COMMONWEALTH OF AUSTRALIA
National Health Act 1953
PHARMACEUTICAL BENEFITS
DECLARATION UNDER SUBSECTION 85 (2AA)
No. PB 5 of 1999
I, BRETT ANTHONY LENNON, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Aged Care and Delegate of the Minister for Health and Aged Care, 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 shall come into operation on 1 May 1999.
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
Salbutamol
_____________________________________________________________________
Dated this 15th day of April 1999.
BRETT ANTHONY LENNON
Assistant Secretary
Pharmaceutical Benefits Branch
Department of Health and Aged Care
Delegate of the Minister for Health and Aged Care
Overview
The National Health Act 1953 was enacted to provide for the administration of national health programs and to facilitate the coordination of health services across Australia. This legislation was introduced to address the need for a comprehensive framework to manage and regulate the health sector, ensuring that health services are accessible, affordable, and of high quality for all Australians. The Act empowers the Commonwealth to take a leading role in the nation's health system, including the provision of pharmaceutical benefits. The policy objective of the Act is to support a sustainable and efficient health system that meets the evolving needs of the population. The National Health Act 1953 was enacted by the Australian Parliament, reflecting the federal government's commitment to safeguarding public health through coordinated national policies and programs.
Scope and Application
The Pharmaceutical Benefits Declaration under subsection 85 (2AA) of the National Health Act 1953 pertains to the cessation of certain drugs and medicinal preparations from the coverage provided by Part VII of the Act. This legislative instrument applies to the specified drugs and medicinal preparations listed in the Schedule to the Declaration, which in this instance includes Salbutamol. The National Health Act 1953 is a Commonwealth Act, and thus its application extends across the entire nation, affecting entities and individuals involved in the supply, distribution, or use of the specified drugs within Australia. The Declaration is issued by the Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Aged Care, acting as the Delegate of the Minister for Health and Aged Care, and it follows advice from the Pharmaceutical Benefits Advisory Committee. The geographic reach of this Act is nationwide, impacting all relevant parties within the Commonwealth of Australia. The Declaration does not specify any exclusions, exemptions, or thresholds within its text, and the scope of its application is confined to the drugs and preparations listed in the Schedule.
Key Provisions
The key operative sections of the declaration under subsection 85(2AA) of the National Health Act 1953 pertain to the cessation of the application of Part VII of the Act to certain specified drugs and medicinal preparations. Specifically, section 2 of the declaration indicates that the drugs and medicinal preparations listed in the Schedule will no longer be subject to the provisions of Part VII of the National Health Act 1953 (subsection 85(2AA)(2)). This means that Salbutamol, as listed in the Schedule, will no longer be eligible for the benefits provided under Part VII, which typically includes the Pharmaceutical Benefits Scheme (PBS). The declaration came into effect on 1 May 1999, as stated in the document (subsection 85(2AA)(1)).
The declaration imposes an obligation on the relevant parties, including healthcare providers, patients, and pharmaceutical companies, to comply with the changes in the status of Salbutamol as of the effective date. This means that from 1 May 1999, Salbutamol would no longer be considered under the Pharmaceutical Benefits Scheme, affecting the way it is prescribed, supplied, and reimbursed. Healthcare providers must ensure that they are aware of this change and adjust their practices accordingly to avoid any inadvertent non-compliance with the Act.
The legislation does not explicitly detail offences, penalties, or consequences for breach in this particular declaration. However, under the broader scope of the National Health Act 1953, any non-compliance with the Act's provisions could potentially lead to administrative actions, fines, or other legal repercussions depending on the severity and intent of the breach. For example, supplying a drug under the PBS when it is no longer eligible could lead to penalties under the Act. Although specific maximum penalties for this particular declaration are not outlined, general provisions within the Act could apply.
In summary, the declaration under subsection 85(2AA) of the National Health Act 1953 effectively removes Salbutamol from the scope of Part VII, impacting its eligibility for Pharmaceutical Benefits Scheme coverage. Parties involved must ensure compliance with this change, and any failure to do so could result in consequences under the broader provisions of the Act.