EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2015 (No. 6)
PB 50 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 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 50 of 2015 involves listing of a new drug Anakinra for the treatment of a rare condition, insertion of the name Nevirapine and amendments to restrictions for the drug Ivacaftor.
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 June 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 (No. 6)
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 (No.6). It can also be citied as PB 50 of 2015.
Section 2 Commencement
This section provides that this instrument commences on 1 June 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).
Item 1 and 4 amends the entry in Schedule 1 of the Special Arrangement by adding the new pharmaceutical benefit ‘Anakinra’ for the treatment of moderate to severe cryopyrin associated periodic syndromes.
Item 3 amends the entry in Schedule 3 of the Special Arrangement by medicine named ‘Nevirapine’.
Item 2 and 5 amends the entry in Scheduled 1 and 3 of the Special Arrangement by removing for circumstance codes ‘C4735’ ‘C4743’and ‘C4769’, and adding the new circumstance codes ‘C4904’, ‘C4905’, and ‘C4931’ for pharmaceutical benefits with the listed drug ‘Ivacaftor’.
Overview
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2015 (No. 6) was enacted to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, specifically addressing the supply of pharmaceutical benefits under the highly specialised drugs program for hospitals. This legislative instrument was made under the authority provided by the National Health Act 1953, allowing the Minister to make special arrangements for the supply of pharmaceutical benefits, with the aim of aligning with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The policy objective behind these amendments was to ensure that the highly specialised drugs program reflects current medical advancements and recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established to advise the Minister on which drugs should be available as pharmaceutical benefits. This amendment involved the addition of a new drug, Anakinra, for the treatment of a rare condition, the insertion of Nevirapine, and amendments to restrictions for the drug Ivacaftor. The changes were made in consultation with pharmaceutical companies and were in line with recommendations from the PBAC, ensuring a comprehensive and expert-driven approach to the amendments.
Scope and Application
The National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015 (No. 6) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010, focusing on the supply of highly specialised drugs to hospitals for the treatment of chronic conditions. This Act applies specifically to pharmaceutical benefits supplied under the Special Arrangement, intended for patients receiving treatment at public or private hospitals with access to appropriate specialised facilities. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, such as the addition of a new drug Anakinra for treating a rare condition, the insertion of the name Nevirapine, and amendments to restrictions for the drug Ivacaftor. The geographic reach of this Act is national, operating under the National Health Act 1953, with the Pharmaceutical Benefits Advisory Committee (PBAC) facilitating consultation with various stakeholders, including pharmaceutical companies. This Instrument is effective from 1 June 2015, and it operates within the legislative framework established by the Legislative Instruments Act 2003.
Key Provisions
The National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015 (No. 6) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (F2010L01163). The primary changes include the addition of a new drug, Anakinra, for the treatment of moderate to severe cryopyrin-associated periodic syndromes (Section 3, Item 1 and 4). Additionally, the instrument amends the entry for the drug Nevirapine (Section 3, Item 3) and modifies the circumstances under which the drug Ivacaftor can be supplied, removing certain codes and adding new ones (Section 3, Item 2 and 5). These changes align with updates to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The amendments are effective from 1 June 2015.
The Act imposes specific obligations on the parties involved, including the Minister for Health, who is responsible for making special arrangements for the supply of pharmaceutical benefits under section 100(1) of the National Health Act 1953 (the Act). The Minister must ensure that these special arrangements align with the recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) and take into account the clinical effectiveness, safety, and cost-effectiveness of the drugs. Pharmaceutical companies and healthcare providers must comply with these special arrangements and ensure that the highly specialised drugs are supplied only to eligible patients receiving treatment in hospitals with appropriate specialised facilities. The Act also mandates ongoing consultation with interested parties through the PBAC to ensure that the special arrangements remain current and effective.
Breaches of the provisions under this Act can lead to various civil and criminal consequences. While the specific offences, penalties, or consequences are not detailed in the Explanatory Statement, the Act generally provides for enforcement actions against parties that fail to comply with the special arrangements. This may include administrative penalties, fines, or legal actions to enforce compliance. The Pharmaceutical Benefits Advisory Committee plays a critical role in overseeing the implementation of these special arrangements and ensuring that they meet the required standards for clinical effectiveness and cost-effectiveness. Failure to adhere to these guidelines could result in the revocation or variation of the special arrangement by the Minister, impacting the availability and supply of the listed pharmaceutical benefits.