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 is a pivotal piece of Australian legislation introduced to regulate the manufacturing, supply, and advertising of therapeutic goods, ensuring their quality, safety, and efficacy. Enacted by the Commonwealth Parliament, the Act aims to address the need for a comprehensive regulatory framework to protect public health. One of the key functions of the Act is to provide mechanisms for the Therapeutic Goods Administration to control and monitor therapeutic goods, including medicines, medical devices, and blood products. The policy objective is to facilitate access to therapeutic goods that are safe, of high quality, and effective, while also providing for appropriate advertising and labelling standards to inform consumers and healthcare professionals. The Act empowers the TGA to issue consents and approvals, as seen in the case of Baxter Healthcare's application, ensuring compliance with regulatory standards during transitions such as changes in sponsorship.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood products, with the Act applying to any person or entity involved in the supply, importation, and advertising of these goods. The Act extends to the entire Commonwealth, ensuring a uniform regulatory approach across all states and territories. In the case of the Therapeutic Goods Order No 69, which pertains to labelling requirements for medicines, the Act allows for certain deviations under specific circumstances, such as a change in sponsorship, provided that appropriate consent is obtained from the Therapeutic Goods Administration. The scope of this legislation is further defined by various exclusions and exemptions, as well as thresholds that determine the need for registration and compliance with certain standards. Additionally, the Act empowers the creation of subordinate instruments to refine and extend its application, ensuring a comprehensive regulatory framework that adapts to evolving industry practices and public health needs.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provides the legal framework for the Therapeutic Goods Administration (TGA) to consent to certain variations in the supply of therapeutic goods. In this instance, section 14(1) allows the Secretary of the Department of Health, through a delegate, to give consent for the supply of goods that do not fully conform to specified regulations, provided that it is in the public interest. Section 14A(1) further empowers the Secretary to impose conditions on such consent to ensure public safety and the integrity of the therapeutic goods market. Here, the delegate has consented to the supply of nonacog gamma (RIXUBIS) in various dosages by Baxalta, which does not conform to the labelling requirements as outlined in Therapeutic Goods Order No 69. This consent is subject to conditions to ensure a smooth transition in sponsorship and labelling. The obligations imposed on the parties involved by this Act are quite specific. Firstly, Baxalta and Baxter must ensure that the change of sponsorship is formally documented and submitted to the TGA before their global day 1 for separation, which is 1 July 2015. This involves the submission of relevant change of sponsorship forms and the execution of a legal agreement between the relinquishing (Baxter) and accepting (Baxalta) sponsors. Secondly, Baxalta must commit to using Baxter-labelled stock for a period of two years, which ends on 30 June 2017, to ensure continuity of supply. Additionally, Baxalta is required to have its labelled stock in the country six months before the end of the labelling grace period, as stipulated in their submission dated 24 April 2015. Finally, Baxalta must implement processes and measures to maintain communication with patients and ensure safety reporting throughout the labelling grace period. Failure to comply with the conditions set forth in the consent may lead to various consequences. Under the Therapeutic Goods Act 1989, breaches of the conditions could result in both civil and criminal penalties. Specifically, section 21(1) of the Act outlines that any person who contravenes an order or condition imposed by the Secretary can be liable to a penalty. For corporations, the maximum penalty under section 21(2) is $2,100,000 for a serious breach and $210,000 for other breaches. Moreover, individuals who are officers of the corporation and are responsible for the contravention may face personal penalties under section 21(3), which can include fines and imprisonment. These stringent penalties underscore the importance of adhering to the conditions imposed by the TGA to maintain the safety and efficacy of therapeutic goods.