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

Overview

The Therapeutic Goods Act 1989, enacted in 1989, was introduced to regulate therapeutic goods, including medicines, in Australia, ensuring that they are safe, of high quality, and effective. The Act is overseen by the Therapeutic Goods Administration, an agency of the Commonwealth of Australia’s Department of Health. This legislation aims to address gaps in the regulation of therapeutic goods by providing a comprehensive framework for their approval, quality control, and monitoring. On 29 June 2015, the delegate of the Secretary of the Department of Health gave consent to the importation and supply of specific batches of Fampyr® (fampridine) modified release tablets, which did not conform to certain labelling requirements. This consent was granted under the Act's provisions to ensure the availability of necessary therapeutic goods while maintaining regulatory standards. The policy objective behind this consent was to allow for the continued supply of an important medicine to patients, while ensuring compliance with the Act’s requirements as closely as possible.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medicines, medical devices, blood, tissues, and other related products within the Australian jurisdiction. This Act is administered by the Therapeutic Goods Administration (TGA), an agency of the Australian Government's Department of Health. The Act covers manufacturers, importers, suppliers, and sponsors of therapeutic goods, as well as the conduct and transactions related to these goods. The legislation has a national reach, governing activities across all states and territories of Australia. The Act sets out provisions for the regulation of therapeutic goods to ensure their safety, quality, and efficacy, and it includes various exclusions and exemptions for certain products and activities, such as those under research and development or those intended for personal use. Subordinate instruments, such as regulations and orders, further extend or restrict the application of the Act by detailing specific requirements and standards for different categories of therapeutic goods. In the context of the gazetted notice issued on 29 June 2015, the Therapeutic Goods Act 1989 provided the framework under which consent was granted for the importation and supply of specific batches of Famprydine (FAMPYRA) modified release tablets, despite the labels not conforming to the current registered sponsor name. This consent, issued under the authority of the Secretary of the Department of Health, is subject to conditions that ensure the product's labels remain those currently approved for the product. This demonstrates how the Act allows for flexibility in certain circumstances, while maintaining strict oversight to protect public health.

Key Provisions

The main operative sections of the Therapeutic Goods Act 1989, specifically sections 14 and 14A, provide the legal basis for the Therapeutic Goods Administration to grant consent for the importation and supply of therapeutic goods that do not conform with certain requirements. In this instance, section 14(1) allows the delegate of the Secretary to consent to the importation and supply of therapeutic goods if they do not meet the regulatory requirements, and section 14A allows for this consent to be given subject to specific conditions. Under these sections, the delegate of the Secretary granted Biogen Australia Pty Ltd consent to import and supply specific batches of the modified release tablet 10 mg of fampridine (FAMPYRA), which do not conform with the label requirements set out in the Therapeutic Goods Order No. 69. The Act imposes specific obligations and requirements on both the Therapeutic Goods Administration and the entities seeking consent. The delegate of the Secretary, acting on behalf of the Secretary, must carefully review applications and ensure that any consent granted is appropriate and subject to conditions that mitigate any risks associated with the non-compliance. For Biogen Australia Pty Ltd, this includes adhering to the conditions specified by the delegate of the Secretary, such as ensuring that the labels used for the product are those currently approved and do not present any misleading information to consumers. The conditions also require compliance with all other applicable provisions of the Therapeutic Goods Act and associated regulations. Failure to comply with the conditions set out in the consent, or any other requirements of the Therapeutic Goods Act, may result in significant consequences. Under section 32 of the Act, offences related to the non-compliance can result in substantial penalties. For individuals, the maximum penalty can be up to 500 penalty units, which as of 2023, equates to approximately AUD 57,500. For bodies corporate, the penalties can be significantly higher, reaching up to 5,000 penalty units, which equates to approximately AUD 575,000. Additionally, there may be civil consequences such as fines or the imposition of injunctions, as well as criminal penalties which can include imprisonment for serious offences. It is therefore crucial for all parties involved to adhere strictly to the terms of the consent and the broader regulatory framework.