Consent given pursuant to sections 14 and 14A to the importation and supply of the therapeutic goods specified by GlaxoSmithKline Australia

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to provide a comprehensive regulatory framework for the regulation of therapeutic goods in Australia, aiming to ensure that such goods are safe, of high quality, and perform as claimed. The Act was introduced to address the need for a unified regulatory system that would streamline the approval, registration, and monitoring of therapeutic goods, thereby protecting public health. Enacted by the Commonwealth Parliament, the policy objective of the Act is to safeguard the health and safety of the Australian public by ensuring that therapeutic goods available in Australia meet necessary standards of quality, safety, and efficacy. This legislation enables the Therapeutic Goods Administration (TGA) to carry out its regulatory functions, including the granting of consents for the importation and supply of therapeutic goods under certain conditions, as exemplified by the case of the rabies virus vaccine (Inactivated) (RABIPUR). This consent process allows for flexibility in the regulatory requirements to accommodate specific circumstances while maintaining the overarching goal of protecting public health.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medicines, medical devices, and blood and blood components. The Act applies to entities such as sponsors, manufacturers, importers, and suppliers of therapeutic goods within the Commonwealth of Australia. The Act's jurisdiction covers the entire nation, ensuring a unified approach to the regulation of therapeutic goods across states and territories. The Act includes various provisions for exemptions and exclusions, often specified through Therapeutic Goods Orders, which provide detailed requirements and standards for different types of therapeutic goods. In certain circumstances, the Therapeutic Goods Administration may grant consents under sections such as 14 and 14A to allow for deviations from specified requirements, subject to certain conditions. These consents may be issued to allow the importation or supply of goods that do not fully comply with particular standards, provided that public health and safety are adequately safeguarded. Subordinate instruments such as Therapeutic Goods Orders extend and detail the application of the Act, thereby providing comprehensive regulatory coverage for therapeutic goods in Australia.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989, a delegate of the Secretary of the Department of Health granted consent to GlaxoSmithKline Australia Pty Ltd for the importation and supply of a specific rabies virus vaccine. This consent allows for the vaccine, RABIPUR, to be supplied with labels that do not conform to the usual requirements as stipulated in the Therapeutic Goods Order Number 69. Specifically, the labels will bear the name and address of the previous sponsor, CSL Biotherapies, instead of the current sponsor, GlaxoSmithKline Australia Pty Ltd. This consent was issued on 24 December 2015 and is effective until 30 November 2016. It is contingent on the use of previously approved labels for CSL Biotherapies and the establishment of arrangements to ensure that any queries or complaints about the product are promptly referred to GlaxoSmithKline Australia Pty Ltd. The obligations imposed by this consent on GlaxoSmithKline Australia Pty Ltd include ensuring that the labels used are those previously approved for CSL Biotherapies. Additionally, GlaxoSmithKline Australia Pty Ltd must maintain effective communication channels with CSL Biotherapies to facilitate the prompt referral of any consumer queries or complaints related to the vaccine. This requirement underscores the importance of clear and efficient communication in the management of therapeutic goods, particularly when there is a change in sponsorship. Failure to comply with the conditions set forth in the consent may result in legal consequences. Although the Therapeutic Goods Act 1989 does not specify penalties for breaches of consents issued under sections 14 and 14A, general provisions within the Act provide for significant penalties for non-compliance with therapeutic goods regulations. For example, breaches of certain provisions of the Act can result in substantial fines and, in severe cases, criminal charges. The specific penalties for such breaches are determined by the nature and severity of the offence, with potential outcomes including fines of up to $1.1 million for corporations and imprisonment for up to five years for individuals, as stipulated in the relevant sections of the Act. Compliance with these conditions is therefore critical to avoid such repercussions.