National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 10) (PB 93 of 2016)

Administered by Department of Health, Disability and Ageing

Legislation au F2016L01664 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

NATIONAL HEALTH ACT 1953

 

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 10)

 

PB 93 of 2016

 

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.

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) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

Purpose

This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 10) (the Amending Instrument).  The purpose of the Amending Instrument is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) program.

The amendment made by this Instrument reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

The amendments in PB 93 of 2016 include removing a brand, addition of authority requirements, amending a manufacturer code, addition of new pharmaceutical items, removing entries in section 100 only column, changes to circumstances for prescribing and amendments to the General statement for drugs for the treatment of hepatitis C. 

These changes are summarised, by drug name, in the Attachment.

A provision by provision Description of this instrument is contained in the Attachment.

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), 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.

Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS.  This includes consultation through the PBAC process.

Details of the instrument are set out in the Attachment.

This Instrument commences on 1 November 2016.

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


ATTACHMENT

Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016

 

PART 1 PRELIMINARY

Section 1 Name of Instrument
This section provides the name of this instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 10).  It can also be cited as PB 93 of 2016.

 

Section 2 Commencement
This section provides that this instrument commences on 1 November 2016.

 

Section 3 Amendment
This section provides that the Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

 

SCHEDULE

 

Items 1 to7 and Items 9 to 11  Schedules 1 and 3

Items 1 to 7 and Items 9 to 11 provide for removing a brand, addition of authority requirements, amending a manufacturer code, addition of new pharmaceutical items, removing entry in section 100 only column, and changes to circumstances for prescribing.  These changes are summarised below:                             

 

Listed Drug

Type of Change

Azacitidine

Deletion of brand

Etanercept

Addition of authority requirements

Foscarnet

Amended manufacturer code

Lipegfilgrastim

Addition of pharmaceutical item

Paritaprevir with ritonavir with ombitasvir and dasabuvir

Deletion of entry in section 100 only column

Paritaprevir with ritonavir with ombitasvir and dasabuvir and ribavirin

Deletion of entry in section 100 only column

Pegfilgrastim

Remodelled restrictions

Ribavirin

Addition of pharmaceutical item

 

Item 8   Schedule 2

Item 8 amends Schedule 2 of the Special Arrangement to add the new responsible person LM, ‘Link Medical Products Pty Ltd’ to the list of Responsible Person Codes.

 

Item 12   Schedule 3 Part 1

Item 12 amends Schedule 3 Part 1 of the Special Arrangement by adding changes to the treatment regimen for Ribavirin.  It also expands the prescriber restrictions for medicines included in the General statement for the treatment of hepatitis C to include a medical practitioner experienced in the treatment of chronic hepatitis C infection.

 

 

 

 

Overview

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 10) was enacted to amend the National Health (Highly specialised drugs program) Special Arrangement 2010. This instrument was introduced to address gaps and make necessary changes to the Highly Specialised Drugs (HSD) program, ensuring the program remains effective and responsive to new medical developments. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include removing a brand, adding authority requirements, amending a manufacturer code, adding new pharmaceutical items, removing entries in specific columns, and altering prescribing circumstances. The changes were made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits. This amendment instrument commenced on 1 November 2016 and is subject to the Legislation Act 2003.

Scope and Application

The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 10) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, affecting the Highly Specialised Drugs (HSD) program. This legislative instrument applies to pharmaceutical benefits provided under the National Health Act 1953, specifically targeting the Highly Specialised Drugs program. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which include removing certain drug brands, imposing authority requirements for specific drugs, correcting manufacturer codes, adding new pharmaceutical items, and modifying prescribing conditions. The Instrument also includes amendments to the General statement for drugs used in the treatment of hepatitis C, specifying that these drugs must be prescribed by medical practitioners experienced in treating chronic hepatitis C infection. The amendments are effective from 1 November 2016 and are part of a formal consultation process involving the Pharmaceutical Benefits Advisory Committee, which comprises experts from various relevant fields. This Instrument is a legislative instrument under the Legislation Act 2003.

Key Provisions

The main operative sections of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 10) (PB 93 of 2016) include Schedules 1, 2, and 3. These schedules detail the specific amendments made to the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010). Section 1 names the instrument and its citation, while Section 2 specifies the commencement date of 1 November 2016. The Schedules outline changes such as the removal of brands, addition of authority requirements, amendment of manufacturer codes, addition of new pharmaceutical items, and modifications to prescribing circumstances. For instance, under Schedule 1, Item 1 involves the deletion of a brand for Azacitidine, and Item 2 adds authority requirements for Etanercept. Similarly, Schedule 3 includes changes to the treatment regimen for Ribavirin and expands the prescriber restrictions for medicines used in the treatment of hepatitis C to include medical practitioners experienced in treating chronic hepatitis C infection. The obligations imposed by the Amending Instrument on the parties governed by it primarily involve compliance with the updated special arrangement. Pharmaceutical companies and medical practitioners must adhere to the new authority requirements, manufacturer codes, and prescribing conditions outlined in the Schedules. For example, medical practitioners must ensure they meet the expanded criteria for prescribing certain hepatitis C treatments, as specified in Schedule 3. Pharmaceutical companies must update their records and operations to reflect the changes in brand listings and manufacturer codes, as detailed in Schedule 1. Offences and penalties for breach of the Amending Instrument are not explicitly detailed within the text provided. However, general provisions of the National Health Act 1953 (the Act) may apply, where contraventions of the Act or its regulations can lead to criminal and civil penalties. Typically, breaches of the Act may result in fines, imprisonment, or both, depending on the severity of the offence. For example, unauthorised supply of pharmaceutical benefits can lead to substantial fines and imprisonment. The maximum penalties would be as prescribed under the relevant sections of the Act, which could include fines up to several thousand Australian dollars and imprisonment for terms that vary based on the nature and extent of the breach. It is important for parties to ensure compliance to avoid any potential legal repercussions.

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Pharmaceutical Law
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Legislative Instrument
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Repeal & Amendment
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