National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 5 of 2003)

Overview

The National Health Act 1953, enacted by the Australian Parliament, primarily aims to establish and maintain the Pharmaceutical Benefits Scheme (PBS), which provides subsidised access to essential medications for Australians. This legislative instrument, specifically the "Declaration Under Subsection 85(2AA)" issued in 2003, addresses the need to periodically review and update the list of drugs and medicinal preparations covered under the PBS. The instrument, made by Joan Corbett as the Delegate of the Minister for Health and Ageing, aims to ensure that the PBS remains aligned with contemporary medical needs and economic considerations. By removing certain drugs and medicinal preparations from the PBS, the policy objective is to rationalise the scheme and focus resources on treatments that offer the greatest benefit to the population. This continuous updating process ensures that the PBS remains a sustainable and effective system for providing necessary medications to Australians.

Scope and Application

The Pharmaceutical Benefits Declaration under subsection 85(2AA) of the National Health Act 1953 applies to the drugs and medicinal preparations specified in the Schedule of the legislative instrument, which in this instance are Bumetanide and Urofollitrophin. This legislative instrument, made by the Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Health and Ageing, and acting as the delegate of the Minister for Health and Ageing, effectively removes these specific drugs from the list of substances covered under Part VII of the National Health Act 1953, which pertains to the Pharmaceutical Benefits Scheme. The Declaration applies from 1 May 2003 and has a national jurisdictional reach, impacting all entities and persons subject to the Pharmaceutical Benefits Scheme across Australia. The legislation does not specify exclusions, exemptions, or thresholds beyond the listed drugs and does not extend or restrict its application through subordinate instruments.

Key Provisions

The key provisions of the Pharmaceutical Benefits Declaration under subsection 85(2AA) of the National Health Act 1953, made by Joan Corbett on 10 April 2003, commence on 1 May 2003 and specify that the listed drugs and medicinal preparations, namely Bumetanide and Urofollitrophin, will cease to be covered under Part VII of the National Health Act 1953. This means that these drugs will no longer be eligible for subsidies or benefits under the Pharmaceutical Benefits Scheme (PBS) as of the commencement date. The decision to remove these drugs from the PBS is based on advice from the Pharmaceutical Benefits Advisory Committee, as required by subsection 85(2AB) of the Act. Entities and individuals subject to the Act, such as pharmaceutical companies, healthcare providers, and patients, are required to comply with this declaration by recognising that Bumetanide and Urofollitrophin will no longer be covered by the PBS from the effective date. This change will impact the availability and cost of these medications, as they will no longer be subsidised by the Commonwealth. Healthcare providers and patients must therefore adjust their practices and budgets accordingly. Failure to comply with this declaration may result in civil or criminal consequences. While specific penalties are not outlined in the legislation, breaches of the National Health Act 1953 could lead to fines or other legal actions under the general provisions of the Act. For example, subsection 13UD of the Act imposes penalties for misleading or deceptive conduct in relation to pharmaceutical benefits, and subsection 13UF provides for penalties for dishonestly obtaining benefits. The maximum penalties for these offences can include substantial fines and, in some cases, imprisonment, depending on the nature and severity of the breach. Therefore, all parties must ensure adherence to the declared changes to avoid any potential legal repercussions.