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

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the supply and quality of therapeutic goods, including medicines, medical devices, and blood products, in Australia. The Act was established to address issues related to the safety, efficacy, and quality of therapeutic goods available to the public. The Therapeutic Goods Administration, an agency of the Department of Health, administers the Act. This legislative framework aims to ensure that therapeutic goods meet the necessary standards and are appropriately controlled to protect public health. The Act provides the authority for the Therapeutic Goods Administration to regulate therapeutic goods, including the issuance of consents under sections 14 and 14A to allow certain deviations from regulatory requirements in specific circumstances. On 17 August 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to Shire Australia Pty Ltd, permitting the supply of a specific batch of esterase inhibitor (CINRYZE C1) that did not conform to certain labelling requirements. This consent was issued to address the transitional period following the transfer of sponsorship from Viropharma Pty Ltd to Shire Australia Pty Ltd. The consent allowed the continued supply of the product with existing labels bearing the former sponsor's details, pending the submission of updated labels to the Therapeutic Goods Administration. The consent was effective from 17 August 2015 until 31 December 2016 and was subject to conditions aimed at ensuring the continued safety and quality of the therapeutic goods supplied to the public.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of therapeutic goods, including medicines, medical devices, and blood and blood components, as well as activities such as the advertising, supply, and export of these goods. This Act is enforced by the Therapeutic Goods Administration, which operates at a Commonwealth level. It applies to any person or entity involved in the manufacture, importation, supply, or advertisement of therapeutic goods within Australia. This encompasses individuals, businesses, and any organisation or entity that engages in activities related to therapeutic goods, regardless of their location within Australia. While the Act generally applies without exclusion, certain therapeutic goods or activities may be exempt from some provisions under specific conditions, such as research and development activities under certain circumstances or goods for personal use. The Act's application can also be extended or restricted through subordinate legislation, such as regulations and orders, which provide detailed specifications and standards for various aspects of therapeutic goods oversight.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) play a crucial role in allowing for the temporary supply of therapeutic goods that do not fully comply with certain legislative requirements, subject to specific conditions. Under section 14, the Secretary of the Department of Health, or a delegate, can consent to such supply on the application of a sponsor. In the case of Shire Australia Pty Ltd, their application was accepted, permitting the supply of CINRYZE C1, an esterase inhibitor, which has existing artwork labels bearing the former sponsor's details, Viropharma Pty Ltd, despite the sponsorship transfer to Shire Australia Pty Ltd. Section 14A outlines the terms and conditions under which this consent is granted. The obligations imposed by the Act on the parties governed by these sections include ensuring that the supply of non-compliant therapeutic goods is strictly controlled and transparent. Shire Australia Pty Ltd must make arrangements for prompt referral of any queries or complaints concerning the product to the new sponsor. Additionally, they must submit an application to the Therapeutic Goods Administration to update the labels with their details as soon as possible. They also need to provide assurance that no other changes have been made to the product aside from the sponsor details. Failure to comply with the conditions set out in the consent or the obligations imposed by the Act can result in significant legal consequences. While the specific penalties for breaches are not detailed in the provided text, under the Therapeutic Goods Act 1989, non-compliance can generally lead to civil and criminal penalties. These may include fines, imprisonment, or both, depending on the severity and intent behind the breach. The Act also provides for the possibility of product recalls, which can further damage the reputation and operations of the non-compliant party.