National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 15 of 1996)

Overview

The National Health Act 1953, enacted by the Australian Parliament, addresses the provision and regulation of health services, including the Pharmaceutical Benefits Scheme (PBS). The 1996 legislative instrument, F2008B00070, specifically targets the cessation of certain drugs and medicinal preparations from the PBS list. This was achieved through a declaration made by the Assistant Secretary of the Pharmaceutical Benefits Branch, David Trevor Graham, on behalf of the Minister for Health and Family Services, following advice from the Pharmaceutical Benefits Advisory Committee. The policy objective of this instrument was to streamline the PBS by removing drugs that were no longer considered necessary for inclusion, thereby enhancing the efficiency and focus of the scheme on medications that provide the greatest benefit to the community. The Declaration resulted in the specified drugs and preparations no longer being subject to the provisions of Part VII of the National Health Act 1953, effective from 1 November 1996.

Scope and Application

The Pharmaceutical Benefits Declaration under subsection 85 (2AA) of the National Health Act 1953 applies to the specified drugs and medicinal preparations listed in the Schedule, which are no longer considered eligible for the Pharmaceutical Benefits Scheme. The Act operates at the Commonwealth level, impacting entities and individuals who supply or administer these pharmaceuticals within Australia. This legislative instrument effectively removes certain drugs from the scope of the Pharmaceutical Benefits Scheme, thereby influencing the healthcare sector by altering the types of medications that are subsidised by the Australian Government. The exclusion of these drugs from the Scheme means that they will no longer receive the financial assistance provided under Part VII of the National Health Act 1953. This legislative measure, which came into operation on 1 November 1996, is made by the Assistant Secretary of the Pharmaceutical Benefits Branch, acting as the delegate of the Minister for Health and Family Services, following advice from the Pharmaceutical Benefits Advisory Committee.

Key Provisions

The main operative sections of the Declaration under subsection 85(2AA) of the National Health Act 1953 specify that certain drugs and medicinal preparations will cease to be covered by Part VII of the Act. Specifically, the Declaration (subsection 2) identifies the drugs and medicinal preparations that will no longer be subject to the provisions of Part VII, which relates to the Pharmaceutical Benefits Scheme. The drugs and preparations listed include Calcium Carbonate with Calcium Lactate-Gluconate, Chloramphenicol with Polymyxin B Sulfate, Gas-gangrene Antitoxin, Mixed, Menotrophin, Oestrone, and Protamine Sulfate. The Declaration imposes obligations on the entities governed by the Act by removing certain drugs and medicinal preparations from the scope of Part VII. This means that these specified drugs will no longer be eligible for the benefits provided under the Pharmaceutical Benefits Scheme. The Pharmaceutical Benefits Advisory Committee has provided advice to the Assistant Secretary, who then makes the Declaration on behalf of the Minister for Health and Family Services. This process ensures that the changes are made with due consideration of the implications for the healthcare system and the public. There are no explicit offences, penalties, or civil/criminal consequences stated in this Declaration itself. However, the removal of these drugs from the Pharmaceutical Benefits Scheme may have significant implications for healthcare providers, patients, and pharmaceutical companies. For example, healthcare providers may need to adjust their billing practices, and patients may need to seek alternative treatments or pay out-of-pocket costs for these medications. The Declaration does not directly impose penalties for non-compliance, but any resulting actions taken by healthcare providers or patients in response to the changes could potentially lead to legal consequences under other provisions of the National Health Act 1953 or related legislation.