National Health Act 1953 - Determination under subsection 85AB(1) - drugs on F1 (No. PB 87 of 2007)

Overview

The Determination — Drugs on F1 (PB 87 of 2007), enacted under subsection 85AB(1) of the National Health Act 1953, was introduced to address the need for a regulatory framework to manage the provision of pharmaceutical benefits to Australian citizens. This legislative instrument, created by the Australian Parliament, aims to ensure that a list of specified drugs is available for subsidised access under the Pharmaceutical Benefits Scheme (PBS). By listing these drugs on the PBS, the legislation aims to improve access to essential medications, thereby enhancing public health outcomes. The determination, which commenced on 1 November 2007, has been periodically updated to reflect changes in medical practices, new drug approvals, and evolving healthcare needs.

Scope and Application

The Determination — Drugs on F1 (PB 87 of 2007), made under subsection 85AB(1) of the National Health Act 1953, commenced on 1 November 2007. This legislative instrument lists specific drugs that are subject to the provisions of the Act, and it applies to entities and individuals involved in the manufacture, supply, or importation of these listed drugs within Australia. The legislation aims to regulate certain drugs by categorising them under Schedule F1, thereby controlling their availability and use under the National Health Act. The scope of this Act extends to Commonwealth jurisdiction, impacting entities and individuals across Australia. There are no stated exclusions or exemptions within the primary text, although the application and enforcement might be subject to further regulations or subordinate instruments that extend or restrict the application of the Act. The Act has been subject to amendments through various legislative instruments, including PB 13, 20, 29, 39, 58, 68, 132 of 2008, PB 5, 15, 37, 51, 78, 99, and 109 of 2009, and PB 7, 17, 38, and 104 of 2010, which have updated the list of drugs on F1 and potentially refined the regulatory framework.

Key Provisions

The Determination - Drugs on F1 (PB 87 of 2007) outlines the inclusion of various drugs on the Pharmaceutical Benefits Scheme (PBS) under the National Health Act 1953. The determination, which commenced on 1 November 2007, lists a range of drugs, each specified by name, that are included on the PBS. This legislative instrument is significant as it provides a legal basis for the inclusion of these drugs on the PBS, which affects their availability, pricing, and reimbursement to patients. The Act imposes several obligations on the parties involved, including the Pharmaceutical Benefits Advisory Committee (PBAC), the Department of Health, and the Pharmaceutical Benefits Scheme (PBS) itself. The PBAC must assess the clinical, economic, and ethical aspects of each drug to determine its suitability for inclusion on the PBS. Once a drug is listed on the PBS, the Department of Health is responsible for ensuring that it is available and accessible to patients, and for managing the financial aspects of the scheme. The PBS itself must provide the listed drugs to patients at a price that is affordable and sustainable, taking into account the costs to the government and the benefits to patients. Failure to comply with the provisions of the Act can result in various civil and criminal penalties. For example, section 101 of the National Health Act 1953 provides for a penalty of up to 50 penalty units (currently AUD 5,300) for each day that a contravention of the Act continues. Additionally, section 102 provides for a penalty of up to 100 penalty units (currently AUD 10,600) for each day that a contravention of the Act continues if the contravention is willful or involves a breach of a condition of registration. These penalties are intended to deter non-compliance and to ensure that the provisions of the Act are upheld. In summary, the Determination - Drugs on F1 (PB 87 of 2007) provides a legal basis for the inclusion of various drugs on the PBS, imposes obligations on the parties involved, and provides for civil and criminal penalties for non-compliance. The Act aims to ensure that the PBS is able to provide affordable and accessible medications to patients, while also ensuring that the scheme is sustainable and financially viable.