Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Ego Pharmaceuticals

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, was introduced to regulate therapeutic goods in Australia, including medicines, medical devices, and blood. It aims to protect public health by ensuring that these goods are of acceptable quality, safe, and effective. The Act was established to address the need for a comprehensive regulatory framework that ensures the safety and quality of therapeutic goods available to the Australian public. This legislative act allows for the control of therapeutic goods throughout their lifecycle, from research and development through to post-market surveillance. The Act provides the Therapeutic Goods Administration (TGA) with the authority to regulate these goods to ensure they meet required standards and are appropriately advertised and labelled. On 18 November 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to Ego Pharmaceuticals Pty Ltd for the supply of Pinetarsol Gel, a tar-based medication, despite it not meeting certain preservative efficacy standards. The consent, which is effective until 18 November 2017, is conditional upon the product meeting antimicrobial efficacy requirements as specified in the United States Pharmacopoeia - National Formulary. This consent demonstrates the TGA’s role in balancing public health protection with the need to make therapeutic goods available, particularly when there are no suitable alternatives.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, including medicines, medical devices, blood, and tissues. This Act applies to entities such as manufacturers, importers, sponsors, and suppliers of therapeutic goods, as well as to individuals who may be involved in the supply or distribution of these goods. The Act's jurisdictional reach is national, covering all therapeutic goods intended for use in Australia, irrespective of the state or territory in which they are located. The Act includes provisions for exemptions and exclusions, which may apply to certain types of therapeutic goods or specific circumstances. Additionally, the application of the Act can be extended or restricted through subordinate instruments, such as therapeutic goods orders and regulations. In this particular case, the Therapeutic Goods Administration has granted a consent under sections 14 and 14A of the Act to Ego Pharmaceuticals Pty Ltd for the supply of Pinetarsol Gel, a medicine that does not conform to certain microbiological standards. This consent is subject to specific conditions, including a requirement for the medicine to meet antimicrobial efficacy standards as specified in the United States Pharmacopoeia.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 provide a mechanism for the Secretary of the Department of Health to grant consents for the supply of therapeutic goods that do not conform to certain standards set out in Therapeutic Goods Orders. Specifically, section 14 allows the Secretary to consent to the supply of such goods, while section 14A provides that any such consent is subject to conditions that the Secretary considers appropriate. In the case of Pinetarsol Gel, the Secretary granted consent under these sections for the supply of a product that does not meet the preservative efficacy requirements for A. niger specified in the British Pharmacopoeia and the European Pharmacopoeia, but is subject to the condition that the antimicrobial efficacy must meet the requirement specified in the United States Pharmacopoeia. The obligations imposed by the Therapeutic Goods Act 1989 on the parties or entities it governs are extensive. Manufacturers and suppliers of therapeutic goods must ensure that their products meet all relevant standards and comply with all applicable regulations. This includes obtaining any necessary consents from the Secretary of the Department of Health where a product does not conform to certain standards. Failure to comply with the Act and its associated regulations can result in serious consequences, including fines, imprisonment, and legal action. The Therapeutic Goods Act 1989 also imposes specific obligations on manufacturers and suppliers of therapeutic goods. These include ensuring that their products are safe and of high quality, obtaining and maintaining the necessary licenses and registrations, and keeping accurate records of all relevant information. In the case of Pinetarsol Gel, the manufacturer, Ego Pharmaceuticals Pty Ltd, must ensure that the product meets the antimicrobial efficacy requirement specified in the United States Pharmacopoeia and that all other relevant standards and regulations are complied with. Breach of the Therapeutic Goods Act 1989 can result in serious consequences, both civil and criminal. In some cases, individuals and companies can be fined up to $1.65 million, while individuals can also be imprisoned for up to 10 years. Additionally, the Act provides for the seizure and destruction of non-compliant products, and for legal action to be taken against those who breach its provisions. The consequences of non-compliance can be severe, and it is essential that manufacturers and suppliers of therapeutic goods take all necessary steps to ensure that their products meet all relevant standards and regulations.