Supply of products by Baxter Healthcare Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. This legislation was introduced to address the need for comprehensive regulation of therapeutic products to protect public health. The Act was passed by the Australian Parliament, with its primary policy objective being to ensure that therapeutic goods available in the market are safe and of high quality. In 2013, the delegate of the Secretary of the Department of Health and Ageing granted specific consent for Baxter Healthcare Pty Ltd to supply certain products that did not fully comply with labelling requirements under Therapeutic Goods Order (TGO) 69. This consent was provided under sections 14 and 14A of the Act and came with conditions, including an expiration date of June 13, 2018. The consent allowed for the supply of the products in question despite their non-compliance with the labelling stipulations, ensuring that public health was still safeguarded within the set parameters.

Scope and Application

The Therapeutic Goods Act 1989, particularly sections 14 and 14A, applies to entities involved in the supply of therapeutic goods within Australia. In this instance, the Act permits Baxter Healthcare Pty Ltd, a company located in Toongabbie, NSW, to supply specific products that do not conform with certain labelling requirements outlined in Therapeutic Goods Order (TGO) 69. This authorisation is issued by the delegate of the Secretary of the Department of Health and Ageing and is geographically confined to the Commonwealth of Australia. The consent granted is specifically for the supply of thrombin – human and calcium chloride (TISSELL VH S/D) and thrombin and calcium chloride (ARTISS FIBRIN SEALANT VH S/D), which are intended for use as fibrin sealants. The consent is subject to conditions set by the Act, and it expires on June 13, 2018, after which the products must comply with the stipulated labelling requirements. No other changes to the products are permitted during this period.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the "Act") pertain to the supply of therapeutic goods that do not conform to the Australian Register of Therapeutic Goods (ARTG). Section 14 allows the Secretary of the Department of Health and Ageing to give consent for the supply of such goods, while Section 14A sets out conditions under which this consent is granted. In this instance, the delegate of the Secretary has given consent for the supply of two specific products by Baxter Healthcare Pty Ltd, namely thrombin – human and calcium chloride (TISSELL VH S/D) and thrombin and calcium chloride (ARTISS FIBRIN SEALANT VH S/D). This consent is specifically tied to the products not meeting the labelling requirements set out in Therapeutic Goods Order (TGO) 69, which mandates a statement of the intended purpose of the good on the label. The obligations imposed by the Act on the parties involved include strict compliance with the conditions set by the Secretary. Baxter Healthcare Pty Ltd must ensure that the supplied products adhere to the consent conditions, particularly the labelling requirements. The company must also ensure that no other changes are made to the products beyond what has been specified in the consent. The Secretary, on the other hand, has the responsibility to monitor compliance with the conditions and can revoke the consent if any breach occurs. Failure to comply with the conditions outlined in the consent can lead to various consequences. The Act provides for both civil and criminal penalties for breaches. For civil penalties, the maximum fines can be substantial, with the exact amount depending on the severity and nature of the breach. Criminal penalties may also apply, particularly if the breach is deemed to have caused harm to consumers. Additionally, non-compliance can result in the revocation of the consent, which would cease the authorised supply of the products in question. This underscores the importance of adhering to the stipulated conditions to avoid legal ramifications.