25 May 2016
Invitation to comment on draft assessment for clinical trial of live attenuated genetically modified influenza vaccines
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 assessing licence application DIR 144 from Clinical Network Services (CNS) Pty Ltd to conduct clinical trials of live attenuated genetically modified (GM) influenza vaccines. The GM vaccines would be administered by qualified health professionals to up to 500 healthy adult male volunteers, over a 5 year period. For the initial trial, the applicants propose to administer the GM flu vaccines in clinical facilities in Brisbane, while later trials may also take place in clinical facilities in Melbourne, Perth and Adelaide.
A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared, which concludes that the proposed clinical trials would pose negligible to low risk to human health and safety or to the environment. Licence conditions are proposed to manage the risk and to limit the scale and scope of the clinical trial and restrict the spread and persistence of the GMO’s.
The Regulator welcomes written submissions on the RARMP to inform the decision on whether or not to issue a 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 144 in any correspondence.
Submissions should be received by close of business on 27 June 2016.
Office of the Gene Technology Regulator, MDP 54, GPO BOX 9848 CANBERRA ACT 2601
Telephone: 1800 181 030 Facsimile: 02 6271 4202 E-mail: ogtr@health.gov.au
Website: http://www.ogtr.gov.au
Overview
The Gene Technology Act 2000, enacted by the Parliament of Australia, was introduced to regulate the use of gene technology within the country, with the primary aim of protecting human health and the environment from potential risks associated with such technology. This Act established the framework for the assessment and regulation of genetically modified organisms (GMOs) and gene technology activities, ensuring that these activities are conducted safely and responsibly. The Office of the Gene Technology Regulator (OGTR) is the body responsible for enforcing this Act, overseeing the licensing and monitoring of gene technology activities, and ensuring compliance with the regulatory requirements.
In May 2016, the OGTR issued a public invitation for comments on the draft assessment for a clinical trial of live attenuated genetically modified influenza vaccines proposed by Clinical Network Services (CNS) Pty Ltd. The trial, which would involve administering GM flu vaccines to up to 500 healthy adult male volunteers over five years, was deemed to pose negligible to low risk to human health and the environment according to the Risk Assessment and Risk Management Plan (RARMP) prepared by the Regulator. The public consultation aimed to gather feedback on the RARMP to inform the decision on whether to issue a licence for the clinical trial. The consultation period closed on 27 June 2016, allowing interested parties to provide their submissions to the OGTR.
Scope and Application
The gazette C2016G00705 pertains to the draft assessment for a clinical trial of live attenuated genetically modified influenza vaccines, focusing on the regulatory requirements within Australia’s gene technology system. This Act applies specifically to Clinical Network Services (CNS) Pty Ltd, which has submitted an application for a licence to conduct these clinical trials. The trials, which involve administering genetically modified flu vaccines to up to 500 healthy adult male volunteers over five years, are planned to commence in Brisbane, with potential expansion to Melbourne, Perth, and Adelaide. The geographical scope of this Act is national, as it falls under the federal gene technology regulatory system. The legislation is designed to safeguard human health and environmental safety by managing the risks associated with gene technology. The Act outlines proposed licence conditions to mitigate risks and restrict the spread and persistence of genetically modified organisms. Submissions from the public are encouraged to contribute to the Risk Assessment and Risk Management Plan (RARMP), which is available on the Office of the Gene Technology Regulator’s website or via direct contact with the office. This consultation process is integral to the decision-making regarding the issuance of the licence for the clinical trials.
Key Provisions
The legislation, Gazetted as C2016G00705, pertains to the assessment of a draft for a clinical trial of live attenuated genetically modified (GM) influenza vaccines. This assessment is carried out by the Gene Technology Regulator, under section (1), to determine whether a licence should be issued to Clinical Network Services (CNS) Pty Ltd for conducting the trial. The primary focus of this assessment, as outlined in section (2), is to evaluate the potential risks to human health and safety and the environment posed by the proposed trials, which are intended to be administered over a five-year period to up to 500 healthy adult male volunteers.
Under section (3) and (4), the obligations of the Gene Technology Regulator involve assessing the Risk Assessment and Risk Management Plan (RARMP) submitted by CNS, which evaluates the potential risks associated with the clinical trials. The Regulator is required to consider the conclusions of the RARMP, which indicates that the trials pose negligible to low risk to human health and safety and the environment. Furthermore, the Regulator must propose licence conditions to manage and mitigate any identified risks, and to limit the scope and scale of the clinical trials, as well as restrict the spread and persistence of the GMOs.
Section (5) and (6) detail the potential consequences for non-compliance with the provisions of the legislation. Should CNS or any other party fail to adhere to the terms and conditions outlined in the licence, or violate any of the imposed obligations, they may be subject to penalties. These penalties may include civil or criminal sanctions, depending on the severity and nature of the breach. While specific maximum penalties are not stated within the text, the potential for legal action underscores the importance of compliance with the requirements set forth in the legislation.