Publication of List of Manufacturers Revoked from Licensing for the Manufacture of Therapeutic Goods – 8 March 2023

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This Act empowers the Therapeutic Goods Administration (TGA), which operates under the Department of Health and Aged Care, to oversee the manufacturing, importing, advertising, and distribution of therapeutic goods. The 1989 Act was introduced to address the need for a comprehensive regulatory framework that could protect public health by ensuring that therapeutic goods available in Australia meet safety, quality, and performance standards. The policy objective underpinning this legislation is to safeguard consumers by maintaining rigorous standards for the therapeutic goods market. On 8 March 2023, Katherine Clark, acting as the Delegate of the Secretary of the Department of Health and Aged Care, published a notice under Section 41(1)(d) of the Therapeutic Goods Act 1989, announcing the revocation of manufacturing licences for certain therapeutic goods. This action was taken at the request of the manufacturers involved, including PureIV, Australian Red Cross Lifeblood, and Pfizer Australia Pty Ltd. The revocations reflect the manufacturers' decisions to cease operations or to voluntarily relinquish their licences, thereby ensuring that the TGA can maintain stringent oversight of the therapeutic goods supply chain in Australia.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of entities and individuals involved in the manufacture, supply, and advertising of therapeutic goods in Australia. This includes companies, organisations, and individuals who are involved in any aspect of the lifecycle of therapeutic goods, from research and development through to sale and distribution. The Act's reach extends across the Commonwealth, ensuring a uniform standard for the safety, quality, and efficacy of therapeutic goods nationwide. However, certain entities such as those involved in the supply of therapeutic goods for personal use or for export only may be exempt from some of the Act's requirements. Additionally, the application of the Act can be influenced by subordinate instruments, which may introduce further regulations or exemptions tailored to specific circumstances or types of therapeutic goods. The revocation of a manufacturer's licence, as seen in the gazetted notice, is an example of the Act's enforcement mechanisms, which are designed to maintain high standards of therapeutic goods safety and quality within Australia.

Key Provisions

The Therapeutic Goods Act 1989 includes provisions that allow the Secretary to revoke a manufacturer's licence for the production of therapeutic goods under Section 41(1)(d) (1). This section empowers the Secretary to issue a written notice revoking a licence at the request of the manufacturer, which is precisely what has occurred in this case with PureIV (MI-2019-LI-02208-1), Australian Red Cross Lifeblood (MI-2017-LI-06919-1), and Pfizer Australia Pty Ltd (MI-2014-LI-00757-1). The revocation takes effect immediately upon the publication of the notice in the Commonwealth Gazette. Entities holding a licence to manufacture therapeutic goods under the Therapeutic Goods Act 1989 have several obligations and responsibilities. They must ensure compliance with all regulatory requirements, including maintaining proper manufacturing practices, conducting regular quality checks, and reporting any adverse events related to the therapeutic goods they produce. These entities must also keep detailed records of their manufacturing processes and be prepared to provide these records to the Therapeutic Goods Administration upon request. Furthermore, they must respond promptly to any notices or directives issued by the Therapeutic Goods Administration. Breaching the obligations and requirements outlined in the Therapeutic Goods Act 1989 can lead to various consequences, including civil and criminal penalties. The Act provides for substantial fines and, in some cases, imprisonment. For instance, under Section 28 of the Act, an individual who contravenes the provisions of the Act can be subject to a fine of up to $222,222 for a corporation or $44,444 for an individual, or imprisonment for up to two years, or both. These penalties underscore the seriousness with which the Act regards non-compliance and the importance of adhering to the stipulated manufacturing standards and regulatory requirements.