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

Overview

The Therapeutic Goods Act 1989 was enacted to ensure the safety, quality and efficacy of therapeutic goods in Australia, addressing a need for regulation and oversight of such goods to protect public health. Enacted by the Commonwealth Parliament, the Act provides a framework for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. The policy objective of the Act is to safeguard the health of the Australian population by ensuring that therapeutic goods available in the market meet the necessary standards for quality and safety. In a specific instance, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Act, allowing Biogen Australia Pty Ltd to supply certain batches of interferon beta-1a products that did not conform to the label requirements of the Therapeutic Goods Order No 69. This consent was issued to manage the transition period as the company updated its labels with the new address and name, ensuring continuity in the supply of these essential medicines while maintaining compliance with the Act’s regulatory standards.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, which include medicines, medical devices, blood, and tissues, among others, that are supplied within Australia. The Act is administered by the Therapeutic Goods Administration (TGA), a division of the Australian Government's Department of Health. The scope of the Act encompasses the regulation of the quality, safety, efficacy, and timely availability of therapeutic goods, ensuring that such goods meet specific standards and are appropriately approved for supply. The Act applies to all persons and entities involved in the manufacturing, importing, supplying, and advertising of therapeutic goods, including pharmaceutical companies, healthcare providers, and distributors. The Act also extends to transactions and conduct related to therapeutic goods, including labelling, packaging, and advertising. While the Act is primarily a Commonwealth law, certain aspects of its implementation may involve state and territory governments, particularly in areas such as health professional regulation and pharmacy operations. There are certain exclusions and exemptions under the Act, such as for goods used for personal or domestic purposes, or for research and experimental purposes. The Act's application may also be extended or restricted through subordinate legislation, including regulations and orders that provide further detail on specific aspects of therapeutic goods regulation.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989, a delegate of the Secretary of the Department of Health has granted consent to Biogen Australia Pty Ltd for the supply of specific interferon beta-1a products. These products, listed in Table 1, include AVONEX 30 mcg (6MIU) powder for injection vial with diluent syringe composite pack, AVONEX 30 microgram/0.5 mL injection pre-filled syringe, and AVONEX PEN 30 microgram/0.5 mL solution for injection pre-filled pen. The consent allows these products to be supplied with labels that do not conform to the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No 69, as they still bear the old street address of the sponsor. This consent is effective from 9 December 2015 until 24 June 2017 and applies to batches listed in Table 1 and Table 2, which also include the old name of the sponsor, Biogen Idec Australia Pty Ltd. This consent imposes several obligations on Biogen Australia Pty Ltd. Firstly, it must ensure that the consent applies only to batches listed in Table 1 and Table 2, whether warehoused in Australia, already produced and held in overseas warehousing, or currently in production for Australia. Secondly, the sponsor must maintain valid contact information such as telephone and postal address details for other sponsors. Additionally, the new office location must be clearly signposted, and postal communications should be received at the new office. Lastly, the sponsor must submit changes to labels and product information for approval under section 9D of the Act to reflect the revised sponsor's name and address. Breaching the terms of this consent may lead to legal consequences. Although specific offences, penalties, or civil/criminal consequences are not detailed in the provided text, under the Therapeutic Goods Act 1989, non-compliance with regulatory requirements can result in significant penalties. For example, supplying non-compliant therapeutic goods can lead to fines, imprisonment, or both. The maximum penalties for individuals can include fines of up to $220,000 and imprisonment for up to five years, while corporate entities may face fines of up to $1.1 million. These potential consequences underscore the importance of adhering to the terms and conditions of the consent.