Supply of the product Regorafenib (Stivarga) by Bayer Australia

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the supply, import, and export of therapeutic goods, including medicines, medical devices, and blood and blood components. The Act was intended to address the need for a comprehensive regulatory framework to ensure that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. The Therapeutic Goods Administration (TGA) operates under the auspices of the Department of Health to administer the Act and its related regulations. One of the policy objectives of the Act is to facilitate the timely availability of therapeutic goods that are necessary for the health of the Australian population while safeguarding public health by ensuring that only those goods that meet specific standards are approved for use. In a specific instance, on December 13, 2013, the delegate of the Secretary of the Department of Health, pursuant to the provisions of the Therapeutic Goods Act 1989, granted consent for the supply of regorafenib (STIVARGA) 40 mg tablets by Bayer Australia, despite the product not fully complying with the General requirements for labels for medicines (Therapeutic Goods Order 69). This consent was conditional, stipulating that the product be supplied with particular labelling and over-sticker information to identify the Australian sponsor and ARTG number, and was set to expire on June 13, 2014. This decision underscores the Act’s function in balancing regulatory compliance with public health needs, allowing for the controlled introduction of therapeutic goods under specific conditions.

Scope and Application

The Therapeutic Goods Act 1989, as amended and specifically referenced in this Gazette, pertains to the regulation of therapeutic goods within Australia. This legislation applies to entities such as manufacturers, importers, and suppliers of therapeutic goods, including pharmaceuticals, medical devices, and other health-related products. The Act establishes a regulatory framework aimed at ensuring the safety, quality, and efficacy of therapeutic goods available in the Australian market. In the context of this particular notice, the Act applies to Bayer Australia, which is authorised to supply the product regorafenib (STIVARGA) 40 mg tablets under specific conditions. The Act extends its jurisdictional reach across the Commonwealth of Australia, thereby encompassing all states and territories within the nation. Notably, the Act includes provisions that allow for exceptions and exemptions, and in this case, consent is granted for the supply of a product that does not conform to all labelling requirements of Therapeutic Goods Order 69, subject to the outlined conditions. The Act also provides for the extension or restriction of its application through subordinate instruments, such as therapeutic goods orders and regulations, which may further define the scope and specific requirements of therapeutic goods regulation.

Key Provisions

Section 14 of the Therapeutic Goods Act 1989 allows the delegate of the Secretary of the Department of Health to give consent for the supply of therapeutic goods that do not fully comply with the labelling requirements set out in Therapeutic Goods Order No. 69. In this specific case, section 14A authorises this consent for the supply of regorafenib (STIVARGA) 40 mg tablets by Bayer Australia, with certain conditions to ensure compliance with Australian regulations. These conditions include packaging the tablets in cartons and bottles labelled according to a specific email dated December 11, 2013, and over-sticker the cartons with information identifying the Australian sponsor and the Australian Register of Therapeutic Goods (ARTG) number. This consent, granted on December 13, 2013, is temporary and expires on June 13, 2014. The obligations imposed on Bayer Australia and any other entities involved in the supply of these therapeutic goods include adhering strictly to the conditions outlined in the consent. This means ensuring that the tablets are packaged and labelled in accordance with the specified requirements and that any over-sticker information is accurate and visible. Bayer Australia must also ensure that these conditions are met until the consent expires on June 13, 2014. Failure to comply with these obligations could result in the revocation of the consent and potential legal consequences. Under the Therapeutic Goods Act 1989, there are both civil and criminal penalties for breaches of the Act and its associated regulations. For example, contravening section 14A by supplying therapeutic goods without the required consent or failing to meet the specified conditions can result in substantial fines and, in serious cases, imprisonment. The maximum penalties for such offences are detailed in section 32AB of the Act, where the maximum penalty for an individual can be up to $330,000 or imprisonment for five years, or both, for each offence. For a body corporate, the penalties can be significantly higher, with fines reaching up to $1,650,000 for each offence. These stringent penalties underscore the importance of strict compliance with the Act’s requirements to avoid severe legal repercussions.