Export of CSL Brazil Human Coagulation Factor VIII for Injection 500 IU by CSL Behring (Australia) Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted by the Commonwealth Parliament to regulate the quality, safety, efficacy, and timely availability of therapeutic goods, including medicines, in Australia. It was introduced to address the problem of ensuring that therapeutic goods available in Australia meet acceptable standards for quality, safety, and efficacy, thereby protecting public health. One of the key functions of the Act is to facilitate the export of therapeutic goods under certain conditions that ensure they meet necessary health and safety standards. In a specific instance on 30 May 2013, a delegate of the Secretary of the Department of Health and Ageing granted consent under sections 14 and 14A of the Act for CSL Behring (Australia) Pty Ltd to export CSL Brazil Human Coagulation Factor VIII for Injection 500 IU (AUSTL 162792) with certain conditions. This decision was made to balance the need for therapeutic goods with the requirement to maintain strict quality controls, thereby fulfilling the policy objective of safeguarding public health while supporting the export of Australian-made therapeutic products.

Scope and Application

The Therapeutic Goods Act 1989, specifically section 14 and 14A, applies to the export of therapeutic goods by entities such as CSL Behring (Australia) Pty Ltd. The Act allows for certain exemptions to the standard requirements, such as those stipulated in pharmacopeia monographs, provided certain conditions are met. In this case, the Act permits the export of CSL Brazil Human Coagulation Factor VIII for Injection 500 IU under specific conditions, including deviations from the European Pharmacopeia monograph regarding the amount of von Willebrand factor (vWF). This exemption applies to CSL Behring (Australia) Pty Ltd and is limited to the geographic scope of the Commonwealth of Australia, with additional oversight by the Therapeutic Goods Administration (TGA). The exemption is subject to conditions, such as the submission of notifications for each batch released and adherence to specific vWF specifications, and is in effect until 31 March 2014. The Act’s application may be extended or modified through subordinate instruments, allowing for further regulation and oversight of the therapeutic goods in question.

Key Provisions

The Therapeutic Goods Act 1989, as amended, provides the legal framework for regulating therapeutic goods in Australia, including medicines, medical devices, and blood products. Under sections 14 and 14A of the Act, a delegate of the Secretary of the Department of Health and Ageing may grant consent for the export of therapeutic goods that do not conform to certain standards. In this instance, the delegate has consented to the export of CSL Brazil Human Coagulation Factor VIII for Injection 500 IU by CSL Behring (Australia) Pty Ltd, provided certain conditions are met (section 15(1)). These conditions include the submission of notification to the Therapeutic Goods Administration (TGA) for each batch of the product released under this exemption, maintaining a specific ratio of von Willebrand factor (vWF) to Factor VIII (2.4:1), and adhering to specific vWF specifications for the product. The Act imposes several obligations on the parties involved. CSL Behring (Australia) Pty Ltd must submit notifications to the TGA for each batch of the exported product. This requirement ensures that the TGA is informed of the product's export and can monitor its compliance with the conditions set forth in the consent. Additionally, the company must ensure that the product meets the specified vWF to Factor VIII ratio and vWF specifications for the product. These specifications are crucial for maintaining the product's quality and efficacy, particularly in the context of coagulation factor treatments. Failure to comply with the conditions of the consent granted under sections 14 and 14A of the Act may result in various consequences. Firstly, the product may not be exported under the terms of the consent, which could have significant implications for the company's operations and the availability of the product in the target market. Secondly, non-compliance may lead to the revocation of the consent, which would further restrict the export of the product. In more severe cases, breaches of the Act may result in criminal or civil penalties, including fines and imprisonment. The specific penalties depend on the nature and severity of the breach, but they can be substantial, reflecting the importance of ensuring the safety and quality of therapeutic goods in Australia and abroad.