Supply of CSL Panama Human Coagulation Factor VIII for Injection 250 IU by CSL Behring (Australia) Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia, addresses the regulation of therapeutic goods to ensure public health and safety. This legislation was introduced to fill the gap in the oversight and quality control of therapeutic goods, ensuring they meet safety, quality, and efficacy standards before being made available to the public. The Act provides the framework for the regulation of therapeutic goods, including medicines, medical devices, blood, and tissues. In this context, the Therapeutic Goods Administration (TGA), as part of the Department of Health, acts as the key regulatory body. The policy objective of the Act is to protect and enhance public health by ensuring that therapeutic goods available in Australia are of an acceptable standard and that their benefits outweigh any risks. The Act allows for the granting of specific consents, such as the one provided by the delegate of the Secretary of the Department of Health and Ageing on 6 May 2013, to facilitate the export of therapeutic goods under certain conditions, ensuring that the products meet necessary safety and efficacy standards despite minor deviations from pharmacopeia requirements.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation and control of therapeutic goods in Australia, encompassing entities such as manufacturers, importers, and suppliers of these goods, as well as governing the conduct and transactions related to their distribution and sale. Specifically, this Act extends to the Commonwealth level and provides a national framework for ensuring the safety, quality, and efficacy of therapeutic goods. Section 14 and 14A of the Act allow for certain exemptions and variations from standard regulatory requirements, subject to the approval of a delegate of the Secretary of the Department of Health and Ageing. In the case of CSL Behring (Australia) Pty Ltd, the Act permits the export of CSL Panama Human Coagulation Factor VIII for Injection 250 IU, provided it does not meet the specific European Pharmacopeia monograph requirements concerning the von Willebrand factor content. This exemption is subject to conditions such as notifying the Therapeutic Goods Administration for each batch and maintaining a specific vWF to Factor VIII ratio. The consent given under this section is in effect until 31 March 2014, demonstrating the Act's flexibility in addressing specific industry needs while maintaining overarching regulatory standards.

Key Provisions

The Therapeutic Goods Act 1989, sections 14 and 14A, allows the Secretary of the Department of Health and Ageing to consent to certain activities that might otherwise be prohibited under the Act. In this instance, the delegate of the Secretary has granted permission for CSL Behring (Australia) Pty Ltd to export CSL Panama Human Coagulation Factor VIII for Injection 250 IU (AUSTL 132713), with a specific exemption from the European Pharmacopeia's monograph requirement that the amount of von Willebrand factor (vWF) should not exceed 140% of the potency stated on the label (section 14(a)). This consent is given with particular conditions that must be adhered to, as outlined in section 15(1) of the Act. The obligations imposed by this consent on CSL Behring (Australia) Pty Ltd include submitting notification to the Therapeutic Goods Administration (TGA) for each batch of the product that is released under this exemption. Additionally, the ratio of vWF to Factor VIII in the product released under this exemption must nominally be 2.4:1, with specific vWF specifications of 600 IU (with a range of 360 to 840 IU) for each vial containing 250 IU of human coagulation factor VIII. These specifications must be strictly followed to ensure compliance with the terms of the consent. Failure to comply with the conditions of this consent may result in legal repercussions. While the Therapeutic Goods Act does not explicitly outline penalties for breaches in this specific context, non-compliance with the Act generally can lead to both civil and criminal consequences. Civil penalties can include fines, whereas criminal penalties can involve imprisonment, depending on the severity of the breach. The maximum penalties for offences under the Therapeutic Goods Act can vary, but they can be substantial, reflecting the importance of the legislation in regulating therapeutic goods in Australia.