EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 127 OF 2009
NATIONAL HEALTH ACT 1953
AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)
SPECIAL AUTHORITY PROGRAM (TRASTUZUMAB)
Purpose and operation
The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
Subsection 85(1) of the Act provides that benefits shall be provided by the Commonwealth in accordance with Part VII of the Act in respect of pharmaceutical benefits.
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 Special Authority Program (Trastuzumab) is a set of Arrangements made under subparagraph 100(1)(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who require treatment with trastuzumab.
This legislative instrument amends the Arrangements made under subparagraph 100(b)(i) (PB 56 of 2009) which came into effect on 1 July 2009. The amendments are set out in the items of Schedule 1 to the instrument.
These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 January 2010, was made on
11 December 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.
ATTACHMENT
Paragraph 1 provides that this instrument commences on 1 January 2010.
Paragraph 2 provides that Schedule 1 amends PB 56 of 2009.
Schedule 1 provides for the following amendments:
Item 1 amends paragraph 20 to refer to the Highly Specialised Drugs Program Arrangements for Public Hospitals 2010 (PB 125 of 2009) (the 2010 HSD arrangements), commencing 1 January 2010, rather than the Highly Specialised Drugs Program Arrangements for Public Hospitals 2009 (PB 61 of 2009) which were revoked by the 2010 HSD arrangements. The effect is to clarify that for the purposes of paragraph 19, the dispensed price is to be ascertained in accordance with paragraphs 33 to 35 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in No. PB 125 of 2009 as if those arrangements applied to trastuzumab.
Item 2 omits paragraph 22(c), in relation to the online incentive fee for public hospital authorities. This paragraph has been removed because the online incentive payment is in fact payable under administrative, rather than legislative, arrangements in accordance with the Fourth Community Pharmacy Agreement (the Agreement). Accordingly, reference to the fee in the Arrangements is unnecessary. The omission of this paragraph does not affect any person’s entitlement to receive the fee under the Agreement.
Overview
The National Health Act 1953 was enacted to provide a legislative framework for the administration of the Australian Pharmaceutical Benefits Scheme (PBS), ensuring timely, reliable and affordable access to necessary and cost-effective medicines for the Australian community. This Act empowers the Minister to make special arrangements under subsection 100(1) for the supply of special pharmaceutical products to individuals in isolated areas or those undergoing medical treatment where conventional pharmaceutical benefits under Part VII of the Act are either inefficiently supplied or inadequate. The policy objective behind these provisions is to ensure that all Australians, regardless of their geographical location or specific medical needs, have access to essential medications. The Parliament of Australia enacted this Act, and the explanatory statement for the instrument F2009L04639 clarifies the operation of special arrangements for the provision of trastuzumab, a drug used in the treatment of certain cancers, under the Special Authority Program. This legislative instrument amends previous arrangements to align with the Highly Specialised Drugs Program Arrangements for Public Hospitals 2010, ensuring that the dispensed price for trastuzumab is consistent with the prices set for other highly specialised drugs.
Scope and Application
The National Health Act 1953, as amended by the instrument F2009L04639, applies to individuals and entities involved in the supply of pharmaceutical benefits within Australia, with a particular focus on the Special Authority Program for trastuzumab. This legislation ensures that Australians, particularly those in isolated areas or undergoing specialised medical treatments, have access to necessary medications. The Act provides for special arrangements under subsection 100(1) that allow for the provision of special pharmaceutical products where standard arrangements under Part VII of the Act are inadequate. The amendments to the Special Authority Program, effective from 1 January 2010, clarify the pricing arrangements for highly specialised drugs, referencing the Highly Specialised Drugs Program Arrangements for Public Hospitals 2010. Additionally, the amendments remove outdated references to an online incentive fee for public hospital authorities, reflecting that such fees are governed by administrative arrangements under the Fourth Community Pharmacy Agreement. The Act's provisions are subject to variations or revocations by the Minister under subsection 100(2), and its scope is further defined by the declaration under subsection 85(2) which lists drugs available under the special arrangements.
Key Provisions
The key operative sections of this legislation are subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), which allow the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to persons who are living in isolated areas or are receiving medical treatment in circumstances where pharmaceutical benefits under Part VII of the Act are inadequate or cannot be supplied efficiently. The legislation specifically amends the Arrangements made under subparagraph 100(1)(b)(i) of the Act for the Special Authority Program (Trastuzumab), which came into effect on 1 July 2009. The amendments clarify the referencing to the Highly Specialised Drugs Program Arrangements for Public Hospitals 2010 and remove the reference to the online incentive fee for public hospital authorities, as this fee is payable under administrative arrangements in accordance with the Fourth Community Pharmacy Agreement.
The Act imposes specific obligations on the parties involved in the Special Authority Program (Trastuzumab). The Minister is responsible for making the special arrangements for the supply of trastuzumab and ensuring that adequate supplies are available to those who need it. The Pharmaceutical Benefits Advisory Committee (PBAC) must recommend that trastuzumab be made available as a pharmaceutical benefit, taking into account its medical conditions, clinical effectiveness, safety, and cost-effectiveness compared to other treatments. Public hospitals and other entities involved in the supply and administration of trastuzumab must comply with the special arrangements and any related guidelines or requirements.
The legislation includes provisions for offences, penalties, and consequences for breaches. While the Explanatory Statement does not detail specific offences or penalties, breaches of the special arrangements or related guidelines could potentially result in civil or criminal consequences. The maximum penalties for offences under the National Health Act 1953 can include fines and imprisonment, depending on the nature and severity of the offence. The specific penalties would be determined by the relevant courts based on the circumstances of each case.
In summary, the main provisions of this legislation relate to the special arrangements for providing trastuzumab under the Australian Pharmaceutical Benefits Scheme. The Minister has the authority to make these arrangements, and the PBAC must recommend the inclusion of trastuzumab as a pharmaceutical benefit. Parties involved in the supply and administration of trastuzumab must comply with the special arrangements. Breaches of these arrangements or related guidelines could result in civil or criminal consequences, with penalties determined by the relevant courts.