EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 6 of 2009
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
HIGHLY SPECIALISED DRUGS PROGRAM
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
(a) who are living in isolated areas; or
(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
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) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
The Highly Specialised Drugs Program is a set of Arrangements made under subparagraph 100(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge.
This legislative instrument amends the Arrangements made under subparagraph 100(b)(i) (PB 120 of 2008) which came into effect on 1 December 2008. The amendments are set out in the items of Schedule 1 to the instrument.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 February 2009, was made on 2 January 2009.
Consultations
The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed on the 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.
PBAC members are selected 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) is a non-statutory body established by the Australian Health Ministers Advisory Council (AHMAC). The HSDWP makes recommendations to the PBAC on the suitability of certain drugs for listing under the Highly Specialised Drugs Program. The HSDWP considers the funding and administrative aspects of supply through the hospital system, and a recommendation for listing must be supported by a majority of Working Party members. The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 February 2009.
Paragraph 2: provides that Schedule 1 amends PB 120 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Filgrastim [addition of circumstances for the treatment of a patient receiving first-line chemotherapy for B-cell chronic lymphocytic leukaemia]
Pegfilgrastim [addition of circumstances for the treatment of a patient receiving first-line chemotherapy for B-cell chronic lymphocytic leukaemia]
Overview
The National Health Act 1953, as amended by the instrument F2009L00047, aims to address the issue of providing an adequate supply of highly specialised drugs to patients in isolated areas or undergoing specific treatments where the standard Pharmaceutical Benefits Scheme (PBS) may not be sufficiently convenient or efficient. Enacted by the Parliament of Australia, the policy objective of this amendment is to ensure that patients receiving highly specialised treatments, particularly in private hospitals, have reliable access to necessary medications. This instrument, which came into effect on 1 February 2009, modifies the existing Highly Specialised Drugs Program to include specific treatments for B-cell chronic lymphocytic leukaemia under the administration of Filgrastim and Pegfilgrastim. The changes were recommended by the Commonwealth/State Highly Specialised Drugs Working Party and endorsed by the Pharmaceutical Benefits Advisory Committee, ensuring a balanced consideration of clinical, economic, and administrative factors.
Scope and Application
The National Health Act 1953, as amended, is the legislative foundation of the Pharmaceutical Benefits Scheme (PBS), which ensures that all Australians have reliable, timely, and affordable access to a wide range of medicines. The Act applies to the Commonwealth's provision of pharmaceutical benefits, with drugs and medicinal preparations declared by the Minister under subsection 85(2) to be subject to Part VII of the Act, referred to as listed drugs under subsection 84(1). Special arrangements under subsection 100(1) of the Act are made for providing an adequate supply of special pharmaceutical products to persons living in isolated areas or receiving medical treatment in circumstances where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII, or are inadequate for that medical treatment. These special arrangements are subject to variation or revocation by the Minister under subsection 100(2) and have effect subject to any special arrangement made under subsection 100(1). The Highly Specialised Drugs Program, an arrangement under subsection 100(b)(i) of the Act, ensures the availability of special pharmaceutical products for persons receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients, or patients on discharge. The amendments to the Arrangements made under subparagraph 100(b)(i) (PB 120 of 2008) set out in Schedule 1 of this instrument, which commenced on 1 February 2009, include the addition of circumstances for the treatment of a patient receiving first-line chemotherapy for B-cell chronic lymphocytic leukaemia with respect to Filgrastim and Pegfilgrastim. These amendments were made following recommendations by the Pharmaceutical Benefits Advisory Committee and the Commonwealth/State Highly Specialised Drugs Working Party.
Key Provisions
The primary operative sections of the legislation, F2009L00047, amend the Highly Specialised Drugs Program under the National Health Act 1953. Specifically, section 100(1) allows the Minister to make special arrangements for ensuring the availability of special pharmaceutical products to individuals living in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII or are inadequate. The Act further allows the Minister to vary or revoke these arrangements (subsection 100(2)), and specifies that Part VII operates subject to any such special arrangements (subsection 100(3)). This legislative instrument modifies existing arrangements made in 2008 (PB 120 of 2008) to include new circumstances under which certain drugs can be supplied.
The obligations and requirements imposed by this Act on the parties or entities it governs are primarily centred around the provision of special pharmaceutical products to specific groups. The Minister must ensure that an adequate supply of these products is available under the stipulated conditions. The Pharmaceutical Benefits Advisory Committee (PBAC) plays a crucial role in recommending drugs for inclusion on the Pharmaceutical Benefits Scheme (PBS), ensuring that these drugs meet criteria of clinical effectiveness, safety, and cost-effectiveness. Additionally, the Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) assesses the suitability of drugs for the Highly Specialised Drugs Program, considering both funding and administrative aspects of their supply through the hospital system.
Failure to comply with the provisions of this Act may result in various consequences. While the Act does not explicitly list offences or penalties, breaches of the requirements to provide adequate pharmaceutical supplies or to follow the recommendations of the PBAC and HSDWP could potentially lead to legal action. The Act does not specify maximum penalties, but breaches could result in civil or criminal consequences depending on the severity and intent of the violation. The Minister's authority to vary or revoke special arrangements also underscores the importance of adhering to the stipulated conditions and obligations.
Overall, this legislative instrument is designed to enhance the availability and accessibility of highly specialised drugs for patients who need them, ensuring that the provisions of the National Health Act 1953 are met in a manner that addresses specific medical needs and logistical challenges.