Designation of Deutetrabenazine as an orphan drug by Teva Pharma Australia

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, was designed to regulate therapeutic goods in Australia, ensuring they are safe and of high quality. This legislation plays a crucial role in protecting public health by controlling the supply, advertising, and promotion of therapeutic goods, including medicines, medical devices, and blood products. The 1989 Act was introduced to address the need for a comprehensive regulatory framework that could effectively manage the diverse range of therapeutic goods available in the Australian market, thereby safeguarding consumers and supporting innovation in the health sector. This particular gazette, issued under the authority of the Therapeutic Goods Regulations 1990, designates Deutetrabenazine as an orphan drug for the treatment of chorea associated with Huntington's disease. This designation was made by Dr Anthony Gill, a Delegate of the Secretary, on 9 May 2016. The sponsor of Deutetrabenazine is Teva Pharma Australia Pty Ltd. The policy objective behind this designation is to encourage the research and development of treatments for rare diseases by providing incentives such as orphan drug status, which can include streamlined regulatory processes and potential market exclusivity.

Scope and Application

The Therapeutic Goods Act 1989, as amended, is a piece of Australian legislation that applies to the regulation of therapeutic goods within Australia. This Act provides a comprehensive framework for the regulation of therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and genetically modified organisms. The Act applies to the conduct and transactions involving therapeutic goods, encompassing both the supply and advertising of such goods. It applies nationally, extending across all states and territories of Australia, thus establishing a uniform set of standards and regulatory practices across the Commonwealth. The Act's application is managed by the Therapeutic Goods Administration (TGA), an agency of the Australian Government's Department of Health, which oversees the regulation of therapeutic goods to ensure they meet quality, safety, and efficacy standards. The scope of the Act is further extended and defined through subordinate legislation, such as the Therapeutic Goods Regulations 1990, which provide detailed provisions on the registration, advertising, and other aspects of therapeutic goods. The Act also includes specific exclusions and exemptions, such as for therapeutic goods used for personal, non-commercial purposes or for goods that fall under other specific legislative frameworks.

Key Provisions

The primary operative section of the legislation, subregulation 16J(2) of the Therapeutic Goods Regulations 1990, designates Deutetrabenazine as an orphan drug for the treatment of chorea associated with Huntington's disease. This designation was made on 9 May 2016 by Dr Anthony Gill, who is acting as the Delegate of the Secretary under section 16J of the Regulations. Deutetrabenazine is specified to be in the form of film-coated tablets for this particular medical use. The legislation imposes certain obligations on the parties involved. Specifically, it requires the sponsor of Deutetrabenazine, which is Teva Pharma Australia Pty Ltd, to ensure that the drug is manufactured, packaged, and labelled in accordance with the standards set out in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. The designation of Deutetrabenazine as an orphan drug also likely entails obligations related to the provision of data and information to support the therapeutic use of the drug, as well as compliance with any conditions or restrictions imposed by the Therapeutic Goods Administration (TGA). Under the Therapeutic Goods Act 1989, breaches of the Act or Regulations can result in both civil and criminal penalties. Civil penalties can include fines, with the maximum penalty varying depending on the specific offence and the seriousness of the breach. For instance, knowingly or recklessly making a false or misleading representation in relation to a therapeutic good can attract a fine of up to $222,200 for an individual or $1,111,100 for a body corporate. Criminal penalties can also apply, with offences such as supplying a therapeutic good that does not comply with the Act or Regulations potentially resulting in imprisonment for up to five years or a fine, or both, depending on the severity of the offence. In summary, the legislation designates Deutetrabenazine as an orphan drug for treating chorea associated with Huntington's disease, imposes obligations on the sponsor to ensure compliance with manufacturing and labelling standards, and outlines potential civil and criminal penalties for breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.