19 August 2010
The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in response to a licence application (DIR 098) from Sanofi Pasteur Pty Ltd (Sanofi) for a commercial release of a genetically modified (GM) vaccine.
The Gene Technology Act 2000
(the Act), the Gene Technology Regulations 2001 and corresponding state and territory law govern the comprehensive and highly consultative process undertaken by the Regulator before making a decision whether to issue a licence to deal with a GMO. The decision is based upon a Risk Assessment and Risk Management Plan (RARMP) prepared by the Regulator in accordance with the requirements of the legislation. RARMP’s apply the Risk Analysis Framework
and are finalised following consultation with a wide range of experts, agencies and authorities, and the public. 1
The Regulator received an application from Sanofi for a licence for dealings involving the intentional release of a live genetically modified (GM) viral vaccine for the prevention of Japanese Encephalitis.
The GM vaccine is based on the existing vaccine for Yellow fever in which two genes have been replaced by similar genes from Japanese encephalitis virus
. It has been shown to protect vaccinated people against Japanese Encephalitis.
Sanofi proposed a commercial release of this vaccine in medical facilities throughout Australia. The vaccine is intended for people travelling to, or resident in, areas where the disease occurs and will be prescribed by registered medical practitioners and administered in medical facilities.
The risk assessment took into account information in the application (including proposed containment measures), relevant previous approvals, current scientific knowledge and advice received from a wide range of experts, agencies and authorities that were consulted on the preparation of the RARMP and the consultation RARMP. The risk context for this assessment considered the dealings import, transport and disposal associated with the commercial release. No new risks to people or the environment were identified from the advice received on the consultation RARMP.
Initially, risk identification was used to postulate potential pathways that might lead to harm to people or the environment as a result of gene technology (risk scenarios) and determine those that warrant detailed characterisation.
Five risk scenarios were identified. This included consideration of whether, or not, expression of the introduced genes could result in products that are toxic or allergenic to people or other organisms; alter characteristics that may impact on the disease burden due to the GM virus; or produce unintended changes in viral characteristics. Gene transfer to other organisms and its effects if this occurred was also assessed.
A risk is only identified when a risk scenario is considered to have some chance of causing harm. Pathways that do not lead to an adverse outcome, or could not reasonably occur, do not advance in the risk assessment process.
The characterisation of the five risk scenarios in relation to both the seriousness and likelihood of harm did not give rise to any identified risks that required further assessment.
Any risks of harm to the health and safety of people or the environment from the dealings associated with the proposed release, which are the import, transport and disposal of the GM vaccine, are assessed to be negligible
. Hence, the Regulator considers that the dealings involved in this commercial release do not pose a significant risk
to either people or the environment.
Risk management plan
Risk management is used to protect the health and safety of people and to protect the environment by controlling or mitigating risk. Risk management includes the preparation of a risk management plan to evaluate and treat identified risks, apply general risk management measures, and propose licence conditions.
As none of the five risk scenarios characterised in the risk assessment are considered to give rise to an identified risk that requires further assessment, the level of risk from the proposed dealings is assessed to be negligible
. The Regulator's Risk Analysis Framework
defines negligible risks as insubstantial, with no present need to invoke actions for their mitigation in the risk management plan. However, conditions have been imposed to allow appropriate oversight of the ongoing release.
The imposed licence conditions ensure that there is appropriate oversight of the ongoing release and require Sanofi to inform the Regulator of any amendments to the conditions of the TGA registration involving the pattern of use, handling, storage, transport or disposal of the GMO.
Conclusions of the consultation RARMP
The risk assessment concluded that the dealings associated with this commercial release of the GM vaccine as a prescription medicine pose negligible
risks to the health and safety of people or the environment as a result of gene technology.
The risk management plan concluded that these negligible
risks do not require specific risk treatment measures. However, licence conditions have been imposed to allow appropriate oversight of the ongoing release.
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