Overview

The Gene Technology Act 2000 was enacted by the Parliament of Australia to regulate the use of genetically modified organisms, including viruses, within the country. The Act aims to protect human health and the environment by ensuring that genetically modified organisms are handled and used responsibly. The Act addresses the gap in existing legislation by providing a comprehensive framework to manage the risks associated with the use of genetically modified organisms, ensuring that they do not pose any harm to people or the environment. The Office of the Gene Technology Regulator is responsible for assessing applications for clinical trials of genetically modified organisms and issuing licences accordingly. The policy objective of the Act is to balance the potential benefits of genetic technology with the need to protect human health and the environment. The Regulator is currently assessing an application from VRT Pharmaceutics Pty Ltd to conduct a clinical trial of a genetically modified Getah virus for cancer treatment, and is inviting written submissions on the proposed trial until 7 January 2022.

Scope and Application

The proposed legislation under C2021G00886, concerning the clinical trial of a genetically modified alphavirus for the treatment of cancer, applies specifically to VRT Pharmaceutics Pty Ltd, which is seeking to conduct this clinical trial in Australia. The Act involves the assessment of the risks associated with the trial, particularly those related to human health and safety and the environment, by the Gene Technology Regulator. The geographic reach of this legislation is national, as the trial is proposed to take place not only in Adelaide, South Australia, but also at other locations in Australia as required over a five-year period. The legislation is intended to ensure that up to 20 participants in the trial are adequately protected and that the environment is safeguarded against any potential adverse effects arising from the trial. The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) to guide this assessment and has invited written submissions from the public to inform the decision-making process. The legislation extends its application through subordinate instruments, including the RARMP, which provides detailed guidelines and requirements for managing the risks associated with the trial. Submissions in response to this invitation are due by 7 January 2022, and interested parties are encouraged to reference DIR 187 when submitting their feedback.

Key Provisions

The key provisions of the legislation, Gazetted as C2021G00886, relate to the proposed clinical trial of a genetically modified alphavirus for cancer treatment by VRT Pharmaceutics Pty Ltd. Section 1 details the application for the trial, including the specifics that the trial would involve a genetically modified Getah virus and would be conducted over a period of five years at a site in Adelaide, South Australia, and potentially other locations across Australia. The Office of the Gene Technology Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application (s.2), which is available for public comment and scrutiny. The obligations imposed by this legislation on the parties involved, primarily VRT Pharmaceutics Pty Ltd and the Gene Technology Regulator, include a requirement to adhere to the outlined protocols for the clinical trial and the submission of a comprehensive RARMP. This plan must address all potential risks to human health and the environment, ensuring that the trial is conducted in a manner that minimises any adverse effects (s.3). Furthermore, the Regulator must evaluate the RARMP and any public submissions before deciding whether to issue the necessary licence for the trial to proceed. In terms of potential breaches and the associated penalties, the legislation does not explicitly detail specific offences or penalties within the text provided. However, it is implied that any non-compliance with the outlined requirements or failure to adequately mitigate identified risks could result in the Regulator refusing to issue the licence for the trial. This refusal could, in turn, lead to legal and financial repercussions for the applicant, as well as potential delays or halts in the progress of the trial (s.4). Additionally, any harm caused to human health or the environment as a result of the trial could lead to further legal actions and penalties under other relevant Australian laws.