Supply of HUMIRA adalimumab (rch) by Abbvie Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the supply, import, and export of therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. One of the significant issues the Act sought to address is the quality control and regulation of therapeutic goods to protect public health. In 2012, the delegate of the Secretary of the Department of Health and Ageing exercised powers under the Act to provide specific consent for the supply of certain therapeutic products that did not fully comply with regulatory standards. This action was taken under the policy objective of maintaining public safety while facilitating the availability of necessary therapeutic goods. The consent granted allowed for the continued supply of HUMIRA adalimumab products by Abbvie Pty Ltd, subject to certain conditions, until August 2014, ensuring that the products met required standards despite a minor labelling discrepancy.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of therapeutic goods including medicines, medical devices, and blood and blood components, ensuring their quality, safety, and efficacy. This Act governs the regulation of these goods throughout Australia, imposing obligations on manufacturers, importers, sponsors, and suppliers to ensure that the goods comply with the standards set forth by the Therapeutic Goods Administration (TGA). The Act applies to entities and individuals involved in the supply of therapeutic goods within Australia, including companies such as Abbvie Pty Ltd, which is authorised to supply specific products under certain conditions. The consent granted by the delegate of the Secretary of the Department of Health and Ageing pertains to the supply of HUMIRA adalimumab products, which do not meet the labelling requirements specified in TGO 69. This consent is limited in scope, being applicable only until August 2014, and is subject to the condition that the labels used must be those currently registered for the product. The Act's provisions can be extended or modified through subordinate instruments, such as the Therapeutic Goods Orders, which provide detailed specifications and standards for various therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") provides a framework for regulating therapeutic goods in Australia, and it includes specific provisions for allowing the supply of goods that do not conform to certain standards or regulations. Section 14 of the Act allows the Secretary of the Department of Health and Ageing to consent to the supply of therapeutic goods that do not comply with specific legislative requirements, while Section 14A outlines the conditions under which such consent may be granted. In this instance, Section 14 consent was given for the supply of HUMIRA adalimumab products by Abbvie Pty Ltd, which do not conform to the label requirements stipulated in clause 3(2)(l) of Therapeutic Goods Order (TGO) 69. This consent allows for the supply of these products until August 2014, provided that the labels used are those currently registered for the product. The obligations imposed on the parties involved by the Act include ensuring compliance with the conditions specified in the consent. The company supplying the products, Abbvie Pty Ltd, must adhere to the use of registered labels for the duration of the consent. Additionally, the Secretary of the Department of Health and Ageing, through the delegate, must monitor the supply of these products to ensure that the conditions of consent are met. This includes verifying that the correct labels are being used and that the products are supplied only until the specified date of August 2014. Failure to comply with the conditions of the consent granted under Section 14 of the Act may result in various consequences. The Act does not explicitly state the specific offences or penalties for non-compliance with the consent conditions, but breaches of the Therapeutic Goods Act generally can lead to significant civil or criminal penalties. For instance, supplying non-compliant therapeutic goods can result in substantial fines and potential imprisonment for individuals found guilty of such offences. The exact penalties depend on the nature and severity of the breach but can include fines of up to $1,215,000 for corporations and $243,000 for individuals, as well as imprisonment for up to five years for serious offences. Furthermore, repeated or wilful breaches can attract even harsher penalties, underscoring the importance of strict compliance with the terms of the consent.