Invitation to Comment on Genetically Modified Cholera Vaccine Clinical Trial

Overview

The Office of the Gene Technology Regulator (OGTR) has issued a public notice for submissions on Licence Application DIR 126, which is PaxVax Australia Pty Ltd's application to conduct a clinical trial of a genetically modified cholera vaccine in Australia. This trial, which was enacted under the Gene Technology Act 2000, aims to address the need for a safe and effective vaccine against cholera by using gene technology. The application is currently under review by the Gene Technology Regulator, who is tasked with ensuring that the trial poses negligible risk to human health and the environment. The Regulator has prepared a consultation Risk Assessment and Risk Management Plan (RARMP) and draft licence conditions to guide the clinical trial. Public submissions are welcomed and will be considered in finalising the RARMP, which will then inform the decision on whether to issue the licence for the trial. Submissions should be submitted by close of business on 6 March 2014, with related documents and the consultation RARMP available on the OGTR website or by contacting the Office.

Scope and Application

The Gene Technology Act 2000, as it applies to Licence Application DIR 126 from PaxVax Australia Pty Ltd, governs the assessment and regulation of the proposed clinical trial of a genetically modified cholera vaccine in Australia. The Act applies to the entities involved in the trial, specifically PaxVax Australia Pty Ltd, and encompasses the clinical trial activities conducted in Queensland, South Australia, Victoria, and Western Australia. The legislation aims to ensure that any risks associated with gene technology are effectively identified and managed to protect human health and the environment. The application of the Act is national, as it falls under the Commonwealth’s jurisdiction. The Act includes mechanisms for public consultation, as evidenced by the current invitation for submissions on the Risk Assessment and Risk Management Plan (RARMP) for this clinical trial. Any exclusions or exemptions from the application of the Act are not specified in the text, though the assessment process itself incorporates a detailed evaluation of potential risks and conditions to mitigate them. The Act also facilitates the imposition of specific licence conditions through subordinate instruments, which would govern the conduct and limitations of the clinical trial if the licence is granted.

Key Provisions

The main operative sections of the Gazette C2014G00134 invite comment on Licence Application DIR 126, which PaxVax Australia Pty Ltd has submitted for a clinical trial of a genetically modified cholera vaccine. The application, under section 34(1) of the Gene Technology Act 2000, seeks to verify the effectiveness of the vaccine through a trial involving up to 1000 volunteer adults and children across Queensland, South Australia, Victoria and Western Australia. The application includes a Risk Assessment and Risk Management Plan (RARMP), which, according to section 34(3), must outline the risks posed by the trial to human health, safety and the environment, as well as measures to mitigate these risks. The Office of the Gene Technology Regulator (OGTR) is responsible for assessing this application, and section 40(1) empowers the Regulator to either approve or reject the application based on the RARMP and other relevant considerations. The obligations and requirements imposed by the Gene Technology Act 2000 on the parties involved are comprehensive. PaxVax Australia Pty Ltd must submit a detailed RARMP, which must be considered by the Regulator. The RARMP must provide a thorough assessment of the risks associated with the clinical trial, including any potential impacts on human health and the environment. It must also outline measures to mitigate these risks, ensuring that the trial is conducted safely and responsibly. The Regulator, on the other hand, must review the application and RARMP, consider any public submissions received under section 46(1), and make a decision on whether to grant the licence under section 40(1). This decision must be based on a careful evaluation of the potential risks and benefits of the trial. There are potential consequences for non-compliance with the provisions of the Gene Technology Act 2000. Under section 80(1), any person who contravenes the Act or a licence condition may be subject to a range of penalties. These can include fines and imprisonment, with the maximum penalty varying depending on the specific offence. For example, under section 80(2)(a), a person who intentionally or recklessly contravenes a licence condition may be subject to a fine of up to $1,110,000 for a corporation, or $222,000 for an individual, or imprisonment for up to five years, or both. The Act also provides for civil remedies, such as injunctions and damages, under section 81, to address any harm caused by non-compliance. These provisions ensure that the regulatory framework is enforced effectively, protecting public health and the environment from the risks associated with gene technology.