Consent given pursuant to Sections 14 and 14A for the supply of the therapeutic goods specified by Aspen Pharma Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to establish a national system for regulating therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This Act was introduced to address the need for a cohesive regulatory framework that would streamline the approval, registration, and monitoring of therapeutic goods across Australia. The Act empowers the Therapeutic Goods Administration, under the Department of Health, to implement and enforce regulations that safeguard public health by controlling the supply and marketing of therapeutic goods. The policy objective behind the Act is to ensure that therapeutic goods available in Australia meet necessary standards of quality, safety, and efficacy, thus protecting consumers from potentially harmful products. In the specific case of the notice issued on 12 June 2015, the Act facilitated the granting of consent for certain cold sore creams to be supplied despite not meeting all microbiological standards, contingent upon meeting specific antimicrobial effectiveness criteria.

Scope and Application

The Therapeutic Goods Act 1989, as amended, applies to therapeutic goods supplied within Australia, regulating their quality, safety, efficacy, and public health risks. The Act governs the approval, registration, and monitoring of therapeutic goods, which encompass medicines, medical devices, blood and blood components, and tissues. This legislation applies to all entities involved in the supply chain of therapeutic goods, including manufacturers, importers, sponsors, and distributors, as well as to individuals such as healthcare professionals who prescribe or supply these goods. The Act’s jurisdiction is nationwide, covering the Commonwealth, states, and territories of Australia. Notably, the Therapeutic Goods Act 1989 may have exclusions or exemptions, often detailed in subordinate instruments such as regulations and orders, which specify particular classes of goods or circumstances where the Act’s requirements may be modified or waived. The application of the Act can also be extended or restricted through these subordinate instruments, thereby offering flexibility in its enforcement and scope.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 allow the Secretary of the Department of Health to grant consent for certain therapeutic goods that do not conform to specific standards to be supplied, provided that certain conditions are met. In this instance, the Secretary has granted consent for three cold sore creams—CHEMISTS’ OWN cold sore cream, AMCAL cold sore cream, and GUARDIAN cold sore cream—to be supplied despite their non-compliance with the microbiological standards set out in section 8 of the Therapeutic Goods Order No. 77. This consent is in response to an application made by Aspen Pharma Pty Ltd and is effective until 30 November 2016. The consent granted under section 14A of the Act is subject to specific conditions, which are outlined under subsection 15(1) of the Act. In this case, the primary condition is that the cold sore creams must meet the acceptance criteria for Aspergillus brasiliensis as specified in the USP General Chapter <51> Antimicrobial Effectiveness Testing. This condition aims to ensure that the products supplied still meet certain safety and efficacy standards, despite not complying with the microbiological standards set out in the Therapeutic Goods Order No. 77. The Therapeutic Goods Act 1989 imposes certain obligations on the parties involved in the supply of therapeutic goods. For the supplier, Aspen Pharma Pty Ltd, this includes ensuring that the cold sore creams meet the specified conditions for consent, such as meeting the acceptance criteria for Aspergillus brasiliensis. Additionally, the supplier must comply with any other requirements or conditions imposed by the Secretary under the Act. For the consumers, the Act ensures that the therapeutic goods supplied are of acceptable quality and meet certain safety standards, subject to the consent granted by the Secretary. Failure to comply with the conditions of the consent granted under the Therapeutic Goods Act 1989 may result in various civil or criminal consequences. Under the Act, breaches of the conditions may be considered an offence, and penalties can be imposed. The maximum penalties for breaches of the Act can include fines and imprisonment, depending on the nature and severity of the offence. Additionally, civil consequences may arise if consumers are harmed by non-compliant therapeutic goods, leading to potential legal action against the supplier.