EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 2)
PB 16 of 2011
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (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.
Section 100 special arrangements and Part VII of the Act
Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:
(a) who are living in isolated areas: or
(b) who are receiving treatment in circumstances in which generally available pharmaceutical benefits are inadequate for that treatment; or
(c) if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the arrangements.
Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1). A section 100 arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments.
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).
Changes to the Special Arrangement made by this Instrument
This instrument amends the definition of Complex Authority Required (CAR) drugs to alphabetise the list of CAR drugs contained within. There are no changes to which drugs are considered to be CAR drugs.
This instrument also provides for circumstances in which a prescription for the supply of pharmaceutical benefits with the listed drug Azacitidine may be written. These amendments accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
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 PBS, 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 prescribing circumstances for listings on the PBS and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
General
This Instrument commences on 1 March 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2011 (No. 2) was enacted to amend the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement 2010. This amendment was introduced under the authority of subsections 100(1) and 100(2) of the National Health Act 1953, empowering the Minister for Health and Ageing to make special arrangements for ensuring an adequate supply of pharmaceutical benefits to specific groups, including those receiving treatment in circumstances where generally available benefits are inadequate. The primary policy objective of this legislative instrument is to align the highly specialised drugs program with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), ensuring that treatments for chronic conditions, requiring specialised facilities, are adequately provided. The amendments include alphabetising the list of drugs requiring a Complex Authority Required (CAR) without altering the list of CAR drugs themselves, and providing specific circumstances for the prescription of the drug Azacitidine, in line with PBAC recommendations. The instrument reflects an ongoing consultation process involving PBAC and relevant stakeholders, ensuring that the changes are well-informed and reflect expert medical advice.
Scope and Application
The National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2011 (No. 2) amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 under the authority of the National Health Act 1953. This legislative instrument applies to highly specialised drugs supplied to patients receiving treatment in public or private hospitals with access to appropriate specialised facilities, particularly for chronic conditions where generally available pharmaceutical benefits are inadequate. The changes involve alphabetising the list of Complex Authority Required (CAR) drugs without altering which drugs are considered CAR drugs, and providing specific circumstances for the prescription of the drug Azacitidine. The amendments align with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under the Act to advise on which drugs should be available as pharmaceutical benefits. The instrument’s amendments are effective from 1 March 2011 and are subject to the provisions of the Legislative Instruments Act 2003.
Key Provisions
The main operative sections of this legislation, the National Health (Highly Specialised Drugs Program for Hospitals) Special Arrangement Amendment Instrument 2011 (No. 2), pertain to changes in the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (section 100(1)). This amendment instrument modifies the definition of Complex Authority Required (CAR) drugs by alphabetising the list of CAR drugs but does not alter which drugs are considered CAR drugs (subsection 100(1)). Additionally, it provides for the circumstances in which a prescription for the supply of pharmaceutical benefits with the listed drug Azacitidine may be written, aligning with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) (subsection 100(2)).
The obligations imposed by this legislation on parties and entities include adherence to the modified definition of CAR drugs and the new prescribing circumstances for Azacitidine. These changes require healthcare providers and pharmaceutical companies to align with the new specifications outlined in the amended special arrangement. Furthermore, these entities must ensure that their practices comply with the recommendations of the PBAC and the requirements set out in the National Health Act 1953. Such compliance ensures that the pharmaceutical benefits provided remain appropriate for the treatment of chronic conditions requiring specialised facilities and care.
Failure to comply with the provisions of this Act can lead to several consequences. While the document does not explicitly detail the specific offences or penalties, breaches of the National Health Act 1953 can result in both civil and criminal liabilities. The penalties for non-compliance could include fines, imprisonment, or both, depending on the severity of the breach. The exact penalties would be determined based on the relevant sections of the Act and any additional regulations or instruments made under it. It is crucial for all parties involved to understand and adhere to the stipulations to avoid any legal repercussions.