National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Chemotherapy Pharmaceuticals Access Program (No. PB 5 of 2008)

Overview

The National Health Act 1953, enacted by the Parliament of Australia, provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits through the Australian Pharmaceutical Benefits Scheme (PBS). The Act was amended to establish the Chemotherapy Pharmaceuticals Access Program, which was introduced to address the need for timely and efficient access to chemotherapy pharmaceuticals for patients in public hospitals. This program is implemented under the authority provided by subsection 100(1) of the Act, which allows for special arrangements to ensure adequate supply of special pharmaceutical products for patients in isolated areas or receiving medical treatment where the PBS does not provide sufficient or efficient access. The policy objective is to provide cost-effective and necessary medicines to the Australian community, ensuring that patients requiring chemotherapy have access to these treatments within a clinical setting. The Chemotherapy Pharmaceuticals Access Program is subject to the overarching provisions of Part VII of the Act and is overseen by the Pharmaceutical Benefits Advisory Committee, which makes recommendations to the Minister regarding the availability of pharmaceutical benefits.

Scope and Application

The Chemotherapy Pharmaceuticals Access Program, which is an arrangement under the National Health Act 1953, aims to ensure the supply of chemotherapy pharmaceuticals at public hospitals to non-admitted patients, day admitted patients and patients on discharge. This program falls under the authority of subsection 100(1) of the Act, allowing the Minister to make special arrangements to provide an adequate supply of special pharmaceutical products to persons in certain circumstances. Specifically, the program targets those living in isolated areas or receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under the Act, or where such benefits are inadequate for the treatment. The Act's reach is national, as it involves the Commonwealth's regulation of pharmaceutical benefits, and is implemented through agreements between the Australian Government and participating States. The amendments to the Chemotherapy Pharmaceuticals Access Program, as outlined in Schedule 1 of the legislative instrument, modify the circumstances under which Pemetrexed is provided for the treatment of patients with mesothelioma. This legislative instrument, which commenced on 1 January 2008, amends previous arrangements made under legislative instrument number PB 93 of 2007.

Key Provisions

The main operative sections of the National Health Act 1953 Amendment Special Arrangements Under Subsection 100(1) Chemotherapy Pharmaceuticals Access Program (PB 5 of 2008) establish the framework for the provision of chemotherapy pharmaceuticals to certain patients under specific circumstances. Section 100(1) of the Act allows the Minister to make special arrangements for providing an adequate supply of special pharmaceutical products to individuals who live in isolated areas or are receiving medical treatment where pharmaceutical benefits cannot be conveniently or efficiently supplied under Part VII of the Act or are inadequate for their medical treatment. Section 100(3) clarifies that Part VII of the Act applies subject to any special arrangements made under section 100(1). Schedule 6 of the Act lists drugs and medicinal preparations that may be made available under these special arrangements. The Act imposes specific obligations on the parties involved in the provision of chemotherapy pharmaceuticals under the Chemotherapy Pharmaceuticals Access Program. The Pharmaceutical Benefits Advisory Committee (PBAC) is tasked with making recommendations to the Minister regarding which drugs and medicinal preparations should be available as pharmaceutical benefits. The PBAC is an independent expert body composed of members with relevant qualifications and experience in various fields related to the functions of the PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), the PBAC considers the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments. The Act also outlines the public hospital pharmaceutical reforms that provide Australian Government subsidised access to a range of cancer chemotherapy drugs listed on the PBS for day admitted and non-admitted public hospital patients within a clinical setting. These reforms are implemented through agreements between the Australian Government and participating states, with Victoria, Western Australia, and Queensland currently participating. The reforms aim to ensure that patients in need have timely and reliable access to necessary and cost-effective chemotherapy pharmaceuticals. Under the Act, any breach of the obligations or requirements imposed on the parties could result in civil or criminal consequences. However, the specific offences, penalties, or consequences are not detailed in the explanatory statement. It is likely that any breaches would be subject to the general provisions of the National Health Act 1953 and any relevant state or territory legislation, which may include fines, imprisonment, or other penalties as prescribed by law. The maximum penalties would depend on the specific nature and severity of the breach.