National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 15 of 2000)

Overview

The National Health Act 1953, enacted by the Parliament of Australia, was designed to establish and maintain the national health standards and services across the country, including the provision of pharmaceutical benefits. One of the specific objectives of this Act is to ensure that Australians have access to affordable and necessary medications by including them on the Pharmaceutical Benefits Scheme (PBS). The legislation was introduced to address the gap in access to essential medicines for Australians, ensuring that such medications are available and affordable to the public. The Pharmaceutical Benefits Declaration under subsection 85(2AA) of the Act, made by the Assistant Secretary of the Pharmaceutical Benefits Branch, Department of Health and Aged Care, on behalf of the Minister for Health and Aged Care, serves to adjust the list of medications covered by the PBS. This particular declaration, which came into effect on 1 November 2000, specifies that certain drugs and medicinal preparations, such as Chlorothiazid, Codeine Phosphate with Aspirin, Dienoestrol, and Fluoxymesterone, would no longer be subject to the provisions of Part VII of the Act. This adjustment was made following the advice of the Pharmaceutical Benefits Advisory Committee, aligning with the policy objective of refining the PBS to focus on medications that offer the greatest benefit to the public health.

Scope and Application

The Pharmaceutical Benefits Declaration under subsection 85(2AA) of the National Health Act 1953 applies to specific drugs and medicinal preparations listed in the Schedule, thereby removing them from the coverage provided under Part VII of the National Health Act 1953. This Act is administered by the Commonwealth of Australia and operates on a national level, impacting all persons and entities within Australia that may be affected by the removal of these pharmaceutical products from the Pharmaceutical Benefits Scheme (PBS). The Declaration specifically targets particular drugs, including Chlorothiazid, Codeine Phosphate with Aspirin, Dienoestrol, and Fluoxymesterone, which are detailed in the Schedule. The exclusion of these drugs from the PBS affects the availability of subsidised medication and consequently impacts patients, healthcare providers, and possibly pharmaceutical companies involved with these products. The Declaration does not explicitly state any exclusions or exemptions beyond the listed drugs and medicinal preparations, and its effect is direct and immediate upon coming into operation on 1 November 2000.

Key Provisions

The main operative sections of this legislative instrument are sections 2 and the Schedule. Section 2 of the Declaration specifies that the drugs and medicinal preparations listed in the Schedule will cease to be subject to Part VII of the National Health Act 1953, which pertains to the Pharmaceutical Benefits Scheme (PBS). The Schedule lists the specific drugs and medicinal preparations affected by this change: Chlorothiazid, Codeine Phosphate with Aspirin, Dienoestrol, and Fluoxymesterone. This declaration effectively removes these substances from the PBS, meaning they will no longer be subsidised by the government for prescription under the scheme. The Act imposes specific obligations and requirements on parties and entities governed by it. For instance, the Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Aged Care, and Delegate of the Minister for Health and Aged Care, in this case, Brett Anthony Lennon, must obtain advice from the Pharmaceutical Benefits Advisory Committee before making such a declaration. This requirement ensures that decisions to alter the PBS are informed by expert advice and consider the implications of such changes. Additionally, the declaration must specify the date of operation, which in this case is 1 November 2000. This provides clear and definitive timing for when the changes take effect, ensuring all relevant parties are aware of the new regulations. There are no explicit offences, penalties, or consequences for breach outlined in this specific legislative instrument. However, non-compliance with the National Health Act 1953 generally could lead to legal repercussions. For example, unauthorised actions that deviate from the Act's provisions could result in civil or criminal penalties. The Act itself provides for penalties in various sections, with the maximum penalties varying depending on the offence. For instance, knowingly providing false or misleading information to obtain a benefit under the Act could result in fines or imprisonment. However, the specific penalties would be determined by the courts based on the nature and severity of the offence, as well as any relevant case law.