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 Australian Parliament, was introduced to regulate the quality, safety, and efficacy of therapeutic goods available in Australia. This Act serves to protect the public from harm and to ensure that therapeutic goods are safe, of high quality, and effective for their intended use. On 27 May 2015, the delegate of the Secretary of the Department of Health, under the authority of the Act, granted a consent for Baxter Healthcare to supply specific vials of octocog alfa (rch) (RECOMBINATE) that did not conform to the labelling requirements of the Therapeutic Goods Order No 69. This consent allowed for a two-year grace period, during which Baxter’s sponsor details would appear on the labels, while Baxalta Australia Pty Ltd became the new sponsor. The consent was made subject to specific conditions to ensure a smooth transition and continuity of supply without any disruption to the communication of medical information to patients and safety reporting.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, including medicines, medical devices, and blood products, throughout the Commonwealth of Australia. The Act primarily governs the import, supply, and advertising of these goods to ensure they meet safety, quality, and efficacy standards. It applies to various stakeholders, including manufacturers, sponsors, importers, and suppliers of therapeutic goods. The legislation extends its reach to cover all therapeutic goods distributed or supplied within Australia, encompassing both domestic and imported products. Under the Act, certain exclusions and exemptions exist, such as for goods used for personal or non-commercial purposes. The Therapeutic Goods Administration (TGA), acting on behalf of the Department of Health, administers and enforces the Act, and it may delegate certain functions to other authorities. Additionally, the scope of the Act can be extended or restricted through subordinate instruments, such as therapeutic goods orders and regulations, which provide detailed requirements and standards for specific therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provide the legal basis for the consent given to Baxter Healthcare on 27 May 2015. This consent permits the supply of certain pharmaceutical products that do not conform to the labelling requirements set out in Therapeutic Goods Order No 69. The products in question are octocog alfa (rch) (RECOMBINATE) in various dosages, namely 250IU, 500IU, and 1000IU powder for injection vials, which include a diluent vial. The consent allows Baxter Healthcare to continue using its sponsor details and livery on the product labels for a labelling grace period of 24 months, from 1 July 2015 to 30 June 2017, while the new sponsor, Baxalta Australia Pty Ltd, takes over the responsibility. The obligations imposed by the Act on Baxter Healthcare and Baxalta Australia Pty Ltd include the timely submission of change of sponsorship forms to the Therapeutic Goods Administration prior to the global day 1 for separation, which was set as 1 July 2015. It is also required that the legal agreement between the relinquishing and accepting sponsors is finalised before the transfer of sponsorship takes effect. Furthermore, Baxter Healthcare must ensure that any labelled stock it produces is used within the specified two-year period ending on 30 June 2017. Baxalta Australia Pty Ltd must ensure that its labelled stock is available in the country six months before the end of the labelling grace period, as stipulated in a submission dated 24 April 2015. Both sponsors must implement processes and measures to maintain effective communication with patients and ensure safety reporting throughout the transition period. Additionally, Baxter Healthcare must have arrangements in place for prompt referral of any queries or complaints about the products to Baxalta Australia Pty Ltd. Failure to comply with the conditions set out in the consent may result in various civil and criminal consequences under the Therapeutic Goods Act 1989. Although specific penalties are not detailed in the notice, breaches of the Act could lead to enforcement actions by the Therapeutic Goods Administration, including fines, product recalls, and legal proceedings. The Act also empowers the Administration to issue infringement notices for minor breaches, which carry a maximum penalty of $2,200 for individuals and $11,000 for corporations. More serious breaches could result in criminal charges, with potential penalties including higher fines and imprisonment, depending on the severity of the offence and the discretion of the court.