Supply of the product Adacel Pertussis Vaccine by Sanofi-Aventis Australia

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the importation, supply, and other aspects of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. This legislation was introduced to address the need for a comprehensive regulatory framework to govern the therapeutic goods industry, protecting public health by controlling the supply and quality of these goods. The Act was passed by the Commonwealth Parliament with the policy objective of ensuring that therapeutic goods available in Australia meet acceptable standards of quality and performance, and that their benefits outweigh any risks associated with their use. The Therapeutic Goods Administration (TGA) is the body responsible for administering the Act and enforcing its provisions to safeguard the health of Australians. In February 2014, the delegate of the Secretary of the Department of Health granted an exemption under the Therapeutic Goods Act 1989 for the supply of a specific batch of Adacel pertussis vaccine by Sanofi-Aventis Australia Pty Ltd. This exemption allowed for the supply of the vaccine with an international vial label that did not conform to certain requirements of Therapeutic Goods Order (TGO) 69. The exemption was granted subject to specific conditions, including the use of an Australian carton label and patient information leaflet, and compliance with all other conditions for the importation and supply of the vaccine. This decision highlights the TGA's role in balancing regulatory requirements with the need to facilitate access to essential medicines under certain circumstances.

Scope and Application

The Therapeutic Goods Act 1989, as amended and applied in this context by the Therapeutic Goods Administration (TGA), governs the regulation of therapeutic goods in Australia. Specifically, under sections 14 and 14A, the Act allows for exemptions from certain regulatory requirements to facilitate the supply of therapeutic goods in particular circumstances. In this instance, the Act applies to the supply of ADACEL pertussis vaccine-acellular combined with diphtheria and tetanus toxoids [adsorbed] 0.5 mL injection vial, a product manufactured by Sanofi-Aventis Australia Pty Ltd. The exemption provided by the Secretary’s delegate pertains only to Batch No C4209AL of this vaccine, which is packaged in an Australian carton label and supplied with an Australian Product Information leaflet, while the international vial label does not conform to certain specifications outlined in Therapeutic Goods Order (TGO) 69. This exemption is narrowly tailored to this specific batch and product, and the exemption conditions strictly outline that all other regulatory requirements must still be met. The geographic reach of this Act is national, applying uniformly across Australia and overseen by the Commonwealth through the TGA. There are no stated exclusions beyond the specific conditions of this exemption, and it is not extended or restricted further by subordinate instruments in this particular case.

Key Provisions

The Therapeutic Goods Act 1989 (section 14 and 14A) includes provisions that allow the delegate of the Secretary of the Department of Health to give consent for certain products to be supplied despite not fully complying with specific regulatory requirements. In this instance, the delegate has consented to the supply of the ADACEL pertussis vaccine-acellular combined with diphtheria and tetanus toxoids [adsorbed] 0.5 mL injection vial [AUST R 106554] by Sanofi-Aventis Australia Pty Ltd, despite the international vial label not conforming with paragraphs 3(2)(b) and 3(2)(c) of Therapeutic Goods Order (TGO) 69 (subsection 15(1)). This consent is specifically limited to Batch No C4209AL and requires the vaccine to be packaged in an Australian carton label and supplied with an Australian Product Information leaflet. The obligations imposed by the Act on the parties involved, particularly the Company, include ensuring that the vaccine is packaged and labelled according to the specified Australian standards, notwithstanding the non-compliance of the international vial label. The Company must also adhere to all other conditions for the importation and supply of this particular batch as outlined in the Act. This includes maintaining proper documentation and ensuring that the product meets all other safety and quality standards applicable under the Act. Breaching the conditions set forth in the consent could result in various civil or criminal consequences. While specific offences and penalties are not detailed in the provided text, general provisions within the Therapeutic Goods Act 1989 may include fines, imprisonment, or other penalties for non-compliance with therapeutic goods regulations. The exact penalties can vary depending on the severity and nature of the breach, but they are typically substantial to ensure compliance with health and safety standards.