Consent given pursuant to Sections 14 and 14A for the importation and supply of the therapeutic goods specified by Sanofi-Aventis Australia

Overview

The Therapeutic Goods Act 1989 is a pivotal piece of Australian legislation aimed at regulating the importation, supply, and advertising of therapeutic goods, including medicines, medical devices, and blood products. Enacted by the Australian Parliament, the Act seeks to ensure that therapeutic goods available in the market meet appropriate standards of quality, safety, and efficacy. This legislative framework was introduced to address the need for a comprehensive regulatory system that safeguards public health by controlling the therapeutic goods industry. In specific instances, such as the one highlighted on 15 April 2015, the Act allows the delegate of the Secretary of the Department of Health to provide consent for the importation and supply of goods that do not fully conform to specified standards, subject to certain conditions that ensure the products' safety and efficacy. This flexibility is part of the policy objective to balance regulatory rigour with the practicalities of the therapeutic goods market.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods within Australia, encompassing a broad range of products including medicines, medical devices, blood, and tissues. The Act applies to entities and individuals involved in the importation, manufacture, supply, and advertising of therapeutic goods, ensuring they meet specified standards to protect public health. The Act's jurisdictional reach is nationwide, applying to the Commonwealth, states, and territories of Australia. However, certain exclusions exist, such as therapeutic goods that are exempt under specific provisions of the Act or subject to regulation under other legislation, like the Customs Act 1901. Additionally, the Therapeutic Goods Administration can extend or restrict the application of the Act through subordinate instruments, such as regulations and orders, which provide detailed specifications and standards for various therapeutic goods. These instruments help ensure compliance and safety within the therapeutic goods market.

Key Provisions

The Therapeutic Goods Act 1989, in particular sections 14 and 14A, governs the approval for the importation and supply of therapeutic goods that do not fully comply with the established standards. In this case, section 14 allows for the delegate of the Secretary to grant consent for the supply of therapeutic goods that do not conform to certain requirements, while section 14A imposes conditions on such consent to ensure the safety, quality, and efficacy of the therapeutic goods. On 15 April 2015, the delegate granted consent to Sanofi-Aventis Australia Pty Ltd for the importation and supply of three specific sevelamer carbonate products, which did not meet the assay limits as stipulated in Therapeutic Goods Order No. 78. The obligations imposed by the Act on the parties involved are significant. Sanofi-Aventis Australia Pty Ltd must ensure that the products they supply meet the conditions set by the delegate, which include conforming to an agreed assay titratable amines limit and applying specific limits for the content of sevelamer carbonate. The products must also meet the agreed assay titratable amines test and maintain a content range of 90-110% of the labelled claim. These conditions are intended to safeguard public health by ensuring that the therapeutic goods supplied are of an acceptable standard despite not fully complying with the standard for tablets and capsules. Failure to comply with the conditions set out in the consent or the Act can result in serious consequences. Under the Therapeutic Goods Act 1989, breaches can lead to both civil and criminal penalties. Civil penalties may include fines, while criminal penalties can include imprisonment, reflecting the seriousness with which the Act treats non-compliance. The exact penalties depend on the nature and severity of the breach but can be significant, underscoring the importance of adhering to the conditions and obligations set out in the legislation.