Supply of Elevit with Iodine by Bayer Australia Ltd

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to provide a framework for the regulation of therapeutic goods in Australia, aiming to ensure that such goods are of acceptable quality, efficacy, and safety for the public. The Act was introduced to address the need for a comprehensive regulatory system to oversee the manufacturing, supply, and advertising of therapeutic goods, which include medicines, medical devices, and blood products. This legislative framework is overseen by the Therapeutic Goods Administration (TGA), which operates under the Department of Health. The policy objective of the Act is to protect and promote public health by ensuring that therapeutic goods available in Australia meet the necessary standards for safety, efficacy, and quality. On 20 August 2013, the Delegate of the Secretary of the Department of Health and Ageing granted consent under sections 14 and 14A of the Act for Bayer Australia Ltd to supply, import, and export the therapeutic good Elevit with Iodine, identified by the Australian Register of Therapeutic Goods number (ARTG No.) 174543. The consent allowed the goods to be supplied without conforming to certain clauses of the Therapeutic Goods Order No. 78, subject to specific conditions related to the content limits of active ingredients. These conditions ensure that the therapeutic goods meet the required quality standards as outlined in Table 1 of the consent. The consent was granted for goods released for supply prior to 30 April 2014, ensuring a temporary allowance for these specific goods to be marketed under the stipulated conditions.

Scope and Application

The Therapeutic Goods Act 1989 (the Act) applies to therapeutic goods, which are regulated to ensure their safety, quality, and efficacy. In this instance, the Act applies to Bayer Australia Ltd's supply, importation, and exportation of specific therapeutic goods, namely Elevit with Iodine, as identified by the Australian Register of Therapeutic Goods number (ARTG No.) 174543. This legislation governs the conditions under which these goods may be supplied, including specific exemptions from certain clauses of the Therapeutic Goods Order 78, applicable to the goods. The consent given under section 14 and 14A of the Act is contingent upon the fulfilment of all other requirements of the standard and is subject to certain conditions and limitations, such as the date of goods released for supply prior to 30 April 2014. The Act's jurisdiction extends across the Commonwealth of Australia, encompassing federal regulatory oversight of therapeutic goods. The consent granted under the Act may also be subject to further regulation or modification through subordinate instruments, which could extend or restrict the application of the consent as deemed necessary by the Therapeutic Goods Administration.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) allows the Delegate of the Secretary of the Department of Health and Ageing to give consent for the supply, importation, and exportation of specified therapeutic goods under sections 14 and 14A (sections 14 and 14A). This consent applies to the therapeutic goods or classes of goods listed in Column 2 of the Table, which have an Australian Register of Therapeutic Goods number (ARTG No.) specified in Column 3. The consent is subject to the standard listed in Column 4, with the exception of the clauses in Column 5, and is conditional upon meeting the conditions in Column 6 for the period specified in Column 7 (section 15(1)). In this particular case, Bayer Australia Ltd has received consent to supply, import, and export Elevit with Iodine, with an ARTG No. of 174543, without adhering to certain clauses of the Therapeutic Goods Order No. 78 (TGO 78). Specifically, the consent pertains to the limits of the content of each active ingredient in the product, which must comply with the limits stated in Table 1 (Column 5 and Table 1). These conditions apply to goods released for supply before 30 April 2014 (Column 6 and Column 7). Parties governed by the Act, such as Bayer Australia Ltd, must ensure that the therapeutic goods they supply, import, or export comply with the specified conditions and standards. They must also ensure that the active ingredients' content limits comply with the stipulated percentages, as outlined in Table 1. This includes verifying that the goods meet the requirements of the TGO 78, except for the specified clauses, and that they are released for supply before the given date. Failure to comply with the conditions and standards specified in the Act and the Table may result in civil or criminal penalties. The exact penalties depend on the severity of the breach and may include fines, imprisonment, or both. Under Australian law, the maximum penalties for offences involving therapeutic goods can vary significantly. For example, the maximum penalty for supplying therapeutic goods that do not comply with the standards can be up to $2,200,000 for a corporation and/or imprisonment for up to 10 years (section 32DA). Additionally, individuals responsible for the breach may face personal fines and imprisonment.