National Health Act 1953 - Declaration under subsection 85(2AA) (No. PB 12 of 1991)

Overview

The National Health Act 1953 was enacted to provide for the promotion of health and medical services in Australia, among other objectives. One of the significant gaps it aimed to address was the regulation and control of drugs and medicinal preparations to ensure they are safe, effective, and accessible to the public. This legislative instrument, specifically the declaration under subsection 85(2AA), was introduced to refine and update the list of pharmaceutical benefits covered under the Act. The enactment of this instrument was carried out by the Commonwealth of Australia, reflecting the national policy objective to continually assess and adapt the pharmaceutical landscape in line with public health needs. The policy objective here is to ensure that the Pharmaceutical Benefits Scheme remains responsive to changes in medical practices and technological advancements, thus maintaining the scheme’s efficacy and relevance in providing accessible and affordable healthcare to Australians.

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 Miconazole, Norethisterone Acetate, Phenoxymethylpenicillin Hydrabamine, and Prednisolone Stearoylglycolate. This legislative instrument affects the scope of the National Health Act 1953 by removing the specified pharmaceutical products from the purview of Part VII of the Act, which governs the Pharmaceutical Benefits Scheme. The Declaration is applicable nationally, as it is a Commonwealth legislation, and it impacts entities involved in the supply, distribution, and reimbursement of these pharmaceuticals, particularly pharmaceutical manufacturers and suppliers. The Declaration came into operation on 1 December 1991 and is not limited to specific industries or conduct but rather targets the listed transactions and products. The application of this Act may be extended or restricted through subordinate instruments, which may specify additional details or conditions related to the cessation of these pharmaceutical products from the Pharmaceutical Benefits Scheme.

Key Provisions

The National Health Act 1953 includes a provision under subsection 85(2AA) that allows for the declaration of certain drugs and medicinal preparations which will no longer be subject to Part VII of the Act. This legislative instrument, No. PB 12 of 1991, specifies that the Principal Advisor of the Health Care Access Division, Fiona Margaret Howarth, made this declaration following consultation with the Pharmaceutical Benefits Advisory Committee as required by subsection 85(2AB) of the Act (Section 1 and 2). The declaration effectively removes certain medications from the list of those covered under the Pharmaceutical Benefits Scheme, starting from 1 December 1991. Under this legislation, the obligation falls on the Principal Advisor, in their capacity as a delegate of the Minister for Health, to consult with the appropriate advisory committee and make a declaration when it is deemed necessary to exclude certain drugs and preparations from the Pharmaceutical Benefits Scheme. This ensures that the decision is informed by expert advice and aligns with the broader health policy objectives of the government (Section 1 and 2). The medications specified in the Schedule, including Miconazole, Norethisterone Acetate, Phenoxymethylpenicillin Hydrabamine, and Prednisolone Stearoylglycolate, are thus removed from the list of those for which the Commonwealth provides financial assistance under the Scheme. Failure to comply with the provisions of the National Health Act 1953, including making a declaration under subsection 85(2AA), may lead to various legal consequences. While the specific penalties are not detailed in this particular legislative instrument, breaches of the Act could potentially result in administrative or judicial penalties as prescribed by the broader provisions of the Act. Additionally, entities or individuals affected by the declaration may have grounds to challenge the decision in court, seeking judicial review if they believe the decision was made without proper authority or was otherwise unlawful (Section 2).