Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Australian Red Cross Blood Service

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, addresses issues related to the regulation of therapeutic goods in Australia, including medicines, medical devices, blood, and blood components. This Act was introduced to ensure the safety, quality, and efficacy of therapeutic goods available in the market and to protect public health. Under sections 14 and 14A of the Act, a delegate of the Secretary of the Department of Health granted consent to the Australian Red Cross Blood Service to supply blood and blood components that deviate from the age limits specified by the Council of Europe. This consent was provided to accommodate the collection of blood and blood components from donors aged between 60 and 80 years, without requiring medical review, based on the absence of evidence suggesting the exclusion of older donors and the reliance on skilled in-person interviews for donor selection. The consent is effective until 28 July 2020 and aims to provide flexibility in the blood donation process while maintaining safety standards. The Therapeutic Goods Administration, operating under the Department of Health, is responsible for enforcing the Act and ensuring compliance with its provisions. The policy objective underpinning this consent is to optimise the availability of blood and blood components for medical use while balancing safety concerns, recognising that there is no substantial evidence to exclude older donors and that the in-person interview process adequately safeguards donor health. This legislative action reflects a pragmatic approach to addressing supply needs while upholding rigorous health standards.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medicines, medical devices, and blood and blood components. The Act regulates the supply, advertising, and evaluation of therapeutic goods within Australia, ensuring that such goods are safe, of high quality, and effective. It applies to persons and entities involved in the manufacture, importation, supply, and advertising of therapeutic goods, as well as to the conduct and transactions related to these activities. The Act has a national reach across the Commonwealth of Australia, and its provisions are enforced by the Therapeutic Goods Administration, a department under the Commonwealth's Department of Health. While the Act broadly covers therapeutic goods, certain exclusions and exemptions apply, such as for goods used for personal or domestic purposes. The Act also allows for the creation of subordinate instruments, which can extend or restrict the application of the Act’s provisions to specific circumstances or categories of goods. The recent consent granted under sections 14 and 14A of the Act to the Australian Red Cross Blood Service regarding the supply of blood and blood components from donors aged over 60 years without medical review, is an example of how the Act can be adapted to specific situations through subordinate instruments.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provides the framework for the Therapeutic Goods Administration (TGA) to grant consents that allow deviations from established standards for the supply of therapeutic goods. In this instance, section 14(1) of the Act allows a delegate of the Secretary of the Department of Health to consent to the supply of blood and blood components that do not conform with specified standards. The TGA, through its delegate, has exercised this power in response to an application by the Australian Red Cross Blood Service, permitting the collection of blood from donors older than the previously mandated age limits without requiring medical review (section 14A). Under the conditions set by the Act, the consent granted allows for the collection of blood and blood components from donors who are over 60 years of age and under 81 years of age, thereby bypassing the age limits set by the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components. This consent acknowledges that there is no evidence to support the exclusion of older donors and that the selection of blood donors is based on a skilled in-person interview, which negates the necessity for an annual medical review. The consent is specifically designed to be temporary, effective from 28 July 2015 until 28 July 2020, providing a clear timeframe within which these provisions will apply. The obligations imposed by this consent are primarily on the Australian Red Cross Blood Service and any other entities involved in the collection and supply of blood and blood components. These entities must ensure that the donors are within the specified age range and that the collection processes adhere to the conditions set by the TGA. Additionally, they must maintain records and processes that demonstrate compliance with these conditions. Failure to comply with the terms of the consent could result in legal and regulatory consequences, as the Act provides for both civil and criminal penalties for breaches of its provisions. In terms of potential breaches and the consequences thereof, the Therapeutic Goods Act 1989 includes provisions for offences and penalties. For example, section 32DA of the Act allows for fines and imprisonment for individuals and corporations found guilty of supplying therapeutic goods that do not comply with the Act or the conditions of any consent granted under it. The maximum penalties can be significant, with fines reaching up to $1.65 million for corporations and imprisonment terms that vary based on the severity and frequency of the offence. Civil penalties may also apply, further emphasising the importance of compliance with the Act and the conditions of the consent.