EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 5)
PB 43 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 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.
The amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
PB 43 of 2015 involves an amendment to restrictions for the drug omalizumab.
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.
This Instrument commences on 1 May 2015.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Details of the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015
Section 1 Name of Instrument
This section provides that the name of this instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015. It can also be citied as PB 43 of 2015.
Section 2 Commencement
This section provides that this instrument commences on 1 May 2015.
Section 3 Amendment
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
Items 1 and 2 amend the entry in Schedules 1 and 3 of the Special Arrangement by removing circumstance codes ‘C3740’ ‘C3742’and ‘C3822’, purpose codes and the associated circumstances and adding the new circumstance codes ‘C4875’, ‘C4879’, ‘C4880’and ‘C4886’, purpose codes and the associated circumstances for pharmaceutical benefits with the listed drug ‘Omalizumab’.
Overview
The National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015, made under the National Health Act 1953, aims to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 to adjust the highly specialised drugs program for hospitals. This amendment was introduced to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, particularly concerning the drug omalizumab, which is used for the treatment of chronic conditions requiring specialised facilities available in public or private hospitals. The policy objective of this amendment aligns with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established to advise the Minister on the availability of drugs as pharmaceutical benefits. The amendments have been made in consultation with relevant parties, including pharmaceutical companies, ensuring a comprehensive approach to updating the pharmaceutical benefits supplied under the Special Arrangement. The Instrument commences on 1 May 2015.
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2015 amends the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010, modifying the eligibility criteria for the supply of pharmaceutical benefits under the Special Arrangement. This Act applies to the supply of highly specialised drugs, specifically omalizumab, to patients receiving treatment in public or private hospitals with access to appropriate specialised facilities. The amendment reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 and is made pursuant to the authority granted under the National Health Act 1953. This legislative instrument is applicable nationally and is subject to potential variation or revocation by the Minister. It commences on 1 May 2015 and includes consultation processes involving the Pharmaceutical Benefits Advisory Committee and relevant pharmaceutical companies.
Key Provisions
The main operative sections of the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015 (No. 5) (the Instrument) include the amendments to the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (the Special Arrangement) (section 3). This amendment modifies the listing of pharmaceutical benefits for the drug omalizumab, reflecting the changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. Specifically, it replaces certain circumstance codes and purpose codes that previously restricted the use of omalizumab with new codes, thereby altering the eligibility criteria for patients to receive this drug under the program.
The obligations and requirements imposed by this Instrument on the parties and entities it governs primarily involve adherence to the updated listing and conditions for the pharmaceutical benefit of omalizumab. Hospitals, healthcare providers, and patients must now comply with the new circumstance and purpose codes specified in the amended Special Arrangement. This includes ensuring that patients meet the criteria under the new codes for receiving omalizumab as part of the highly specialised drugs program. The Minister for Health, who has the authority to make and vary special arrangements under section 100(1) of the National Health Act 1953, is responsible for overseeing these changes and ensuring that they are implemented effectively. Pharmaceutical companies supplying omalizumab must also ensure their products comply with the new stipulations.
The Instrument does not explicitly state any new offences, penalties, or civil/criminal consequences for breaches of the amended Special Arrangement. However, failure to comply with the provisions of the National Health Act 1953 or the amended Special Arrangement could potentially lead to enforcement actions under the Act. Such actions may include penalties for non-compliance, which are typically outlined in other sections of the Act or related legislation. For instance, under the Health Insurance Act 1973, there are provisions for penalties related to fraudulent claims or misuse of pharmaceutical benefits. Although the Instrument itself does not detail specific penalties, it is part of a broader legislative framework that includes mechanisms for enforcement and compliance.