Federal Register of Legislation - Australian Government

Primary content

PB 2 of 2011 Arrangements as made
This Arrangement amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (No. PB 116 of 2010) to make a new pharmaceutical benefit available under the Special Arrangement and to make changes to the listings for some currently available pharmaceutical benefits.
Administered by: Health
Registered 31 Jan 2011
Tabling HistoryDate
Tabled HR08-Feb-2011
Tabled Senate08-Feb-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

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. 1)

 

PB 2 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 Arrangements 2010 (PB 116 of 2010) (the Special Arrangement), so as to make a new HSD pharmaceutical benefit available under the Special Arrangement, and to make changes to the listings for some currently available HSD pharmaceutical benefits.  

The medicines 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). 

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 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 February 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.1)

 

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. 1) and that it may also be cited as PB 2 of 2011.

 

Section 2         Commencement

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

 

Section 3         Amendments to PB 116 of 2010

Section 3 provides that Schedule 1 amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Principal Instrument) which was made on 28 November 2010 and commenced on 1 December 2010.  A summary of the changes provided for in Schedule 1 is set out below.

 

Schedule 1

Items 1 – 3 of Schedule 1 amend the Principal Instrument in respect of the new HSD pharmaceutical benefit with the drug azacitidine.

Item 1 includes azacitidine in the definition of CAR drug in section 4 of the Principal Instrument. CAR drugs are subject to additional requirements under the arrangements.

Item 2 amends section 24 of the Principal Instrument to specify the maximum quantity or number of units of azacitidine that that may be directd to be supplied to a patient on any one occasion.

Item 3 amends section 25 of the Principal Instrument to specify the maximum number of repeats of azacitidine that may be prescribed for a patient on any one occasion.

Item 4 changes the brand of a HSD pharmaceutical benefit with the drug apomorphine, by amending the entry in Schedule 1 of the Principal Instrument.

Item 5 inserts the entry for the new HSD pharmaceutical benefit with the drug azacitidine into Schedule 1 of the Principal Instrument.

Item 6 of Schedule 1 changes the responsible person for the HSD pharmaceutical benefit containing the drug Doxorubicin – Pegylated Liposomal, from Schering-Plough Pty Ltd (responsible person code SH) to Janssen-Cilag Pty Ltd (responsible person code JC), by amending Schedule 1 of the Principal Instrument.

Item 7 deletes a brand of HSD pharmaceutical benefit with the drug stavudine.

Item 8 inserts the circumstances which correspond to the ‘circumstances code’ in Schedule 1 for the new HSD pharmaceutical benefit with the drug azacitidine.