Overview

The Gene Technology Act 2000, enacted by the Parliament of Australia, aims to establish a regulatory framework for the assessment and management of risks associated with gene technology. This Act was introduced to address the need for a comprehensive system to ensure the protection of public health and the environment while facilitating the development and use of genetically modified organisms. The Act empowers the Gene Technology Regulator to oversee the regulation of gene technology activities, including the assessment of applications for the commercial supply of genetically modified products such as Vaxchora®, a genetically modified cholera vaccine under consideration by the Regulator. The policy objective of the Act is to ensure that gene technology is used in a manner that minimises potential risks, thereby safeguarding health and environmental integrity. In this context, the Regulator is currently evaluating a licence application from Biocelect Pty Ltd for the commercial supply of Vaxchora®, pending approval from both the Gene Technology Regulator and the Therapeutic Goods Administration. The public is invited to submit comments on the Risk Assessment and Risk Management Plan (RARMP) prepared by the Regulator, which concludes that the proposed release of the vaccine poses negligible risk. Submissions are welcomed to assist in finalising the RARMP, with a deadline of 17 November 2020.

Scope and Application

The proposed legislation outlined in Gazette C2020G00769 concerns the regulation of gene technology in Australia, specifically focusing on the commercial supply of a genetically modified cholera vaccine, Vaxchora®, by Biocelect Pty Ltd. This Act applies to the entities and individuals involved in the commercial supply of this genetically modified vaccine, ensuring that all potential risks to human health and the environment are thoroughly assessed and managed. The application for this legislation extends across the Commonwealth, implying that it holds jurisdiction nationwide and is overseen by the Gene Technology Regulator. This Regulator, in conjunction with the Therapeutic Goods Administration (TGA), is tasked with the dual responsibility of evaluating the vaccine’s safety and efficacy before it can be made available for commercial use. The Act does not specify any exclusions or exemptions, but it does propose draft licence conditions to ensure ongoing oversight and compliance with the regulatory standards. The Regulator encourages public submissions to finalise the Risk Assessment and Risk Management Plan, indicating a commitment to transparency and community involvement in the regulatory process.

Key Provisions

The legislation in question, C2020G00769, concerns the proposed commercial supply of a genetically modified (GM) cholera vaccine, Vaxchora®, in Australia. This is a significant step in the country’s gene technology regulatory framework aimed at safeguarding health and the environment by managing risks associated with gene technology. The primary operative section involved in this regulation is section 62(1) of the Gene Technology Act 2000, which mandates that the Gene Technology Regulator must assess any application for a licence to conduct a controlled act involving genetically modified organisms. In this case, the Regulator is evaluating application DIR 174 from Biocelect Pty Ltd for the commercial supply of Vaxchora®, a vaccine designed for individuals aged two years and older who are travelling to areas with a risk of cholera infection. The Act imposes several obligations on Biocelect Pty Ltd and other parties involved. Firstly, Biocelect must submit a comprehensive Risk Assessment and Risk Management Plan (RARMP) to the Regulator, as outlined in section 63 of the Act. This document must detail the potential risks associated with the release of the GM cholera vaccine and the measures proposed to mitigate these risks. The Regulator has already prepared a draft RARMP for Vaxchora®, which concludes that the proposed release poses negligible risk to human health and the environment. Secondly, the Therapeutic Goods Administration (TGA) must also assess and register the vaccine, ensuring it meets quality, safety, and efficacy standards as per the Therapeutic Goods Act 1989. If approved by both the Regulator and the TGA, Vaxchora® would be available under prescription for oral administration. Failure to comply with the provisions of the Act can lead to significant legal consequences. Under section 103 of the Gene Technology Act 2000, any person who contravenes the Act or its regulations may be subject to enforcement actions. The Act stipulates various penalties, including substantial fines for individuals and corporations. For example, section 118 of the Act allows for penalties of up to $1.2 million for companies and up to $222,000 for individuals, depending on the severity of the breach. Additionally, the Regulator has the authority to seek injunctions and other remedies to prevent or rectify non-compliance. These penalties are designed to ensure that the stringent regulatory standards are upheld to protect public health and the environment.