Supply of Agrippal inactivated influenza vaccine by Novartis Vaccines and Diagnostics Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring they meet quality, safety, and efficacy standards. The 2013 consent granted by the delegate of the Secretary of the Department of Health under sections 14 and 14A of the Act exemplifies the Act's flexibility to accommodate specific circumstances while maintaining regulatory oversight. This particular consent allowed Novartis Vaccines and Diagnostics Pty Ltd to supply AGRIPPAL inactivated influenza vaccine, which did not fully comply with certain labelling requirements due to physical constraints of the syringe label. The consent recognises the practical limitations faced by manufacturers while reinforcing the Act’s commitment to safeguarding public health through appropriate therapeutic goods regulation.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, and in this instance, consent has been granted under sections 14 and 14A of the Act to allow for a specific exemption concerning the labelling of a therapeutic product. The legislation applies to entities involved in the supply of therapeutic goods, such as pharmaceutical companies like Novartis Vaccines and Diagnostics Pty Ltd, which in this case is based in North Ryde, NSW. The Act’s jurisdiction covers the entire Commonwealth of Australia, ensuring a uniform standard across all states and territories. The consent provided allows the named company to supply the AGRIPPAL inactivated influenza vaccine with certain deviations from the Therapeutic Goods Order No 69, specifically regarding the minimum letter height of the sponsor's name and the listing of all active ingredients on the syringe label, due to the spatial limitations of the label. The consent does not extend to other types of therapeutic goods or different circumstances, thereby maintaining the integrity of the Act's primary labelling requirements for medicines.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) is a key piece of legislation governing the regulation of therapeutic goods in Australia, and the 2013 Gazette consent provided by the Department of Health’s delegate for the supply of AGRIPPAL inactivated influenza vaccine (section 14) and the non-conformity with certain labelling requirements (section 14A) offers an example of how the Act can be applied in practice. Specifically, the Act allows the delegate to consent to the supply of therapeutic goods (section 14) and to variations from certain standards or requirements to ensure the safe and effective use of these goods (section 14A). In this instance, Novartis Vaccines and Diagnostics Pty Ltd has been granted consent to supply AGRIPPAL inactivated influenza vaccine, which does not conform to certain labelling requirements in Therapeutic Goods Order No 69 (subsection 14A(2)). The obligations and requirements imposed by the Act on entities such as Novartis Vaccines and Diagnostics Pty Ltd include adherence to the standards and requirements set out in the Therapeutic Goods Orders, unless consent has been granted by the delegate. This includes the requirement to label therapeutic goods in a specific manner, as outlined in Therapeutic Goods Order No 69. However, in this case, the delegate has granted consent for the vaccine not to conform to certain labelling requirements due to space constraints on the syringe label. This highlights the Act’s flexibility in ensuring the safe and effective use of therapeutic goods, while also recognising practical limitations in labelling. The Therapeutic Goods Act 1989 imposes penalties and consequences for breaches of its provisions. For example, section 26 of the Act provides that a person who contravenes a provision of the Act, or an order or direction made under it, is guilty of an offence and liable to a fine. The maximum penalties for offences under the Act vary depending on the nature and severity of the offence, with some offences carrying maximum penalties of up to $2.1 million for corporations and $210,000 for individuals (subsection 31(2)). Additionally, section 30 of the Act provides for civil penalties for breaches of certain provisions, including pecuniary penalties of up to $2.6 million for corporations and $520,000 for individuals (subsection 30(3)). These penalties serve as a deterrent to non-compliance with the Act and its associated orders and directions. In summary, the Therapeutic Goods Act 1989 provides a framework for the regulation of therapeutic goods in Australia, with key provisions including the ability of the delegate to consent to the supply of therapeutic goods (section 14) and to variations from certain standards or requirements (section 14A). Obligations and requirements imposed by the Act on entities such as Novartis Vaccines and Diagnostics Pty Ltd include adherence to the standards and requirements set out in the Therapeutic Goods Orders, unless consent has been granted by the delegate. Breaches of the Act and its associated orders and directions can result in criminal and civil penalties, with maximum penalties varying depending on the nature and severity of the offence. The 2013 Gazette consent for the supply of AGRIPPAL inactivated influenza vaccine and non-conformity with certain labelling requirements demonstrates the Act’s flexibility in ensuring the safe and effective use of therapeutic goods, while also recognising practical limitations in labelling.