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

Overview

The Therapeutic Goods Act 1989, enacted to regulate therapeutic goods in Australia, including medicines, medical devices, and blood, aims to protect public health by ensuring these goods are safe, of high quality, and perform as claimed. The Act was introduced to address the need for a comprehensive regulatory framework governing the manufacture, supply, and advertising of therapeutic goods to ensure they meet safety and quality standards. In September 2014, the delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Act to AbbVie Pty Ltd for the importation and supply of palivizumab (SYNAGIS), despite the labels not conforming to specific labelling requirements. This consent, subject to conditions ensuring continuity of services and communication, highlights the Act's objective to balance regulatory compliance with public health needs.

Scope and Application

The Therapeutic Goods Act 1989, under sections 14 and 14A, applies to the regulation and control of therapeutic goods in Australia. This encompasses a broad range of products including medicines, medical devices, blood, and tissues, which are intended for use in the diagnosis, treatment, mitigation, or prevention of a disease, abnormality, or injury in humans or animals. The Act applies to entities such as manufacturers, importers, suppliers, and sponsors of these therapeutic goods, as well as individuals involved in their distribution and use. The jurisdictional reach of the Act is national, as it is a Commonwealth Act, applying across all states and territories of Australia. The Act allows for the granting of consents for therapeutic goods that do not conform to specified standards or requirements, subject to certain conditions to ensure public health and safety are not compromised. These consents can extend the application of the Act through subordinate instruments, ensuring flexibility and responsiveness to specific circumstances while maintaining the overarching legislative framework. In the specific case of the consent granted to AbbVie Pty Ltd for the importation and supply of palivizumab (SYNAGIS) on September 25, 2014, the consent is subject to particular conditions aimed at maintaining continuity in service and communication despite a change in the sponsor’s address. This consent, effective from September 25, 2014, until September 1, 2016, is an example of how the Therapeutic Goods Act can be applied to accommodate specific situations while ensuring the integrity of the regulatory framework. The Act’s provisions allow for such exceptions, provided they are strictly regulated and monitored to uphold the standards set for therapeutic goods in Australia.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") contains various provisions that govern the regulation of therapeutic goods in Australia. Sections 14 and 14A of the Act, in particular, provide for the delegate of the Secretary of the Department of Health to give consent for the importation and supply of therapeutic goods that do not fully comply with the standards set out in the Therapeutic Goods Orders. This consent can be granted under certain conditions. In this case, AbbVie Pty Ltd applied for and was granted consent under section 14 and 14A of the Act for the importation and supply of palivizumab (SYNAGIS) powder for injection, a medicine used for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants. The primary requirement of this consent, as outlined in the Gazette, is that the labels for the supplied products must contain the previous address of the sponsor or supplier, 32-34 Lord St, Botany, NSW 2019. This requirement is imposed because the labels on the containers and primary packs of the products do not conform to the requirements of clause 3(2)(l) of the Therapeutic Goods Order No. 69, which mandates that labels must not contain any information that is false, misleading or likely to create an erroneous impression about any matter. The sponsor or supplier must ensure that the specified address is included on the labels, even though it is no longer the current address. The obligations imposed on the parties by this consent are primarily administrative in nature. The sponsor or supplier must ensure that the correct labels are supplied, which includes the previous address of the sponsor. Additionally, arrangements must be made to forward any material sent to the old address to the current sponsor address. This includes ensuring that services such as medical information, customer enquiries, pharmacovigilance activities, and customer complaints are not disrupted during this transition period. Contingency plans must also be put in place to ensure that any communications intended for the old address are redirected to the new address. Failure to comply with the conditions of this consent could result in legal consequences. Under the Act, breaches of the conditions of consent may lead to enforcement actions by the Therapeutic Goods Administration, which could include fines, product recalls, or legal proceedings. While the Gazette does not specify the maximum penalties for breaches of this consent, the Therapeutic Goods Act provides for penalties of up to $1,650,000 for companies and $330,000 for individuals for breaches of the Act and its regulations. It is crucial for the sponsor or supplier to adhere to the conditions to avoid such consequences.