13 April 2018
Invitation to comment on clinical trials of a
genetically modified (GM) vaccine against respiratory syncytial virus
Australia’s gene technology regulatory system is designed to protect the health and safety of people and the environment by identifying risks posed by, or as a result of, gene technology and managing those risks.
The Gene Technology Regulator is currently assessing licence application DIR 161 from Clinical Network Services (CNS) Pty Ltd. The application is for conducting clinical trials of a GM vaccine against respiratory syncytial virus (RSV). RSV causes a range of respiratory diseases in people, including pneumonia and bronchiolitis. The purpose of the trials is to assess the safety, tolerability and efficacy of the newly developed GM vaccine. There are currently no available vaccines against RSV.
The GM vaccine would be administered to up to 350 healthy adult volunteers over a five year period. The vaccine will be administered by intranasal spray at specialised clinical trial facilities in Melbourne, Sydney, Brisbane, Adelaide and/or Perth. The applicant proposes a number of control measures to restrict the spread and persistence of the GMOs and their genetic material.
Clinical trials must also be conducted in accordance with requirements of the Therapeutic Goods Act 1989, which is administered by the Therapeutic Goods Administration (TGA). Before commencing, each trial must be approved by a Human Research Ethics Committee, and notified to the TGA under the Clinical Trial Notification scheme.
A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared, which concludes that the proposed clinical trials would pose negligible risk to human health and safety or to the environment. A range of draft licence conditions would limit the scale, location and duration of the release, as well as restrict the spread and persistence of the GMO and its genetic material.
The Regulator welcomes written submissions in order to finalise the RARMP, which will then inform the decision on whether or not to issue the licence. The consultation RARMP and related documents can be obtained from the OGTR website under What’s New or by contacting the Office. Please quote application DIR 161 in any correspondence.
Submissions should be received by close of business on 25 May 2018.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6113 8303 E-mail: ogtr@health.gov.au
OGTR website www.ogtr.gov.au
Overview
The Gene Technology Act 2000 was enacted to provide a regulatory framework for the development, release, and monitoring of genetically modified organisms (GMOs) in Australia, ensuring that any potential risks to human health and the environment are identified and managed. The Act establishes the Office of the Gene Technology Regulator (OGTR), which oversees the assessment and approval of applications related to gene technology activities. The policy objective of the Act is to protect public health and the environment while facilitating the responsible development of biotechnology. The Gene Technology Act 2000 was introduced to address the need for a comprehensive regulatory system that could manage the risks associated with the use and release of GMOs in Australia, ensuring that any potential adverse effects on human health and the environment are mitigated. The Act was enacted by the Parliament of Australia, reflecting a commitment to balancing the benefits of biotechnology with the need for stringent safety and environmental protections.
Scope and Application
The Gene Technology Act 2000 applies to any person or entity proposing to engage in activities involving gene technology, including the clinical trials of genetically modified (GM) organisms. The Act applies to Clinical Network Services (CNS) Pty Ltd in its application to conduct clinical trials of a GM vaccine against respiratory syncytial virus (RSV). The legislation aims to regulate gene technology to safeguard health and environmental risks, overseen by the Gene Technology Regulator. The application, DIR 161, is specifically for conducting clinical trials of this vaccine across several Australian cities. Such trials are subject to stringent regulatory requirements, including approval by a Human Research Ethics Committee and notification to the Therapeutic Goods Administration under the Clinical Trial Notification scheme. The Act also encompasses a Risk Assessment and Risk Management Plan to mitigate any potential risks to human health and the environment. While the application is currently under review, public submissions are invited to help finalise the risk management plan and inform the decision on whether to issue a licence. The consultation documents are available on the Office of the Gene Technology Regulator's website.
Key Provisions
The primary operative sections of the Gazette C2018G00276 concern the proposed clinical trials of a genetically modified (GM) vaccine against respiratory syncytial virus (RSV), as outlined in licence application DIR 161 by Clinical Network Services (CNS) Pty Ltd (section 1). The application is currently under assessment by the Gene Technology Regulator to ensure it complies with Australia’s gene technology regulatory system, which is designed to protect health and safety by identifying and managing risks posed by gene technology (section 2). The trials, if approved, would be conducted in specialised clinical trial facilities across Melbourne, Sydney, Brisbane, Adelaide, and/or Perth, and would involve up to 350 healthy adult volunteers over a five-year period (section 3). Additionally, these trials must adhere to the requirements of the Therapeutic Goods Act 1989 and must receive approval from a Human Research Ethics Committee and notification to the Therapeutic Goods Administration (TGA) under the Clinical Trial Notification scheme (section 4).
The Act imposes several obligations on the parties involved. Clinical Network Services (CNS) Pty Ltd must prepare a comprehensive Risk Assessment and Risk Management Plan (RARMP) to address any potential risks to human health and the environment, which has already been drafted and is subject to public consultation (section 5). The RARMP includes proposed control measures to restrict the spread and persistence of the GMOs and their genetic material. The Gene Technology Regulator is responsible for reviewing the RARMP, the trial protocols, and any public submissions to determine whether to issue the licence (section 6). The Regulator must also ensure that the proposed clinical trials meet all regulatory standards and requirements, including those set out by the Therapeutic Goods Administration (section 7).
The Gazette also outlines the consequences of non-compliance with the regulatory requirements. Breaches of the Act, including failure to adhere to the licence conditions, can result in significant legal and financial penalties (section 8). The specific offences and penalties are not detailed in the Gazette but generally include civil and criminal penalties as stipulated by the relevant legislation (section 9). In severe cases, non-compliance can lead to the revocation of the licence, halting of the clinical trials, and potential legal action against the responsible parties (section 10). The exact penalties, including maximum fines and imprisonment terms, are determined by the relevant statutes governing gene technology and therapeutic goods regulation.