Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified - between 25 September 2014 and 1 September 2016

Overview

The Therapeutic Goods Act 1989 was enacted by the Australian Parliament to regulate the importation, supply, and manufacturing of therapeutic goods within Australia. The legislation aims to ensure that therapeutic goods available in Australia meet standards of quality, safety, and efficacy. In September 2014, the delegate of the Secretary of the Department of Health issued a notice under sections 14 and 14A of the Act, granting AbbVie Pty Ltd consent for the importation and supply of specific formulations of adalimumab, a therapeutic product, despite non-compliance with certain labelling requirements. The consent was granted for a period from 25 September 2014 to 1 September 2016 and was made subject to conditions ensuring the continuity of services and communication with the sponsor, despite the change in the sponsor's address. This intervention was aimed at facilitating the availability of necessary therapeutic goods to patients while addressing compliance issues in a controlled manner.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products including medicines, medical devices, and blood and blood components. The Act applies to entities and persons involved in the supply, importation, and manufacture of therapeutic goods within Australia, ensuring that such goods meet the required standards of quality, safety, and efficacy. The legislation has a national reach, governing activities across the Commonwealth, states, and territories in Australia. The Act includes provisions for the issuance of consents and exemptions for certain therapeutic goods under specific circumstances, such as the case presented where the Therapeutic Goods Administration has granted consent for the importation and supply of adalimumab products by AbbVie Pty Ltd, which do not conform to certain labelling requirements. The consent is subject to conditions that ensure continuity in the provision of services related to the therapeutic goods, thereby maintaining compliance and consumer protection standards. Section 14 and 14A of the Act facilitate the granting of consents for therapeutic goods that do not fully comply with the specified regulatory requirements, provided that such non-compliance does not pose a significant risk to public health or safety. The geographic scope of the Act is comprehensive, covering all therapeutic goods distributed within Australia, irrespective of whether they are sourced domestically or internationally. The Act also provides for the possibility of extending its application through subordinate instruments, such as therapeutic goods orders and regulations, which further detail and specify the regulatory requirements for different classes of therapeutic goods. These subordinate instruments can include specific labelling, manufacturing, and distribution standards, ensuring a cohesive and uniform approach to the regulation of therapeutic goods across the country.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 (the Act) provide the Secretary of the Department of Health with the authority to issue consent for the importation and supply of therapeutic goods that do not conform to certain regulatory requirements. In this instance, AbbVie Pty Ltd applied for, and received, consent for the importation and supply of several adalimumab products that do not comply with the labelling requirements outlined in Therapeutic Goods Order No. 69. Specifically, the labelling for these products includes the previous address of the sponsor, which is not in line with the current regulatory standards. The consent granted under Section 14A of the Act is subject to certain conditions outlined by the Secretary's delegate. These conditions include ensuring that all labels supplied contain the previous address of the sponsor, which is 32-34 Lord St, Botany, NSW 2019. Additionally, the consent stipulates that arrangements must be in place to forward any materials sent to the previous Botany address to the current sponsor address. Furthermore, AbbVie Pty Ltd must maintain the provision of services such as medical information, customer enquiries, pharmacovigilance activities, and customer complaints, with contingencies in place to ensure any communications with the previous address are properly forwarded to the new address. The obligations imposed on AbbVie Pty Ltd by this consent are primarily focused on ensuring compliance with the specified conditions. This includes using labels that include the previous address of the sponsor, implementing forwarding arrangements for materials sent to the old address, and maintaining the provision of specified services while ensuring that all communications are appropriately redirected. These obligations are designed to mitigate any potential issues that might arise from the non-compliance of the product labelling with the Therapeutic Goods Order No. 69. Failure to adhere to the conditions specified in the consent may result in legal consequences. Although the Act itself does not specify penalties for non-compliance with the consent conditions, breaches of other sections of the Act can lead to significant penalties. For example, under Section 33 of the Act, supplying therapeutic goods that do not comply with the standards set out in the Therapeutic Goods Orders can result in civil penalties of up to $22,200 per breach for individuals and $111,000 per breach for corporations. Additionally, under Section 34, supplying goods that are unsafe can result in criminal penalties, including fines of up to $1,110,000 and imprisonment for up to five years for individuals, and fines of up to $5,550,000 and imprisonment for up to five years for corporations. These potential penalties underscore the importance of strict compliance with the conditions set out in the consent and the broader regulatory requirements of the Therapeutic Goods Act 1989.