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

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the supply of therapeutic goods to ensure their quality, safety, and efficacy. The Act addresses the need for a comprehensive legal framework governing the importation, manufacture, and distribution of therapeutic goods, including medicines, medical devices, and blood products. The Therapeutic Goods Administration (TGA) is the executive arm of the Commonwealth Government responsible for administering the Act. In this context, on 27 May 2015, the delegate of the Secretary of the Department of Health granted consent under the Act to Baxter Healthcare Pty Ltd for the supply of specific products that did not conform with certain labelling requirements. This consent aimed to facilitate a smooth transition of sponsorship from Baxter Healthcare to Baxalta, ensuring continuity of supply and minimal disruption. The consent was subject to conditions designed to maintain the quality, safety, and efficacy of the products, including the timely transfer of sponsorship and the use of Baxter-labelled stock until the end of the labelling grace period.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a broad range of products including medicines, medical devices, blood, tissues, and cosmetics. The Act applies to entities such as manufacturers, importers, sponsors, and suppliers of these goods, ensuring they meet safety, quality, and efficacy standards. The jurisdictional reach of the Act is national, with the Therapeutic Goods Administration (TGA) administering its provisions. The Act provides for various exclusions and exemptions, such as for personal use of therapeutic goods or for goods supplied under certain conditions like clinical trials. The scope of the Act can be extended or restricted through subordinate instruments, such as Therapeutic Goods Orders, which detail specific requirements for different categories of therapeutic goods. This legislative framework ensures that therapeutic goods available in the Australian market are safe, of high quality, and provide the intended benefits to consumers.

Key Provisions

Under section 14 of the Therapeutic Goods Act 1989, the Secretary of the Department of Health may give consent for certain therapeutic goods to be supplied even if they do not comply with the standards specified in the Therapeutic Goods Order. This consent was given by the delegate of the Secretary, on the application of Baxter Healthcare Pty Ltd, to allow the supply of specific batches of octocog alfa (rch) (ADVATE) products that do not conform to the labelling requirements specified in Therapeutic Goods Order No. 69. The consent permits Baxter’s details to remain on the labels for a 24-month grace period starting from 1 July 2015. The obligations imposed on the parties by this Act include ensuring that the change of sponsorship is formally documented and submitted to the Therapeutic Goods Administration before the global day 1 for separation, which is 1 July 2015. Additionally, it requires that the transfer of sponsorship is marked by the date when the legal agreement between the relinquishing sponsor (Baxter) and the accepting sponsor (Baxalta) takes effect. It is also mandatory to ensure that Baxter labelled stock will be used for two years until 30 June 2017, with minimal or no disruption to ensure continuity of supply. Baxalta must have its labelled stock in the country six months before the end of the labelling grace period, as indicated in the submission dated 24 April 2015. Moreover, processes and measures need to be implemented to ensure there are no gaps in the communication of medical information to patients and safety reporting during the labelling grace period. Failure to comply with the conditions set out in the consent may result in legal consequences. Under the Act, non-compliance with the consent conditions could lead to administrative penalties or legal action. While specific penalties are not detailed in the consent, breaches of the Therapeutic Goods Act 1989 can attract civil or criminal penalties, including fines and imprisonment, depending on the severity of the breach. The Therapeutic Goods Administration has the authority to take enforcement action against entities that do not comply with the terms of the consent, which could include revocation of the consent, fines, or other legal remedies.