Supply of the product Palifermin by A Menarini Australia

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply and use of therapeutic goods within Australia, aiming to protect public health by ensuring that such goods are of acceptable quality, safety, and efficacy. The Act establishes a framework for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components, by setting out requirements for their manufacture, importation, supply, and advertising. The Therapeutic Goods Administration (TGA), a branch of the Department of Health, is responsible for administering the Act, with the overarching policy objective of safeguarding public health by ensuring that therapeutic goods available in Australia meet rigorous standards. In the context of the Therapeutic Goods Act 1989, the TGA has the authority to issue consents for the supply of therapeutic goods that do not fully comply with certain legislative requirements, subject to specific conditions. This power is exercised to facilitate access to necessary treatments while mitigating potential risks, as illustrated by the consent granted for the supply of the product palifermin (rbe) KEPIVANCE, which does not conform with the Therapeutic Goods Order No. 69—General requirements for labels for medicines. The consent stipulates conditions such as the use of UK packaging and the requirement for additional labelling and reporting to ensure the safety and quality of the therapeutic goods supplied.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a broad range of products including medicines, medical devices, and blood and blood components. The Act applies to individuals, companies, and other entities involved in the supply, advertising, and manufacture of therapeutic goods within Australia, as well as to imported goods. The jurisdictional reach of the Act is national, overseen by the Therapeutic Goods Administration (TGA), which is part of the Commonwealth Department of Health. Exclusions and exemptions are specified in various parts of the Act and its subordinate instruments, such as the Therapeutic Goods Orders (TGOs), which detail specific requirements for different classes of therapeutic goods. For instance, certain low-risk medical devices may be exempt from more stringent requirements if they meet specified criteria. Additionally, the Act may extend its application through subordinate instruments such as regulations and orders, which provide further detail on specific aspects of therapeutic goods regulation, including labelling, advertising, and clinical trials.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the supply of therapeutic goods in Australia, including the regulation of medicines. Section 14 and 14A of the Act are particularly relevant to the supply of certain medicines that do not conform with the Therapeutic Goods Orders (TGO). In this case, the delegate of the Secretary of the Department of Health has given consent for the supply of the product palifermin (rbe) KEPIVANCE 6.25 mg powder for injection vial, which does not conform with TGO 69, but is subject to specific conditions (Section 14(1), 14A(1)). Under these sections, the supply of KEPIVANCE is restricted to the specific UK packaging provided in the application to the TGA on February 27, 2014. Additionally, a sticker with Australian sponsor details and the Australian Register of Therapeutic Goods (ARTG) number must be affixed to the packaging, and an Australian Product Information (PI) must be supplied with each box (Section 14(2)). The sponsor is also required to inform the TGA in writing every 12 months about the number of patients treated with KEPIVANCE in the previous 12 months. This information should be sent to biological.medicines@tga.gov.au, unless an alternative arrangement has been agreed upon with the TGA (Section 15(1)). The consent for the supply of KEPIVANCE is conditional and will remain in effect until certain events occur. These include an increase in the number of patients treated with KEPIVANCE above 35 per calendar year, the listing of the medicine on the Pharmaceutical Benefits Scheme (PBS), or approval for an extension of indication. If any of these events happen, the sponsor must promptly inform the TGA in writing (Section 15(1)). Failure to comply with the conditions set forth in the Act can lead to significant consequences. Breaches of the Act may result in civil or criminal penalties. Under the Act, civil penalties can include fines up to a substantial amount, depending on the severity of the breach. In addition, criminal penalties may apply, with potential fines and imprisonment for serious or repeated offences. The specific penalties are outlined in other sections of the Act, and the exact amount of the penalties can vary based on the nature and extent of the violation (Sections 122-124). It is essential for the parties involved to adhere to the requirements and conditions to avoid these legal repercussions.