Consent given pursuant to sections 14 and 14A to the supply of the therapeutic goods specified by Baxter Healthcare

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was established to regulate therapeutic goods, including medicines, in order to ensure their safety, quality, and efficacy. This Act was introduced to address the need for a comprehensive regulatory framework governing the supply, advertising, and quality control of therapeutic goods within Australia. One of the key provisions of the Act is the ability for the Secretary of the Department of Health to grant consent for the supply of therapeutic goods that do not fully comply with certain regulatory requirements, subject to specific conditions to mitigate any potential risks. In this context, the Department of Health has granted consent for Baxter Healthcare Pty Ltd to supply specific formulations of octocog alfa (rch) ADVATE under certain conditions aimed at ensuring safe and proper use of the product. The policy objective is to facilitate access to necessary therapeutic goods while maintaining high standards of safety and quality.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation and control of therapeutic goods in Australia, ensuring that these goods are safe, of acceptable quality, and properly labelled. This Act applies to persons and entities involved in the manufacture, supply, import, export, advertising, or sponsorship of therapeutic goods, encompassing a broad range of industries including pharmaceuticals, medical devices, and complementary medicines. The Act’s jurisdiction extends across the Commonwealth of Australia, with specific provisions that may also be supplemented by state and territory laws. Notably, the Act provides for exclusions, exemptions, or thresholds for certain therapeutic goods based on their risk profile and intended use. For instance, lower-risk goods may be subject to less stringent regulatory requirements. The application of the Act can be further extended or restricted through subordinate instruments, such as regulations and orders, which provide detailed specifications and guidelines to ensure compliance with the overarching legislative framework.

Key Provisions

Under the Therapeutic Goods Act 1989, sections 14 and 14A, the Department of Health granted Baxter Healthcare Pty Ltd consent to supply specific vials of octocog alfa (rch) ADVATE in a configuration that does not fully comply with the labelling requirements stipulated in the Therapeutic Goods Order No 69. This consent recognises the unique design of the Baxject III reconstitution system and its ready-to-activate configuration, which allows for minimal labelling to facilitate easier inspection of the vial contents by users. The consent is effective from 15 June 2015 and remains in place until any changes to the Baxject III system could impact the labelling. The Therapeutic Goods Act 1989 imposes certain obligations on the parties involved. Baxter Healthcare Pty Ltd, as the sponsor, must ensure that proper training tools and resources are available to minimise the risk of misuse of the Baxject III reconstitution apparatus. This includes providing detailed reconstitution device guideline booklets, troubleshooting guides, videos, dummy devices, and a welcome kit for health care professionals and patients. Moreover, Baxter must guarantee that its product specialists and medical team are trained to provide formal training on the use of the Baxject III system and can address any ad hoc questions that may arise. Additionally, the approved Product Information and Consumer Medical Information must be included in the Advate packaging. Failure to comply with the conditions set by the Department of Health may result in legal consequences. Under the Therapeutic Goods Act 1989, any breach of the conditions can lead to criminal and civil penalties. Although the specific penalties are not detailed in the notice, breaches of the Act can generally result in fines and imprisonment for individuals, and fines for bodies corporate. The severity of the penalties would depend on the nature and extent of the breach. It is crucial for Baxter Healthcare Pty Ltd to adhere strictly to the conditions to avoid any legal repercussions.