Supply of Oseltamivir (Tamiflu) capsules by Roche Products Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to provide a framework for regulating therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This legislation fills a critical gap by establishing the regulatory mechanisms needed to manage the approval, supply, and monitoring of therapeutic goods, which include medicines, medical devices, and other health-related products. The Act aims to protect public health by ensuring that only therapeutic goods that meet the necessary standards are available for use. The Therapeutic Goods Administration (TGA), as the delegate of the Secretary of the Department of Health, exercises powers under the Act to issue consents for the supply of therapeutic goods that may not fully comply with specific regulatory standards. The policy objective of the Act is to maintain and improve the health of Australians by ensuring that therapeutic goods are of acceptable quality and safe for use. The legislative framework allows for flexibility in exceptional circumstances, such as public health emergencies, to ensure the availability of necessary therapeutic goods while maintaining the overarching goal of protecting public health.

Scope and Application

The Therapeutic Goods Act 1989, specifically Sections 14 and 14A, governs the regulation of therapeutic goods in Australia, ensuring they meet required standards of quality, safety, and efficacy. This Act applies to entities and individuals involved in the supply, manufacture, or importation of therapeutic goods, including Roche Products Pty Ltd in this instance. The geographic reach of the Act is national, extending throughout the Commonwealth of Australia and ensuring uniform regulation across all states and territories. The Act allows for certain exclusions and exemptions, but in this particular case, the consent granted by the delegate of the Secretary pertains to Roche Products Pty Ltd supplying specific products that do not meet the stipulated shelf life requirements as per Therapeutic Goods Order (TGO) 69. However, under Section 15(1) of the Act, consent is provided subject to specific conditions, allowing the indefinite supply of these products despite their non-compliance with the expiry date stipulations of TGO 69. The Act’s scope can be extended or restricted through subordinate instruments, allowing for flexibility in responding to emerging issues or new scientific evidence.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the supply of therapeutic goods in Australia, and the main operative sections relevant to this notice involve the granting of consent for the supply of products that do not conform with certain standards. Specifically, under sections 14 and 14A, the delegate of the Secretary of the Department of Health has provided consent for Roche Products Pty Ltd to supply certain products of oseltamivir (TAMIFLU) that do not meet the requirements set out in Therapeutic Goods Order (TGO) 69. This consent is granted despite the fact that the shelf life of these products is 10 years, which exceeds the 5-year limit specified in TGO 69. The obligations and requirements imposed by this legislation are primarily centred around ensuring the safety and efficacy of therapeutic goods supplied in Australia. The Therapeutic Goods Administration (TGA) has the authority to assess applications for consent to supply non-compliant products and to impose conditions to mitigate any potential risks. In this case, the delegate has granted consent subject to the condition that no other changes are made to the specified products, and the consent applies indefinitely. This means that Roche Products Pty Ltd can continue to supply the specified products under these conditions, provided they adhere to all other relevant requirements of the Act. There are potential civil and criminal consequences for breaches of the Therapeutic Goods Act 1989. Any party found to be in breach of the Act, including supplying non-compliant therapeutic goods, may face substantial penalties. Under section 92 of the Act, an individual can be fined up to $66,000 for a strict liability offence, while a body corporate can be fined up to $330,000. Additionally, supplying a therapeutic good that does not comply with the standards could lead to criminal charges, resulting in imprisonment for up to 5 years for an individual or a fine of up to $1,650,000 for a body corporate. These penalties highlight the importance of compliance with the Act and the potential consequences of non-compliance.