Introduction
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Australian Academy of Science/Australian Academy of Technology and Engineering
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Finding 3:
The Academies support this finding.
Finding 4:
The Academies support this finding. While the Academies would expect synthetic biology applications to fall within the scope of the Gene Technology Scheme, the legislated definition of gene technology is unlikely to capture all aspects of the broader field of synthetic biology.
Finding 5:
The Academies support this finding. It is inappropriate for humans to be regulated under the Gene Technology Scheme. Government should consider the NHMRC Embryo Research Licensing Committee as an appropriate body to regulate research which involves human germline modification.
Nevertheless, there is no technical impediment to the application of gene technology to humans. For this reason, it is important for the Gene Technology Regulator to work closely with the regulatory body for human gene technology applications to ensure regulatory consistency and appropriate oversight.
Finding 6:
The Academies support this finding. Without wishing to pre-empt proper legal and administrative considerations, the Academies strongly favour an approach which is scientifically rigorous and well informed, which would include at a minimum an advisory capacity in environmental science and ecology on the GTTAC (as is currently the case).
It is imperative for the risks associated with environmental releases to be effectively identified and well managed, and it is vital for the legal frameworks to be set up in advance of any deployment and to be "technology ready". The Academies welcome future consultation on the regulation of broader environmental releases. As noted by the review, the envisaged releases differ from current Dealings involving Intentional Release (DIRs) in that they are not expected to be restricted to a particular field or farm. It is likely, therefore, for such releases to require significant engagement with local communities, a consideration which should be included in developing the necessary regulatory frameworks.
Finding 7:
The Academies suggest that regulatory measures for broad environmental releases (under Finding 6) should be established such that organisms modified to contain gene drives may be treated as a subset of broader environmental releases. Again, it is important that the legal and regulatory frameworks are set up in advance of the technology to provide certainty to researchers and confidence to other stakeholders.
The Academies support this finding.
Finding 4:
The Academies support this finding. While the Academies would expect synthetic biology applications to fall within the scope of the Gene Technology Scheme, the legislated definition of gene technology is unlikely to capture all aspects of the broader field of synthetic biology.
Finding 5:
The Academies support this finding. It is inappropriate for humans to be regulated under the Gene Technology Scheme. Government should consider the NHMRC Embryo Research Licensing Committee as an appropriate body to regulate research which involves human germline modification.
Nevertheless, there is no technical impediment to the application of gene technology to humans. For this reason, it is important for the Gene Technology Regulator to work closely with the regulatory body for human gene technology applications to ensure regulatory consistency and appropriate oversight.
Finding 6:
The Academies support this finding. Without wishing to pre-empt proper legal and administrative considerations, the Academies strongly favour an approach which is scientifically rigorous and well informed, which would include at a minimum an advisory capacity in environmental science and ecology on the GTTAC (as is currently the case).
It is imperative for the risks associated with environmental releases to be effectively identified and well managed, and it is vital for the legal frameworks to be set up in advance of any deployment and to be "technology ready". The Academies welcome future consultation on the regulation of broader environmental releases. As noted by the review, the envisaged releases differ from current Dealings involving Intentional Release (DIRs) in that they are not expected to be restricted to a particular field or farm. It is likely, therefore, for such releases to require significant engagement with local communities, a consideration which should be included in developing the necessary regulatory frameworks.
Finding 7:
The Academies suggest that regulatory measures for broad environmental releases (under Finding 6) should be established such that organisms modified to contain gene drives may be treated as a subset of broader environmental releases. Again, it is important that the legal and regulatory frameworks are set up in advance of the technology to provide certainty to researchers and confidence to other stakeholders.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Finding 8:
The Academies accept this finding, noting the opportunities for more targeted regulatory oversight identified in Finding 9, and the recognition that aspects of the Scheme may appropriately evolve towards a product-based trigger over time.
Finding 9:
The Academies support this finding, in particular the proposal to develop flexible mechanisms to move organisms between categories based on safe-use or new data. Over-regulation of low-risk gene modification technologies restricts research and technology development. Additionally, the Scheme must be able to adapt to newly identified risks.
Finding 10:
The Academies support streamlining and aligning the administrative processes of the regulatory system.
Finding 11:
The Academies support more effective use of the GMO Register along the lines proposed. The proposed changes will allow more efficient research conduct and improve the capacity of industry to diversify proven GM applications to commercial scale.
Finding 12:
The Academies support quantifying the scope of ‘DIY biology’ activity and initiatives to connect with this community. Irresponsible or unregulated use of GM technology carries at a minimum a risk of reducing community support. At the same time, the entry of SMEs into the biotech field should be encouraged and supported, and the regulatory environment should be equally manageable for smaller entities as for research organisations and large research-intensive companies.
Finding 13:
The Academies strongly support this finding. The proposed options would improve the flexibility of the Scheme and enable regulatory focus to be directed towards potentially higher risk applications.
Finding 14:
The Academies strongly support this finding, which would enhance the responsiveness of the governance process while maintaining national accountability for the operation of the Scheme.
Finding 15:
The Academies strongly support this finding. International harmonisation of regulatory regimes promotes the exchange of knowledge and technology resources and provides certainty to both researchers and industry.
The Academies accept this finding, noting the opportunities for more targeted regulatory oversight identified in Finding 9, and the recognition that aspects of the Scheme may appropriately evolve towards a product-based trigger over time.
Finding 9:
The Academies support this finding, in particular the proposal to develop flexible mechanisms to move organisms between categories based on safe-use or new data. Over-regulation of low-risk gene modification technologies restricts research and technology development. Additionally, the Scheme must be able to adapt to newly identified risks.
Finding 10:
The Academies support streamlining and aligning the administrative processes of the regulatory system.
Finding 11:
The Academies support more effective use of the GMO Register along the lines proposed. The proposed changes will allow more efficient research conduct and improve the capacity of industry to diversify proven GM applications to commercial scale.
Finding 12:
The Academies support quantifying the scope of ‘DIY biology’ activity and initiatives to connect with this community. Irresponsible or unregulated use of GM technology carries at a minimum a risk of reducing community support. At the same time, the entry of SMEs into the biotech field should be encouraged and supported, and the regulatory environment should be equally manageable for smaller entities as for research organisations and large research-intensive companies.
Finding 13:
The Academies strongly support this finding. The proposed options would improve the flexibility of the Scheme and enable regulatory focus to be directed towards potentially higher risk applications.
Finding 14:
The Academies strongly support this finding, which would enhance the responsiveness of the governance process while maintaining national accountability for the operation of the Scheme.
Finding 15:
The Academies strongly support this finding. International harmonisation of regulatory regimes promotes the exchange of knowledge and technology resources and provides certainty to both researchers and industry.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Finding 16:
The Academies support this finding.
Finding 17:
The Academies support this finding. National consistency is a critical enabler of effective collaborative research and innovation in all technology fields.
Finding 18:
The Academies acknowledge moratoria based on economic considerations are a policy matter for jurisdictions and have no comment on this finding.
Finding 19:
The Academies have no comment on this finding.
Finding 20:
While the Academies consider it important for the benefits of GM technology to be evaluated and understood, they should remain beyond the scope of the Gene Technology Scheme, which focusses appropriately on safety through the assessment and management of health and environmental risks. The benefits of GM technology should be considered in other fora.
Finding 21:
The Academies support this finding, and strongly support the principle that the level of regulation should be commensurate with risk.
Finding 22:
The Academies support the establishment of a forward work program for the Legislative and Governance Forum as proposed and would be keen to participate in consultations regarding Policy Principles, Policy Guidelines and Codes of Practice. This approach would provide policy clarity for stakeholders, increase transparency and enhance the operational effectiveness of the Scheme.
Finding 23:
The Academies support this finding. This will allow the Forum to provide clarity on policy matters, and to respond more rapidly to developments in technology or the regulatory environment.
Finding 24-26:
The Academies have no comment on these findings beyond noting that improving clarity about the role of the OGTR and the roles of the regulatory agencies is to be supported. The Academies strongly supports inter-agency harmonisation and a coherent, cross-government regulatory environment.
Finding 27:
The Academies strongly support this finding. Full cost recovery would add a financial burden to the already substantial regulatory burden and provide further disincentive to the use and development of gene technology.
Finding 28:
The Academies note the Review identified an increasing workload for the OGTR. The implementation of the report findings, if accepted, collectively represent an extensive future work program for the OGTR and the Department of Health, as well as other government bodies, that would require additional resourcing. Given that the Academies support the bulk of the Review's recommendations, they also support the resourcing of these activities.
The Academies support this finding.
Finding 17:
The Academies support this finding. National consistency is a critical enabler of effective collaborative research and innovation in all technology fields.
Finding 18:
The Academies acknowledge moratoria based on economic considerations are a policy matter for jurisdictions and have no comment on this finding.
Finding 19:
The Academies have no comment on this finding.
Finding 20:
While the Academies consider it important for the benefits of GM technology to be evaluated and understood, they should remain beyond the scope of the Gene Technology Scheme, which focusses appropriately on safety through the assessment and management of health and environmental risks. The benefits of GM technology should be considered in other fora.
Finding 21:
The Academies support this finding, and strongly support the principle that the level of regulation should be commensurate with risk.
Finding 22:
The Academies support the establishment of a forward work program for the Legislative and Governance Forum as proposed and would be keen to participate in consultations regarding Policy Principles, Policy Guidelines and Codes of Practice. This approach would provide policy clarity for stakeholders, increase transparency and enhance the operational effectiveness of the Scheme.
Finding 23:
The Academies support this finding. This will allow the Forum to provide clarity on policy matters, and to respond more rapidly to developments in technology or the regulatory environment.
Finding 24-26:
The Academies have no comment on these findings beyond noting that improving clarity about the role of the OGTR and the roles of the regulatory agencies is to be supported. The Academies strongly supports inter-agency harmonisation and a coherent, cross-government regulatory environment.
Finding 27:
The Academies strongly support this finding. Full cost recovery would add a financial burden to the already substantial regulatory burden and provide further disincentive to the use and development of gene technology.
Finding 28:
The Academies note the Review identified an increasing workload for the OGTR. The implementation of the report findings, if accepted, collectively represent an extensive future work program for the OGTR and the Department of Health, as well as other government bodies, that would require additional resourcing. Given that the Academies support the bulk of the Review's recommendations, they also support the resourcing of these activities.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
Finding 29:
The Academies support this finding.
Finding 30:
The Academies support this finding.
Finding 31:
The Academies acknowledge this finding, but consider genetically modified organisms to be appropriately regulated and so represent a relatively low risk to human or environmental health and safety. Given the increasing versatility of the technology, there will always remain potential for high-risk applications, but such risks can be identified and managed within the present regulatory environment provided that Scheme is enabled to respond to new developments in technology.
Finding 32:
The Academies consider the current post-release review mechanisms sufficient, but support increased communication efforts regarding decisions affecting gene technology post-release.
Finding 33:
The Academies support this finding. Transparency is one of the Scheme’s signature strengths.
The Academies support this finding.
Finding 30:
The Academies support this finding.
Finding 31:
The Academies acknowledge this finding, but consider genetically modified organisms to be appropriately regulated and so represent a relatively low risk to human or environmental health and safety. Given the increasing versatility of the technology, there will always remain potential for high-risk applications, but such risks can be identified and managed within the present regulatory environment provided that Scheme is enabled to respond to new developments in technology.
Finding 32:
The Academies consider the current post-release review mechanisms sufficient, but support increased communication efforts regarding decisions affecting gene technology post-release.
Finding 33:
The Academies support this finding. Transparency is one of the Scheme’s signature strengths.