Invitation to comment on draft assessment for the supply of
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 137 from AstraZeneca Pty Ltd for import, transport, storage and disposal of attenuated genetically modified (GM) influenza vaccines for the purpose of their commercial supply as therapeutic products. The Therapeutic Goods Administration has regulatory responsibility for assessing quality, safety and efficacy of vaccines, and is evaluating an application from AstraZeneca for the registration of the GM influenza vaccines. If approved by both the Regulator and the TGA, the GM influenza vaccines would be administered as a nasal spray by healthcare professionals at facilities where influenza vaccines are normally dispensed.
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 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 137 in any correspondence.
Submissions should be received by close of business on 13 November 2015.
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 was enacted to provide a regulatory framework that ensures gene technology activities are conducted in a manner that protects human health and safety and the environment. This Act was introduced to address the need for a robust system to manage the risks associated with gene technology, particularly those involving genetically modified organisms. The enacting body was the Australian Parliament, and the policy objective of the Act is to balance the benefits of gene technology with the need for stringent risk management. In the context of the proposed commercial supply of attenuated genetically modified influenza vaccines by AstraZeneca, the Act facilitates a coordinated assessment process between the Gene Technology Regulator and the Therapeutic Goods Administration, ensuring that both the environmental and health risks are adequately evaluated and managed.
Scope and Application
The Gene Technology Act 2000, as amended, provides the legislative framework for the regulation of gene technology in Australia, including the assessment of risks associated with genetically modified organisms. This includes the regulation of activities related to the import, transport, storage, and disposal of genetically modified products, such as the attenuated genetically modified influenza vaccines proposed by AstraZeneca Pty Ltd. The Act applies to entities such as companies and individuals involved in these activities, ensuring they comply with the requirements designed to safeguard public health and the environment. The Act has a national reach, overseen by the Gene Technology Regulator, which works in conjunction with the Therapeutic Goods Administration to ensure the quality, safety, and efficacy of therapeutic products. The Regulator’s assessment of licence application DIR 137 falls within this legislative framework, with specific conditions proposed to manage any potential risks associated with the commercial supply of these vaccines. Exclusions or exemptions from the Act’s application are limited and typically involve products that are subject to other specific regulatory regimes. The Act allows for the extension or restriction of its application through subordinate instruments, ensuring a flexible and responsive regulatory environment.
Key Provisions
The key provisions of the draft assessment for the supply of attenuated genetically modified influenza vaccines under the Gene Technology Act 2000 (Cth) include the assessment of the licence application DIR 137 by the Gene Technology Regulator (section 50). The Regulator is required to evaluate the risk assessment and risk management plan (RARMP) submitted by AstraZeneca Pty Ltd for the import, transport, storage, and disposal of the genetically modified (GM) influenza vaccines (section 50(1)). This involves assessing the potential risks to human health and the environment from these activities and determining whether the proposed measures are adequate to manage any identified risks (section 51).
The obligations under this legislation require AstraZeneca to provide a comprehensive RARMP that addresses potential risks and mitigation strategies (section 51(1)). This plan must be reviewed and approved by the Regulator, who must also ensure that any proposed dealings pose negligible risk to human health and the environment (section 51(2)). Additionally, the Therapeutic Goods Administration (TGA) must assess the quality, safety, and efficacy of the vaccines independently (section 32). Both the Regulator and TGA must collaborate to ensure that the vaccines meet all regulatory standards before approval for commercial supply (section 54).
Breach of the provisions under the Gene Technology Act 2000 may result in significant legal consequences. For instance, if a party fails to comply with the regulatory requirements, they may face civil penalties, including fines of up to $66,000 for individuals and $330,000 for corporations (section 118(1)). Criminal penalties can also apply, with maximum fines of up to $1.1 million for individuals and $5.5 million for corporations, along with potential imprisonment for up to five years (section 118(2)). Furthermore, the Regulator has the authority to impose additional conditions or revoke a licence if non-compliance is identified, ensuring ongoing oversight and management of risks associated with the supply of GM influenza vaccines (section 53).