National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 10 of 1995)

Overview

The National Health Act 1953 was enacted by the Parliament of Australia to establish a framework for the administration of national health services, including the Pharmaceutical Benefits Scheme (PBS). The Act was introduced to address the need for a structured system to provide access to affordable medications for all Australians. The 1995 legislative instrument, F2007B01084, is a declaration made under the authority of the National Health Act 1953, aiming to update the list of drugs and medicinal preparations covered by the PBS. The policy objective behind this legislative instrument is to ensure that the PBS remains current and effective by removing outdated or less necessary pharmaceutical items, thereby optimising the allocation of resources towards treatments that offer the greatest benefit to the community. This declaration, effective from 1 August 1995, removes certain specified drugs and medicinal preparations from the scope of Part VII of the National Health Act 1953, reflecting an ongoing effort to refine the scheme’s coverage based on contemporary medical needs and advice from the Pharmaceutical Benefits Advisory Committee.

Scope and Application

The National Health Act 1953, as amended, provides the legislative framework for the Pharmaceutical Benefits Scheme (PBS) in Australia, which subsidises the cost of certain medicines to make them more affordable and accessible to the public. The Pharmaceutical Benefits Declaration under subsection 85 (2AA) of this Act specifies particular drugs and medicinal preparations that are no longer subject to the provisions of Part VII of the Act, effectively removing them from the PBS. This particular declaration, issued by David Trevor Graham as the Assistant Secretary, Pharmaceutical Benefits Branch, Department of Human Services and Health, and Delegate of the Minister for Human Services and Health, applies to the drugs listed in the Schedule, such as Adrenaline Hydrochloride, Antazoline Phosphate with Naphazoline Hydrochloride, and others. The cessation of these drugs from the PBS means they are no longer subsidised under the scheme as of the operation date of 1 August 1995. The Act's reach is national, affecting all entities and individuals within Australia who rely on the PBS for medicine costs. There are no exclusions or exemptions mentioned in this specific declaration, and its application is direct without the need for subordinate instruments to extend or restrict its effect.

Key Provisions

The Declaration under subsection 85(2AA) of the National Health Act 1953 (section 85) specifies that certain drugs and medicinal preparations will cease to be subject to Part VII of the Act. This means that these particular items will no longer be covered under the Pharmaceutical Benefits Scheme (PBS), effective from 1 August 1995. The listed drugs and preparations, which include Adrenaline Hydrochloride, Antazoline Phosphate with Naphazoline Hydrochloride, and several others, are detailed in the Schedule attached to the Declaration. This legislative instrument was made by David Trevor Graham, the Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Human Services and Health, and Delegate of the Minister for Human Services and Health, after consulting the Pharmaceutical Benefits Advisory Committee as required by subsection 85(2AB). The obligations imposed by this Act primarily concern the removal of specified drugs and preparations from the list of items covered under the PBS. This means that from the effective date of the Declaration, these items will no longer be subsidised under the scheme, which affects both healthcare providers and patients. Providers will no longer be able to claim a rebate from the government for these medications, and patients may face higher out-of-pocket costs for these treatments. Additionally, pharmaceutical companies that manufacture or supply these drugs will no longer be eligible for reimbursement from the government for supplies of these items to patients under the PBS. Breaching the provisions of the National Health Act 1953 can lead to various civil and criminal consequences. Although the specific penalties for breaches are not detailed in this Declaration, general provisions of the Act may apply. For instance, contravening the provisions of the Act can result in fines or imprisonment, depending on the severity of the breach. Specifically, under section 12 of the Act, a person who contravenes a provision of the Act may be liable to a penalty of up to $22,200 for an individual offence and $111,000 for a corporate offence. Additionally, in cases of serious or repeated breaches, the Act may also provide for other civil remedies, such as injunctions or compensation orders. These penalties underscore the importance of compliance with the provisions of the Act to avoid legal repercussions.