EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 12)
PB 111 of 2015
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
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the Act, 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 program.
The amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 111 of 2015 include adding and removing and changes to the circumstances for prescribing various pharmaceutical benefits, and amendments to responsible person codes.
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 and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
Details of the instrument are set out in the Attachment.
This Instrument commences on 1 December 2015.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
Details of the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015
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 2015 (No. 12). It can also be citied as PB 111 of 2015.
Section 2 Commencement
This section provides that this instrument commences on 1 December 2015.
Section 3 Amendment
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Items 1 - 14
Provide for deletions to drugs, forms, brands, and changes to the circumstances for prescribing various pharmaceutical benefits.
These changes are summarised below.
Summary of Changes
Alteration of Circumstances | |
Dornase alfa | Remodelled restrictions |
Everolimus | Remodelled restrictions |
Mannitol | Remodelled restrictions |
Mycophenolic acid | Remodelled restrictions |
Octreotide | Remodelled restrictions |
Sirolimus | Remodelled restrictions |
Tipranavir | Remodelled restrictions |
Zoledronic Acid | Remodelled restrictions |
|
Addition of Brands
Infliximab Inflectra
Zoledronic Acid APO-Zoledronic Acid
DBL Zoledronic Acid
Overview
The National Health Act 1953 was enacted to establish a framework for the provision of health services in Australia, including the regulation of pharmaceutical benefits. The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 12) was introduced to address changes in the highly specialised drugs program, ensuring that the program remains aligned with current medical needs and advancements in pharmaceutical treatments. This amendment instrument was made under the authority of subsections 100(1) and 100(2) of the National Health Act 1953, which allows the Minister to make special arrangements for the supply of pharmaceutical benefits. The policy objective of this instrument is to update the National Health (Highly specialised drugs program) Special Arrangement 2010 to reflect changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, including adjustments to the circumstances for prescribing various pharmaceutical benefits and alterations to responsible person codes. These changes were made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee, an independent expert body that advises the Minister on which drugs should be available as pharmaceutical benefits.
Scope and Application
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 12) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, thereby impacting the highly specialised drugs program within the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. The amendment instrument modifies the circumstances for prescribing certain pharmaceutical benefits, including altering restrictions and adding or removing specific drugs and brands. These changes are aligned with updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The Act applies to pharmaceutical benefits listed under the PBS, and the amendments extend to all entities and individuals involved in the supply and prescription of these drugs across Australia, thereby affecting pharmaceutical companies, healthcare providers, and patients. The legislative instrument commenced on 1 December 2015 and operates under the authority granted by subsections 100(1) and 100(2) of the Act, subject to any special arrangements made under subsection 100(1).
Key Provisions
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2015 (No. 12) (referred to as the Instrument) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (the Special Arrangement) (sections 3(1) and 3(14)). The main changes involve the addition and removal of certain drugs, forms, brands, and adjustments to the prescribing circumstances of various pharmaceutical benefits (section 3(2)-(14)). These changes align with the modifications to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and are detailed in the Attachment to the Instrument. For instance, the Instrument introduces new brands for Infliximab (Inflectra) and Zoledronic Acid (APO-Zoledronic Acid, DBL Zoledronic Acid) and removes certain drugs while altering prescribing restrictions for others.
The Instrument imposes obligations on various parties involved in the highly specialised drugs program. The Minister for Health, as the authority under section 100(1) of the National Health Act 1953, has the power to make special arrangements and amend them as necessary. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in providing recommendations based on clinical effectiveness, safety, and cost-effectiveness of pharmaceutical benefits. Pharmaceutical companies are also required to consult with the PBAC and agree on final listing details. These arrangements ensure that the highly specialised drugs program operates efficiently and effectively.
The Instrument does not explicitly detail specific offences, penalties, or civil/criminal consequences for breaches. However, the underlying National Health Act 1953 contains provisions that could apply. For example, section 100(2) of the Act allows the Minister to vary or revoke a special arrangement if it is deemed necessary. While the Instrument itself does not prescribe penalties, any breaches of the broader legislative framework could result in legal actions under the Act. The specific penalties would depend on the nature and severity of the breach, as governed by other relevant sections of the National Health Act 1953.