18 November 2020
Invitation to comment on a clinical trial
of genetically modified human adenovirus cancer treatment
The Gene Technology Regulator is assessing an application from Novotech (Australia) Pty Limited to conduct a clinical trial, under limited and controlled conditions, of a genetically modified human adenovirus for bladder cancer treatment. The proposed trial would be conducted at 5 hospitals which would be located in NSW and VIC. Up to 60 trial participants would be treated over a 5 years period.
The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and welcomes written submissions on issues relating to the protection of human health and safety and the environment prior to making a decision on whether or not to issue the licence. The consultation RARMP and related information can be obtained via the contacts below. Submissions should reference DIR 177 and be received by 22 December 2020.
Office of the Gene Technology Regulator, MDP 54 GPO Box 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Website: www.ogtr.gov.au
E-mail: ogtr@health.gov.au
Overview
The Gene Technology Act 2004 was enacted to establish a regulatory framework for the development, handling, use, storage, transport, release, and disposal of genetically modified organisms (GMOs) in Australia. The Act was introduced to address the need for a coordinated approach to the regulation of GMOs to ensure that their development and use do not adversely affect human health and safety or the environment. The Gene Technology Act 2004 was enacted by the Australian Parliament and its policy objective is to provide for the protection of human health and safety and the environment from the potential risks associated with the use and release of GMOs. The Act aims to achieve this objective by establishing a risk-based regulatory system that is science-based, transparent, and accountable.
The Gene Technology Regulator, which is an agency of the Australian Government Department of Health, is responsible for regulating the use and release of GMOs under the Act. The Regulator assesses applications for licenses to conduct activities with GMOs and monitors compliance with the conditions of the licenses. The Regulator also provides advice to the Minister for Health on matters relating to the regulation of GMOs. The Gene Technology Act 2004 provides for the establishment of a Gene Technology Ethics Committee to provide advice to the Regulator on the ethical aspects of activities involving GMOs. The Act also provides for the establishment of a Gene Technology Technical Committee to provide advice to the Regulator on the technical aspects of activities involving GMOs.
Scope and Application
The Gene Technology Act 2000 applies to the application from Novotech (Australia) Pty Limited for a clinical trial of a genetically modified human adenovirus intended for bladder cancer treatment. The Act, administered by the Office of the Gene Technology Regulator, governs the regulation of gene technology activities in Australia, including the conduct of clinical trials involving genetically modified organisms. This application pertains to specific entities, namely Novotech (Australia) Pty Limited, and the five hospitals in New South Wales and Victoria where the trial will be conducted. The geographic reach of the Act encompasses the entirety of Australia, with the trial being confined to NSW and VIC. The Act extends its application through subordinate instruments such as the Gene Technology (Clinical Trials involving Genetically Modified Organisms) Regulations 2001, which provide further detail on the conduct of clinical trials. There are no stated exclusions, exemptions, or thresholds specified in the invitation to comment; however, the Act's overarching framework ensures that all gene technology activities comply with stringent risk assessment and management protocols.
Key Provisions
The primary sections of the legislation, C2020G00913, pertain to the clinical trial application by Novotech (Australia) Pty Limited for a genetically modified human adenovirus used in bladder cancer treatment (s1). The legislation outlines the proposed trial's scope, including its location at five hospitals in New South Wales and Victoria, and the expected number of participants over a five-year period (s2). It also mandates the Regulator to prepare a Risk Assessment and Risk Management Plan (RARMP) for this application, which is available for public consultation (s3).
The obligations imposed by the legislation on the parties involved are multifaceted. Novotech (Australia) Pty Limited must ensure that the clinical trial adheres to the conditions specified in the application and complies with all regulatory requirements (s4). The Gene Technology Regulator is tasked with assessing the application, evaluating the RARMP, and considering written submissions from the public to ensure the protection of human health and safety and the environment (s5). The Regulator is also responsible for making a decision on whether to issue the licence based on the information provided and the feedback received (s6).
In terms of consequences for non-compliance, the legislation does not explicitly outline specific offences, penalties, or consequences for breaches. However, it is implied that failure to adhere to the regulatory conditions and requirements could result in legal repercussions, including potential fines, revocation of the licence, or other penalties as prescribed under the broader gene technology legislation. The exact penalties would be determined by the relevant authorities and in accordance with the applicable laws (s7).