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, is a comprehensive statute designed to regulate therapeutic goods in Australia, ensuring their quality, safety, and efficacy. The Act was introduced to address the need for a unified legal framework governing the regulation of therapeutic goods, which include medicines, medical devices, and blood products. This legislative effort aimed to streamline the regulatory processes and maintain high standards for the supply and distribution of therapeutic goods within the country. Under the authority of the Act, the Therapeutic Goods Administration, a department within the Commonwealth of Australia's Department of Health, was established to administer and enforce the provisions of the Act. The policy objective behind the Act is to protect public health by ensuring that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy, thereby reducing the risks associated with the use of these goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, including medicines, medical devices, blood and blood components, and therapeutic goods related to clinical trials. The Act provides for the control of the quality, efficacy, and safety of these goods through a system of registration and other regulatory measures. The Act applies to entities and individuals involved in the supply, manufacture, or distribution of therapeutic goods within Australia. This includes companies, manufacturers, importers, and suppliers of therapeutic goods. The Act has a national reach, as it is a Commonwealth Act, and applies across the entire country, including all states and territories. However, certain aspects of the Act may be subject to subordinate legislation or regulations that may vary by state or territory. The Act does not apply to goods that are exempt under the Therapeutic Goods (Exempt Therapeutic Goods) Determination 2013, which includes items such as cosmetics, most vitamins and mineral supplements, and certain medical devices. Additionally, some therapeutic goods may be subject to additional regulations or controls under other legislation, such as the Medicines and Related Substances Control Act. The Act may also be extended or restricted through subordinate instruments, such as regulations or orders, which may provide further detail on the application of the Act in specific circumstances.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 concern the consent for the supply of therapeutic goods. In this instance, the Act allows for the supply of two products, protein C (CEPROTIN) 1000IU and 500IU, which do not conform to certain labelling requirements under Therapeutic Goods Order No 69. The consent issued on 27 May 2015 permits the supply of these products with Baxter Healthcare's sponsor details and livery on the labels for a grace period of 24 months, ending on 30 June 2017. During this period, Baxalta will become the sponsor of these products, but Baxter's details will remain on the labels to ensure continuity. The obligations imposed by the Act on the parties involved include the submission of change of sponsorship forms to the Therapeutic Goods Administration before the global day 1 for separation, which is 1 July 2015. The transfer of sponsorship is deemed to occur on the date the legal agreement between the relinquishing sponsor, Baxter, and the accepting sponsor, Baxalta, takes effect. Additionally, Baxter is required to ensure that its labelled stock is used until 30 June 2017, and Baxalta must have its labelled stock in the country six months before the end of the labelling grace period. The Act also mandates that processes and measures be in place to ensure there are no gaps in communication of medical information to patients and safety reporting throughout the grace period. Furthermore, arrangements must be made to promptly refer any queries or complaints concerning the products to Baxalta Australia Pty Ltd. Failure to comply with the conditions stipulated in the Act can lead to various legal consequences. While the Therapeutic Goods Act 1989 does not explicitly state the offences, penalties, or civil/criminal consequences for breaches of these specific provisions, general provisions within the Act provide for penalties for breaches. For example, section 41BA of the Act stipulates that an individual who commits an offence against a provision of the Act is liable to a fine of up to 5,000 penalty units for a corporation and 1,000 penalty units for an individual. In addition to fines, more severe breaches could potentially lead to civil or criminal proceedings under other sections of the Act, which may include imprisonment. The precise penalties and consequences would depend on the nature and severity of the breach.