National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 19 of 1998)

Overview

The National Health Act 1953, enacted by the Parliament of Australia, established a framework for health services and benefits across the country. One of the key provisions of this Act, particularly relevant to the pharmaceutical sector, is the Pharmaceutical Benefits Scheme (PBS), which provides financial assistance for prescription medications. The legislation was introduced to address the need for a structured system to manage the costs and availability of essential medications for the Australian public. The Pharmaceutical Benefits Declaration under subsection 85(2AA) of the National Health Act 1953 was made to manage the list of approved drugs and medicinal preparations by removing certain substances from the PBS. This particular declaration, issued by Alan William Stevens on behalf of the Minister for Health and Family Services, was intended to ensure that the scheme remained effective and targeted by excluding specific drugs deemed no longer necessary for inclusion. This action reflects the policy objective of maintaining a streamlined and efficient PBS.

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 include Aluminium Hydroxide, Dried with Light Kaolin or Light Kaolin (Natural), Aminophylline, Calcitonin (Human) – Synthetic, and Methdilazine Hydrochloride Orphenadrine Hydrochloride. This legislative instrument affects entities and individuals involved in the supply and administration of these pharmaceuticals by removing their eligibility for the Pharmaceutical Benefits Scheme (PBS) under Part VII of the National Health Act 1953. The removal of these drugs from the PBS impacts suppliers, healthcare providers, and consumers who rely on these medications for treatment. The Declaration is operative on 1 November 1998, and it applies across the Commonwealth of Australia, impacting the national healthcare system. This legislative instrument does not exclude any specific persons or entities, but its effect is limited to the drugs listed in the Schedule. The scope of the Act can be extended or modified through subordinate instruments issued under the authority of the National Health Act 1953.

Key Provisions

The Declaration under Subsection 85 (2AA) of the National Health Act 1953 (Section 2) specifies that certain drugs and medicinal preparations will cease to be covered by Part VII of the Act. The drugs listed in the Schedule to this Declaration, which includes Aluminium Hydroxide, Dried with Light Kaolin or Light Kaolin (Natural), Aminophylline, Calcitonin (Human) – Synthetic, Methdilazine Hydrochloride, and Orphenadrine Hydrochloride, will no longer be subject to the provisions of the Pharmaceutical Benefits Scheme as of 1 November 1998. This cessation of coverage means that these medications will no longer be eligible for the benefits provided under the scheme, such as subsidies for the cost of the drugs. The Act imposes certain obligations and requirements on the entities and individuals it governs. The Acting Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Family Services, as the Delegate of the Minister for Health and Family Services, is required to obtain the advice of the Pharmaceutical Benefits Advisory Committee before making such a declaration. This ensures that the decision to remove these drugs from the Pharmaceutical Benefits Scheme is based on thorough consideration and expert advice. Additionally, the declaration itself must be made in accordance with the provisions of the Act, and the specified date of operation for the changes must be clearly stated. Failure to comply with the provisions of the Act can result in civil or criminal consequences, although the specific penalties are not detailed within the text provided. The National Health Act 1953 and related regulations may outline penalties for non-compliance with the Act's provisions, which could include fines, imprisonment, or other penalties as deemed appropriate by the courts. The exact nature and severity of the penalties would depend on the specific circumstances of the breach and the relevant provisions of the Act and any subordinate legislation.