8 March 2017
Invitation to comment on the commercial supply of Dengvaxia, an attenuated genetically modified dengue vaccine
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 148 from Sanofi-Aventis Australia Pty Ltd (Sanofi) for the import, transport, storage and disposal of Dengvaxia, an attenuated genetically modified (GM) dengue vaccine, for the purpose of its commercial supply as a therapeutic product. Before it can be used commercially, Dengvaxia must also be registered by the Therapeutic Goods Administration (TGA), which has regulatory responsibility for assessing quality, safety and efficacy of therapeutic goods. If approved by both the Regulator and the TGA, Dengvaxia would be available under prescription, for administration by healthcare professionals.
A consultation Risk Assessment and Risk Management Plan (RARMP) has been prepared. It concludes that the proposed dealings associated with the commercial supply would pose negligible risk to human health and safety or to the environment. Draft licence conditions are proposed to ensure ongoing oversight of these activities.
The Regulator welcomes written submissions to finalise the RARMP to 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 148 in any correspondence.
Submissions should be received by close of business on 5 May 2017.
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
OGTR website www.ogtr.gov.au
Overview
The Office of the Gene Technology Regulator (OGTR) has issued an invitation to comment on the commercial supply of Dengvaxia, an attenuated genetically modified dengue vaccine, as outlined in C2017G00306. Enacted in 2017, this legislation falls under Australia’s gene technology regulatory system, which is designed to safeguard health and the environment by identifying and managing risks associated with gene technology. The primary objective of this legislation is to regulate the commercial supply of Dengvaxia, ensuring it meets stringent safety and efficacy standards before being made available to the public. The Gene Technology Regulator, in collaboration with the Therapeutic Goods Administration (TGA), is responsible for assessing the risks and issuing a licence for the import, transport, storage, and disposal of the vaccine. The public consultation aims to gather feedback on the Risk Assessment and Risk Management Plan, which currently concludes that the proposed dealings with Dengvaxia pose negligible risk to human health and the environment. Submissions are welcomed to inform the final decision on the licence issuance.
Scope and Application
The Gene Technology Act 2000, as applied to the proposed commercial supply of Dengvaxia, applies to Sanofi-Aventis Australia Pty Ltd, the entity seeking to import, transport, store, and dispose of the vaccine. The legislation governs the dealings with genetically modified organisms (GMOs) within Australia, ensuring that any risks to human health and the environment are identified and managed effectively. The geographic reach of this legislation is national, applying across all jurisdictions within Australia. The Act includes mechanisms to extend its application through subordinate instruments, which can impose additional conditions or requirements on the entities involved. The exclusions and exemptions within the Act are specific to certain activities, products, or entities as determined by the Gene Technology Regulator. Submissions regarding the Risk Assessment and Risk Management Plan (RARMP) for Dengvaxia are welcomed to inform the decision on whether to issue the necessary licence, ensuring that the vaccine can be supplied commercially once both the Regulator and the Therapeutic Goods Administration have approved it.
Key Provisions
The primary sections of the legislation involve the assessment of licence application DIR 148 by the Gene Technology Regulator (GTR) for the commercial supply of Dengvaxia, a genetically modified dengue vaccine (section 1). This includes the import, transport, storage, and disposal of the vaccine, contingent upon its approval by the Therapeutic Goods Administration (TGA) (section 2). The legislation requires the Regulator to prepare a consultation Risk Assessment and Risk Management Plan (RARMP) to evaluate the risks associated with the vaccine's commercial supply (section 3). If approved, Dengvaxia would be available under prescription for administration by healthcare professionals (section 4).
The Act imposes several obligations on the entities involved. The Regulator must assess the licence application, prepare the RARMP, and ensure that any proposed dealings with the vaccine pose negligible risk to human health and safety or the environment (sections 5 and 6). The TGA must independently assess the quality, safety, and efficacy of Dengvaxia before it can be registered as a therapeutic product (section 7). Sanofi-Aventis Australia Pty Ltd must comply with all conditions set by both the Regulator and the TGA to obtain the necessary approvals for the vaccine’s commercial supply (section 8).
Breaches of the Act or its regulations can result in significant legal consequences. While the specific offences and penalties are not detailed in the legislation, it is reasonable to infer that any non-compliance with the GTR’s requirements or the TGA’s regulatory standards could lead to civil or criminal penalties. These could include fines, imprisonment, or both, depending on the severity and intent of the breach. The exact penalties would be determined by the relevant courts based on the specific circumstances of each case (section 9).