COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85 (2AA)
No. PB 5 of 2002
I, BRETT ANTHONY LENNON, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and Delegate of the Minister for Health and Ageing, having in accordance with subsection 85 (2AB) of the National Health Act 1953 obtained the advice of the Pharmaceutical Benefits Advisory Committee, pursuant to subsection 85 (2AA) of the National Health Act 1953, hereby make the following Declaration:
- This Declaration commences on 1 May 2002.
2. The drugs and medicinal preparations specified in the Schedule to this Declaration shall cease to be drugs and medicinal preparations to which Part VII of the National Health Act 1953 applies.
THE SCHEDULE
Disopyramide Phosphate
Omeprazole Magnesium and Metronidazole and Amoxycillin Trihydrate
Probucol
Sulfinpyrazone
Dated this 8th day of April 2002.
BRETT ANTHONY LENNON
Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
Overview
The National Health Act 1953 was enacted by the Parliament of Australia to establish the framework for the provision of health services and the regulation of pharmaceutical benefits within the country. The Act was introduced to address the need for a coordinated and efficient system for delivering healthcare and ensuring the availability of necessary medications to the public. One of the key mechanisms established by the Act is the Pharmaceutical Benefits Scheme (PBS), which provides subsidised access to a wide range of medications. The policy objective of the Act is to ensure that essential medicines are accessible and affordable to all Australians, thereby promoting public health and well-being. In this context, the Pharmaceutical Benefits Declaration under subsection 85(2AA) serves to update the list of drugs and medicinal preparations covered by the PBS, reflecting changes in medical practices, new scientific evidence, and economic considerations. This legislative instrument, issued by the Minister for Health and Ageing, aims to maintain the effectiveness and relevance of the PBS in meeting the health needs of the Australian population.
Scope and Application
The Pharmaceutical Benefits Declaration under subsection 85 (2AA) of the National Health Act 1953 applies specifically to the cessation of the inclusion of certain drugs and medicinal preparations from the Pharmaceutical Benefits Scheme (PBS). The named drugs and medicinal preparations, as specified in the Schedule to the Declaration, will no longer be covered under Part VII of the Act. This cessation impacts the eligibility of these specific drugs for government subsidies, which in turn affects the pharmaceutical industry and consumers. The geographic reach of this Act is national, as it applies throughout the Commonwealth of Australia. The Act does not specify any exclusions or exemptions, nor does it set any thresholds for application, as it directly addresses the named drugs listed in the Schedule. The application of the Act is extended through subordinate instruments such as the Schedule, which lists the specific drugs affected by the Declaration.
Key Provisions
The main operative sections of this legislative instrument are found under subsection 85 (2AA) of the National Health Act 1953, which allows for the cessation of certain drugs and medicinal preparations from being subject to Part VII of the Act. This is achieved through the Declaration made by Brett Anthony Lennon, Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Health and Ageing, and Delegate of the Minister for Health and Ageing (subsection 85(2AB)). The Declaration specifies the drugs and medicinal preparations that will cease to be covered under Part VII, as listed in the attached Schedule. This legislative instrument came into effect on 1 May 2002, as indicated in the text.
The obligations and requirements imposed by this Act pertain primarily to the Department of Health and Ageing, and Brett Anthony Lennon, in his capacity as the Delegate of the Minister for Health and Ageing. Under subsection 85 (2AA), the Assistant Secretary must obtain advice from the Pharmaceutical Benefits Advisory Committee before making a Declaration under this Act. Once the advice is obtained, the Assistant Secretary, as the Delegate, must make a formal Declaration, specifying the drugs and medicinal preparations that will no longer be covered by Part VII of the National Health Act 1953. The Schedule, which lists the affected drugs and preparations, must also be included in the Declaration.
Any breach of the obligations and requirements set forth in this legislative instrument may lead to legal consequences. Although the specific offences, penalties, or civil/criminal consequences are not detailed in the provided text, it is likely that failure to comply with the obligations set forth in the Act could result in fines, legal action, or other penalties as prescribed by the National Health Act 1953. The maximum penalties for such breaches would depend on the specific provisions of the Act and the nature of the breach. It is essential for parties and entities governed by this Act to adhere to its requirements to avoid any potential legal consequences.