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 was enacted to regulate the quality, safety, efficacy and timely access to therapeutic goods in Australia. It was introduced to address the need for comprehensive oversight of therapeutic goods, including medicines, medical devices, and other health-related products, to protect public health. The Therapeutic Goods Act provides the legal framework for the Therapeutic Goods Administration (TGA) to ensure that therapeutic goods available in Australia meet required standards and are properly advertised and labelled. The Act was enacted by the Parliament of Australia and aims to protect public health by ensuring that therapeutic goods are of acceptable quality, safety, and efficacy. The consent granted by the delegate of the Secretary under sections 14 and 14A of the Therapeutic Goods Act 1989 is an example of the regulatory flexibility provided by the Act to manage specific supply issues while maintaining the overall safety and quality of therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods and their supply within Australia. This Act encompasses the regulation of the development, manufacture, supply, importation, and exportation of therapeutic goods. It applies to entities such as pharmaceutical companies, medical device manufacturers, and healthcare providers, as well as individuals involved in the supply of these goods. The Act extends across the Commonwealth, including all states and territories, thus providing a uniform national regulatory framework for therapeutic goods. The Act includes provisions for exemptions and exclusions, such as certain biological products and medical devices, but these are limited and subject to specific conditions. The scope of the Act can be extended through subordinate legislation, such as regulations and orders, which provide further detail on the requirements for specific types of therapeutic goods. The Therapeutic Goods (Labelling) Order 2016, for instance, provides detailed requirements for the labelling of therapeutic goods, including the consent process described in the notice for Baxter Healthcare's products.

Key Provisions

The Therapeutic Goods Act 1989 (section 14 and 14A) governs the consent for the supply of specific therapeutic goods under conditions set by the delegate of the Secretary of the Department of Health. In this case, the consent was given on 27 May 2015 for Baxter Healthcare, allowing the supply of several variants of the KIOVIG product, which is a normal immunoglobulin (human) solution for injection, with Baxter's details appearing on the labels despite a change in sponsorship to Baxalta. This consent permits a labelling grace period of 24 months starting from 1 July 2015, during which Baxter's details will remain on the product labels. The obligations imposed by the Act on the parties involved include the submission of relevant 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 considered effective from the date the legal agreement between the relinquishing and accepting sponsors takes effect. Additionally, it is required that Baxter-labelled stock is used for two years, concluding on 30 June 2017, with minimal disruption to ensure continuity of supply. Baxalta-labelled stock must be available in the country six months before the end of the labelling grace period, as specified in the submission dated 24 April 2015. Moreover, processes and measures must be implemented to ensure continuous communication of medical information to patients and safety reporting throughout the labelling grace period. The labels for these products must be those previously approved for Baxter Healthcare Pty Ltd, and arrangements are in place for prompt referral of any queries or complaints concerning the products to Baxalta Australia Pty Ltd. Failure to comply with the conditions set out in the consent could lead to various civil or criminal consequences. Under the Therapeutic Goods Act 1989, breaches of the Act can result in offences and penalties. For instance, providing false or misleading information in the application for consent can lead to criminal charges, with potential penalties including fines and imprisonment. Additionally, failure to adhere to the labelling requirements can result in civil penalties, which may include fines and other enforcement actions by the Therapeutic Goods Administration. The specific maximum penalties for these offences can vary, but they are designed to ensure compliance with the regulatory requirements and protect public health and safety.