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

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the import, export, and supply of therapeutic goods in Australia, aiming to protect public health by ensuring that only safe and effective products are available. The Act was introduced to address the need for a comprehensive legislative framework governing therapeutic goods, including medicines, medical devices, and other related products, to ensure they meet quality, safety, and efficacy standards. This legislation empowers the Therapeutic Goods Administration (TGA), under the Department of Health, to enforce compliance and manage the risks associated with therapeutic goods through various mechanisms, including consent to importation and supply of non-compliant products under certain conditions. The policy objective of the Act is to safeguard public health by maintaining high standards for the therapeutic goods market in Australia. On 26 November 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 Abbvie Pty Ltd for the importation and supply of VIEKIRA PAK, a combination of paritaprevir/ritonavir/ombitasvir and dasabuvir tablets, which did not conform to certain labelling requirements specified in the Therapeutic Goods Order No. 69. The consent allowed for the importation and supply of the product with specific conditions, including the provision of corrected 'daily wallet' labels and a 'Dear Healthcare Provider/Pharmacist' letter to address the non-compliance issues identified. This consent was effective from 26 November 2015 until 31 July 2016, providing a temporary solution to ensure the availability of the therapeutic product while addressing regulatory concerns.

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, blood and blood components, and therapeutic appliances. The Act applies to persons and entities involved in the supply, importation, and advertising of therapeutic goods, ensuring that these goods meet safety, quality, and efficacy standards. It extends to the entire Commonwealth of Australia, providing a unified regulatory framework for therapeutic goods across all states and territories. The Act's application can be extended or modified through subordinate instruments, such as regulations and orders, which provide further detail on specific aspects of therapeutic goods regulation. However, certain products and activities may be excluded or exempt under the Act, such as goods for personal use or research purposes, which are not intended for commercial supply. Additionally, the Act includes specific provisions for certain types of therapeutic goods, such as biologicals and complementary medicines, which may have different regulatory requirements. In the case of the consent granted under sections 14 and 14A of the Therapeutic Goods Act 1989, the Act allows the Therapeutic Goods Administration to permit the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements, provided that the non-compliance does not pose an unacceptable risk to public health and safety. In this instance, the consent was granted to Abbvie Pty Ltd for the importation and supply of VIEKIRA PAK, a combination of medicines used to treat chronic hepatitis C, which did not conform to specific labelling requirements. The consent was subject to specific conditions, including the provision of certain information to healthcare providers, to ensure that the public was adequately informed about the product and its use. The consent was effective for a limited period, until 31 July 2016, and did not alter the underlying regulatory requirements for the product.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) plays a pivotal role in regulating therapeutic goods in Australia. Sections 14 and 14A of the Act allow the Secretary of the Department of Health to consent to the importation and supply of therapeutic goods that do not conform to certain requirements if the sponsor makes an application. This was exemplified in the case of VIEKIRA PAK paritaprevir/ritonavir/ombitasvir 75 mg/50 mg/12.5 mg tablets and dasabuvir (as sodium salt) 250 mg tablets composite pack blister pack [AUST R 224612], which was imported and supplied by Abbvie Pty Ltd. The consent granted under these sections was specific to the non-compliance with certain labelling requirements set out in Therapeutic Goods Order No. 69 (TGO 69). Under sections 14 and 14A, the main requirement is that any non-compliance with labelling or other specified requirements must be supported by an application from the sponsor. In this case, Abbvie Pty Ltd applied for consent to import and supply VIEKIRA PAK, despite the product's labels not meeting the standards stipulated in paragraphs 3(2)(a), (l) and (j) of TGO 69. These paragraphs generally relate to the product name, sponsor's address, and storage conditions, respectively. The consent allowed the importation and supply of the product with these specific non-compliant labels for a defined period, from 26 November 2015 until 31 July 2016. The Act imposes several obligations on parties importing and supplying therapeutic goods. In this instance, Abbvie Pty Ltd had to ensure that certain conditions were met to facilitate the consent. These conditions included providing specific 'daily wallet' labels as submitted in response to section 31 requests PM-2014-01436-1-2 and PM-2014-01438-1-2, and supplying a 'Dear Healthcare Provider/Pharmacist' letter to healthcare providers with patients enrolled in the sponsor's VIEKIRA PAK supply program. These conditions were designed to mitigate any potential risks associated with the non-compliant labels. Failure to comply with the provisions of the Therapeutic Goods Act 1989 can result in serious consequences. Under the Act, breaches can lead to both civil and criminal penalties. Civil penalties may include fines, while criminal penalties can result in imprisonment, fines, or both, depending on the severity of the breach. The maximum penalties for offences under the Act are specified in the legislation and can vary significantly based on the nature and extent of the non-compliance. It is important for parties governed by the Act to adhere strictly to the requirements to avoid these potential penalties.