National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 9) (No. PB 69 of 2011)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L01978 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Issued by Authority of the Minister for Health and Ageing

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 9)

 

PB 69 of 2011

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving treatment at or from a public or private hospital having access to appropriate specialised facilities.

Section 100 special arrangements and Part VII of the Act

Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:

(a)  who are living in isolated areas: or

(b) who are receiving treatment in circumstances in which generally available pharmaceutical benefits  are inadequate for that treatment; or

(c) if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.

Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).  A section 100 arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments.

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

Changes to the Special Arrangement made by this Instrument

This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the Highly specialised drugs program for hospitals. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commences on the same day.

This instrument:

  • omits five pharmaceutical benefits; and
  • changes the responsible person code for a pharmaceutical benefit.

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). 

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.  PBAC is an independent expert body established by section 100A of the Act 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), 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.

Pharmaceutical companies were consulted throughout the process of changes to the prescribing circumstances for listings on the PBS and for this Instrument.  This includes consultation through the PBAC process, and agreement to final listing details.

General

This Instrument commences on 1 October 2011.

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

A provision by provision description of this Instrument is contained in the Attachment.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ATTACHMENT

 

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No.9)

 

Section 1 Name of Instrument

This section provides that this Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No.9) and that it may also be cited as PB 69 of 2011.

Section 2 Commencement

This section provides that this Instrument commences on 1 October 2011.

Section 3 Amendments to PB 116 of 2010

This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Principal Instrument).             

Schedule 1

Item 1 amends Schedule 1 by changing the Responsible Person Code from ‘SC’ (Bayer Australia Ltd) to ‘BN’ (Bayer Australia Ltd) for the pharmaceutical benefit Iloprost in the form Solution for inhalation 20 micrograms (as trometamol) in 2 mL with manner of administration Inhalation and brand Ventavis.  

Item 2 amends Schedule 1 by removing 5 pharmaceutical benefits with the listed drug Ribavirin with Peginterferon Alfa‑2b, manner of administration Injection/oral, and brand Pegatron, and the forms:

  • Pack containing 84 capsules ribavirin 200mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent
  • Pack containing 168 capsules ribavirin 200mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
  • Pack containing 84 capsules ribavirin 200mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent
  • Pack containing 84 capsules ribavirin 200mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent
  • Pack containing 84 capsules ribavirin 200mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent

Items 3 and 4 amend Schedule 2 of the Special Arrangement by changing the Responsible Person Code for the Responsible Person Bayer Australia Ltd from ‘SC’ to ‘BN’.

 

Overview

The National Health Act 1953, through the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 9), amends the special arrangement for the provision of highly specialised drugs for hospitals. This legislative instrument addresses the need to update the pharmaceutical benefits available under the special arrangement to ensure an adequate supply of pharmaceutical benefits for patients in isolated areas or receiving treatment in circumstances where generally available pharmaceutical benefits are inadequate. Enacted by the Parliament of Australia, this amendment is intended to align the special arrangement with the most recent recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and to ensure that the drugs listed are those that are clinically effective, safe, and cost-effective. The changes reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument, which include the omission of five pharmaceutical benefits and a change in the responsible person code for a specific pharmaceutical benefit. The amendment was developed following consultations with PBAC and pharmaceutical companies to ensure the recommendations are both appropriate and acceptable to all stakeholders.

Scope and Application

The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2011 (No. 9) amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, which provides for the supply of highly specialised pharmaceutical benefits to patients in hospitals. This legislative instrument applies to the treatment of chronic conditions requiring specialised facilities, which are often inadequately served by generally available pharmaceutical benefits. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument, resulting in the removal of five pharmaceutical benefits related to Ribavirin with Peginterferon Alfa-2b and a change in the responsible person code for the pharmaceutical benefit Iloprost. The amendments are made under subsections 100(1) and 100(2) of the National Health Act 1953, allowing the Minister to make special arrangements for providing pharmaceutical benefits. This special arrangement applies nationally and is subject to modification by the Minister. The instrument commenced on 1 October 2011, and the amendments were made in consultation with the Pharmaceutical Benefits Advisory Committee, which includes representatives from various healthcare sectors, ensuring a balanced consideration of the changes.

Key Provisions

The main operative sections of this legislative instrument, specifically the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 9), focus on making amendments to the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010). Section 3 of the Instrument details the amendments to Schedule 1 of the Special Arrangement, which include changing the responsible person code for a particular pharmaceutical benefit and omitting five pharmaceutical benefits (subsections 100(1) and 100(2)). The changes are intended to reflect updates to the National Health (Listing of Pharmaceutical Benefits) Instrument and are made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The obligations imposed by the Act on the parties or entities it governs include the requirement to ensure that an adequate supply of pharmaceutical benefits is available to specific groups, such as individuals in isolated areas or those receiving treatment in circumstances where generally available pharmaceutical benefits are inadequate. Under subsection 100(1), the Minister can make special arrangements for providing these benefits. The Pharmaceutical Benefits Advisory Committee plays a crucial role in advising the Minister on which drugs should be available as pharmaceutical benefits, taking into account clinical effectiveness, safety, and cost-effectiveness. The ongoing consultation process with PBAC and pharmaceutical companies ensures that the changes to the Special Arrangement are well-informed and agreed upon by relevant stakeholders. In terms of consequences for breaches, the Act does not explicitly outline specific offences, penalties, or civil/criminal consequences for non-compliance with the special arrangement. However, the legislative framework under which the special arrangement operates, particularly under subsection 100(2), provides the Minister with the authority to vary or revoke the arrangement if necessary. This authority ensures that the special arrangement remains effective and aligned with the intended purpose of providing adequate pharmaceutical benefits to those in need. The legislative instrument, being a legislative instrument for the purposes of the Legislative Instruments Act 2003, ensures that the changes are implemented in a structured and formal manner, providing a clear legal basis for the amendments made to the Special Arrangement.

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