National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 17 of 1993)

Overview

The National Health Act 1953, enacted by the Parliament of Australia, is the legislative foundation for the administration of the Pharmaceutical Benefits Scheme (PBS), which ensures that Australians have access to affordable and necessary medications. This Act was introduced to address the gap in providing equitable access to essential medicines by establishing a scheme that subsidises the cost of prescription drugs for the Australian public. The Act's policy objective is to make sure that a wide range of necessary medications are accessible and affordable for all Australians, thereby improving public health outcomes. In this context, the Declaration under subsection 85(2AA) of the National Health Act 1953, made by the Assistant Secretary of the Pharmaceutical Benefits Branch, serves to update the list of drugs and medicinal preparations covered by the PBS. The 1993 Declaration, for instance, specifies certain drugs, such as Amoxycillin Sodium, “Maxamum XP”, Rolitetracycline, and Trioxysalen, which were to cease being covered by Part VII of the Act, reflecting adjustments in the scheme's coverage based on expert advice from the Pharmaceutical Benefits Advisory Committee. This mechanism allows for the PBS to be dynamically managed to meet evolving healthcare needs.

Scope and Application

The Pharmaceutical Benefits Declaration under the National Health Act 1953 applies to the cessation of pharmaceutical benefits for specific drugs and medicinal preparations listed in the Schedule of the legislative instrument. The named drugs, including Amoxycillin Sodium, "Maxamum XP," Rolitetracycline, and Trioxysalen, are identified for the removal of their eligibility under Part VII of the National Health Act 1953. This Act operates at the Commonwealth level, affecting all persons and entities within Australia, including patients, healthcare providers, and pharmaceutical companies. The declaration specifies that these drugs will no longer be covered under the Pharmaceutical Benefits Scheme, thereby impacting their reimbursement and accessibility under the national health framework. The exclusion of these specific drugs from the Pharmaceutical Benefits list is effective from 1 December 1993, as per the operational date set out in the declaration. The application of this legislation is precise and does not extend to other drugs not mentioned in the Schedule, ensuring that only the listed preparations are affected by this specific legislative measure.

Key Provisions

The main operative sections of the Declaration under subsection 85 (2AA) of the National Health Act 1953 are found in sections 1 and 2. Section 1 specifies that the Declaration will come into operation on 1 December 1993, marking the date when the changes outlined in the legislation will take effect. Section 2 declares that certain drugs and medicinal preparations, listed in the Schedule, will cease to be subject to Part VII of the National Health Act 1953, effectively removing them from the Pharmaceutical Benefits Scheme (PBS). The Schedule itself lists specific drugs such as Amoxycillin Sodium, “Maxamum XP”, Rolitetracycline, and Trioxysalen. The obligations and requirements imposed by this Act primarily concern the Pharmaceutical Benefits Advisory Committee and the Department of Health, Housing, Local Government and Community Services. According to the Act, the Assistant Secretary, Pharmaceutical Benefits Branch, and Delegate of the Minister for Health, David Trevor Graham, is required to obtain advice from the Pharmaceutical Benefits Advisory Committee before making the declaration. This ensures that the decision to delist certain drugs from the PBS is informed by expert advice. The declaration must also be dated and signed by the Assistant Secretary, confirming his authority and responsibility for the decision. In terms of offences, penalties, or consequences for breach, the Act does not explicitly state penalties for non-compliance with the declaration. However, the removal of drugs from the PBS under Part VII of the National Health Act 1953 could have significant implications for healthcare providers and patients. Providers might need to find alternative treatments or medications, and patients might face higher out-of-pocket costs for the listed drugs. While there are no specific criminal or civil penalties outlined in the Act for breaching the declaration, the administrative and practical consequences of delisting drugs could be substantial.