COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85 (2AA)
No. PB 7 of 1996
I, ALAN WILLIAM STEVENS, Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Family Services and Delegate of the Minister for Health and Family Services, 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:
1. This Declaration shall come into operation on 1 May 1996.
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
Adrenaline
Dated this seventeenth day of April 1996.
A. STEVENS
Acting Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Family Services
Delegate of the Minister for Health and Family Services
Overview
The National Health Act 1953 was enacted to establish a framework for the provision of health services in Australia, including the regulation of pharmaceutical benefits. This piece of legislation aimed to address the need for a coordinated national approach to the provision of healthcare services, ensuring that Australians have access to essential medical treatments and medications. The Act was enacted by the Commonwealth Parliament to provide a legislative foundation for the administration of health services across the nation. The policy objective behind this legislation was to create a consistent and equitable system for the delivery of healthcare, including the regulation of pharmaceutical benefits, to ensure that all Australians have access to necessary health services.
This particular legislative instrument, F2008B00068, is a declaration made under subsection 85 (2AA) of the National Health Act 1953. It was introduced to specify that certain drugs and medicinal preparations would cease to be subject to the provisions of Part VII of the Act. This decision was made by the Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Family Services, who acted as the delegate of the Minister for Health and Family Services. The declaration came into operation on 1 May 1996, as per the instrument, and involved the cessation of certain drugs and medicinal preparations from the scope of the Pharmaceutical Benefits Scheme.
Scope and Application
The National Health Act 1953, specifically the Declaration under subsection 85 (2AA) made by the Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Family Services, pertains to the cessation of certain drugs and medicinal preparations from being subject to Part VII of the Act. This legislative instrument applies to the drugs and medicinal preparations listed in the Schedule, which in this instance includes Adrenaline. The Declaration operates within the Commonwealth jurisdiction, impacting entities and individuals involved in the pharmaceutical benefits scheme under the Act. Notably, the Declaration removes the specified drugs from the purview of Part VII of the Act, thereby altering their status and potentially affecting their reimbursement and availability under the Pharmaceutical Benefits Scheme. This amendment reflects the decisions made by the Pharmaceutical Benefits Advisory Committee, as advised to the Acting Assistant Secretary. The Declaration is effective from 1 May 1996, marking a definitive change in the legislative application to the listed drugs.
Key Provisions
The Declaration under subsection 85 (2AA) of the National Health Act 1953 (section 1) specifies that certain drugs and medicinal preparations will no longer be subject to Part VII of the Act. This change will take effect from 1 May 1996, as outlined in section 2 of the Declaration. The drugs and preparations that are specifically removed from the scope of Part VII are detailed in the Schedule attached to the Declaration. For instance, Adrenaline is listed in the Schedule, indicating that it will no longer be subject to the provisions of Part VII of the Act.
The obligations and requirements imposed by this Declaration are primarily administrative. The Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Family Services, acting as the Delegate of the Minister for Health and Family Services, must ensure that the Declaration is made in accordance with the Act. This involves obtaining advice from the Pharmaceutical Benefits Advisory Committee as required by subsection 85 (2AB) of the National Health Act 1953 (subsection 85 (2AA)). The Declaration itself serves to notify the public and relevant stakeholders that the specified drugs and medicinal preparations are no longer covered under Part VII of the Act from the effective date.
Breach of the provisions in the National Health Act 1953, including those related to the Declaration, could result in various legal consequences. For instance, individuals or entities that contravene the provisions of Part VII after the effective date of the Declaration may face penalties. Although the specific penalties are not detailed in the Declaration, they are typically outlined in other sections of the National Health Act 1953. The penalties for such breaches can vary widely depending on the nature and severity of the offence, potentially including fines, imprisonment, or both. The maximum penalties are stipulated elsewhere in the Act and can be significant, reflecting the importance of compliance with national health regulations.