Invitation to comment on a clinical trial of genetically modified Lactobacillus brevis bacteria

Overview

The Gene Technology Act 2000, enacted by the Australian Parliament, was established to regulate the use, handling, and release of genetically modified organisms (GMOs) to ensure they do not adversely affect human health or the environment. The Act aimed to address the gap in regulatory frameworks surrounding the safe and responsible use of GMOs, particularly in clinical settings. The Gene Technology Regulator, under the auspices of the Office of the Gene Technology Regulator, oversees compliance with the Act and assesses applications for clinical trials involving genetically modified organisms, ensuring that robust risk assessments are conducted and managed. The policy objective of the Act is to balance the potential benefits of GMOs with stringent safety and environmental protection measures. On 24 July 2023, the Office of the Gene Technology Regulator issued a public notice regarding an application by Novotech (Australia) Pty Ltd to conduct a clinical trial involving genetically modified Lactobacillus brevis bacteria for the treatment of inflammatory bowel disease. The proposed trial would involve up to 60 participants over seven years, taking place at medical facilities and participants' homes. To facilitate informed decision-making, the Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) and invites written submissions focusing on human health and environmental protection. Submissions should reference DIR 197 and be submitted by 25 August 2023. Further information and the RARMP can be accessed via the Regulator's website or by contacting the specified office.

Scope and Application

The Gene Technology Act 2000, as applied in this clinical trial context, governs the assessment and regulation of genetically modified organisms, including the proposed clinical trial of genetically modified Lactobacillus brevis bacteria by Novotech (Australia) Pty Ltd for the treatment of inflammatory bowel disease. This Act applies to the entities conducting the trial, the genetically modified organism involved, and the associated conduct and transactions related to the trial. The geographic scope of the Act is national, applying across Australia, as the Gene Technology Regulator is a Commonwealth authority. The Act mandates that the Regulator prepare a Risk Assessment and Risk Management Plan (RARMP) to evaluate the potential risks to human health and the environment, and this requirement is evident in the current application process. The consultation period invites public submissions to contribute to the risk assessment and decision-making process. The Act's application is not limited to specific industries but rather encompasses any entity proposing activities involving genetically modified organisms. The Act does not explicitly state exclusions or exemptions, but the specific conditions and thresholds for the application of the Act are detailed in the RARMP and other subordinate instruments that the Regulator may use to extend or restrict the application of the Act in particular circumstances.

Key Provisions

The main operative sections of the legislation pertain to the assessment and approval of a clinical trial for genetically modified Lactobacillus brevis bacteria. Section 31 of the legislation details the application process, which requires the Gene Technology Regulator to evaluate an application from Novotech (Australia) Pty Ltd for a clinical trial to treat inflammatory bowel disease. The application involves treating up to 60 participants over seven years in medical facilities and at the participants' homes. Section 32 outlines the necessity for the Regulator to prepare a Risk Assessment and Risk Management Plan (RARMP) to evaluate the potential risks to human health and safety and the environment. The Regulator invites written submissions on the RARMP to aid in making an informed decision on whether to grant the licence for the clinical trial. The obligations imposed by the Act on the parties involved include ensuring that all submissions related to the RARMP reference DIR 197 and are received by the specified deadline, 25 August 2023. Section 33 mandates that the submissions focus on the protection of human health and safety and the environment. Novotech (Australia) Pty Ltd must also ensure that the clinical trial adheres to the conditions outlined in the RARMP once a licence is granted. The Regulator, in turn, is required to review the submissions and RARMP thoroughly, considering the potential impacts on health and the environment before making a decision. Should there be a breach of the provisions outlined in the legislation, various consequences may apply. Section 35 details the potential offences and penalties. For instance, if Novotech (Australia) Pty Ltd fails to comply with the terms of the licence or the RARMP, it may face civil or criminal penalties. The maximum penalties for breaches can include substantial fines and, in some cases, imprisonment. The specific penalties are determined based on the severity and nature of the breach, with the aim of enforcing compliance and protecting public health and the environment.