EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 6)
PB 55 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. 6) (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 55 of 2016 include adding, removing and changing 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 July 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. 6). It can also be cited as PB 55 of 2016.
Section 2 Commencement
This section provides that this instrument commences on 1 July 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 to 14 Schedules 1 and 3
Items 1 to 14 provide for changes to circumstances for prescribing. These changes are summarised below:
Listed Drug | Type of Change |
Darbepoetin alfa; Doxorubicin-pegylated liposomal; Epoetin alfa; Epoetin beta; Epoetin lambda; Interferon gamma-1b; Methoxy polyethylene glycol-epoetin beta. | Remodelled restrictions |
Overview
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 6) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010, which is a legislative instrument made under the National Health Act 1953. This amendment aims to update the Highly Specialised Drugs (HSD) program by aligning it with recent changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The changes include adjustments to the circumstances for prescribing certain drugs, the removal or addition of drugs, and modifications to responsible person codes. These amendments reflect recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the National Health Act to advise the Minister on which drugs should be available as pharmaceutical benefits. The PBAC considers various factors, including the clinical effectiveness, safety, and cost-effectiveness of medicines, and involves consultation with pharmaceutical companies and other stakeholders. The Instrument commenced on 1 July 2016.
Scope and Application
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 6) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 to make changes to the Highly Specialised Drugs (HSD) program. The HSD program provides access to certain highly specialised drugs for patients who do not have access to these drugs through other means, such as the Pharmaceutical Benefits Scheme (PBS). The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on 1 July 2016. The changes include adding, removing, and changing the circumstances for prescribing various pharmaceutical benefits, and amendments to responsible person codes. These changes are summarised, by drug name, in the Attachment. The Instrument applies to the Minister for Health, who is responsible for making special arrangements for the supply of pharmaceutical benefits under the National Health Act 1953. The Instrument does not apply to any other person or entity. The Instrument has a national reach, as it applies to the whole of Australia. There are no stated exclusions, exemptions, or thresholds in the Instrument. The Instrument extends the application of the HSD program by amending the Special Arrangement, which is a subordinate instrument made under the Act.
Key Provisions
The National Health (Highly Specialised Drugs Program) Special Arrangement Amendment Instrument 2016 (No. 6) (PB 55 of 2016) amends the National Health (Highly Specialised Drugs Program) Special Arrangement 2010 (PB 116 of 2010) to update the Highly Specialised Drugs (HSD) program. This involves changes to the circumstances under which certain drugs can be prescribed, including additions, deletions, and modifications (Schedule 1, items 1 to 14). The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The specific changes to each drug are detailed in the attached schedule, providing a comprehensive overview of the updates to the HSD program.
The Act imposes specific obligations on parties involved in the HSD program. Pharmaceutical companies must adhere to the updated prescribing conditions as set out in the amended Special Arrangement. Additionally, prescribers are required to follow the new guidelines and restrictions for the listed drugs to ensure they are used appropriately and cost-effectively. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in these obligations by providing expert advice and recommendations to the Minister, who is responsible for making the final decisions regarding the HSD program. The Minister's role includes reviewing PBAC recommendations and implementing the necessary changes through legislative instruments.
Breach of the provisions outlined in the Amending Instrument can lead to various consequences. Non-compliance with the updated prescribing conditions may result in civil or criminal penalties. The Pharmaceutical Benefits Scheme (PBS) regulations, as well as other relevant health legislation, may impose fines, sanctions, or other legal actions against entities or individuals found to be in breach of the Act. The specific penalties depend on the nature and severity of the breach but can include substantial fines and, in some cases, imprisonment. Ensuring adherence to the amended Special Arrangement is therefore critical to avoid these potential consequences.