering factors such as clinical effectiveness and cost-effectiveness. The Commonwealth/State Highly Specialised Drugs Working Party assists the PBAC by evaluating the suitability of certain drugs for inclusion in the Highly Specialised Drugs Program.

Key Provisions

The main operative sections of this legislative instrument (F2009L01254) are subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), which provide the authority for the Minister to make special arrangements for providing pharmaceutical benefits to persons in isolated areas or those receiving medical treatment where standard provisions under Part VII of the Act are inadequate. Specifically, subsection 100(1) allows the Minister to establish special arrangements, while subsection 100(2) grants the Minister the power to vary or revoke these arrangements. This instrument amends the previous arrangements (PB 120 of 2008) to include new provisions regarding the Highly Specialised Drugs Program. The Act imposes several obligations on the parties involved. The Pharmaceutical Benefits Advisory Committee (PBAC), established under section 100A, must recommend which drugs and medicinal preparations should be available as pharmaceutical benefits. This recommendation is a prerequisite for the Minister to declare a drug or medicinal preparation under subsection 85(2). Additionally, the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) must evaluate and recommend the suitability of certain drugs for listing under the Highly Specialised Drugs Program. These recommendations must be considered by the PBAC before any drug can be added to the Pharmaceutical Benefits Scheme (PBS). The Act also outlines the consequences for non-compliance. While specific offences and penalties are not detailed in the explanatory statement, breaches of the provisions could potentially lead to civil or criminal penalties under Australian law. The maximum penalties for such breaches, however, depend on the specific nature of the contravention and would be determined by the courts based on the circumstances of each case. It is also important to note that the Act allows for the variation or revocation of special arrangements, which could be considered a form of enforcement against entities that fail to comply with the requirements set forth in the Act. The amendments to the Highly Specialised Drugs Program, as detailed in Schedule 1, introduce Lanthanum as a listed drug and modify the circumstances under which Sevelamer is provided. These changes reflect the ongoing evaluation and adjustment of the program to better meet the needs of patients requiring highly specialised drugs. The amendments ensure that the program remains effective in providing necessary pharmaceutical benefits to those in isolated areas or receiving inadequate medical treatment under standard PBS provisions.

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