Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
QIMR Berghofer MRI
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
QIMR Berghofer supports further work required to achieve consistent definitions in the Act and the Regulations, and the necessity of seeking viewpoints from a wide range of stakeholders (including international stakeholders).
QIMR Berghofer recognises that some stakeholders during the consultation process raised concerns about off-target effects of technologies such as ODM, SDN-1 and SDN-2. Additional work is required before a conclusion can be reached on how the organisms created by these technologies can be classified. However, QIMR Berghofer has concerns that regulating organisms created by these technologies, where the resulting organism is indistinguishable from that found in nature, will be difficult to monitor and regulate. This may detract from the credibility of the legislative process.
Furthermore, QIMR Berghofer does not support the approach which would require whole genome sequencing for every GMO organism created by these methods (e.g. mammalian cell lines, plants, mice) to confirm the absence of off-target effects. QIMR Berghofer sees merit in whole genome sequencing of new GMOs where they are released into environment and/or as an option to remove GMOs created by these technologies from regulation prior to release. However, this requirement is considered unnecessarily burdensome and resource intensive for dealings remaining in certified facilities.
QIMR Berghofer supports a regulatory framework involving GMOs that maintains Australia’s international competitiveness. A uniquely costly or onerous regulatory framework (out of step with EU or the Americas) will be damaging to Australia’s research endeavours and economy in general. Although supported by some stakeholders, placing a moratorium on all GM gene drive research (both contained dealings and those involving environmental release) because of their potential to spread through the environment would be counterproductive. QIMR Berghofer believes that gene drive work that is a contained dealing should be able to be effectively managed as an NLRD under the current framework, but supports the proposal that gene drive dealings involving environmental release should be carefully considered on a case-by-case basis.
QIMR Berghofer agrees that the scheme should not expand to be the primary regulator of human gene therapies. However, a joint approach should be considered, e.g. TGA and OGTR, in human gene therapy trials where oversight is required from multiple ethical and regulatory perspectives. Trials should be considered on a case-by-case basis rather than by set rules due to the fast changes in the scientific field. Having gone through the process of setting up a clinical trial involving administration of modified T cells into humans, QIMR Berghofer found that sequentially meeting the requirements of the two regulators, rather than via a concurrent, coordinated regulatory assessment, was time consuming. To maximise benefits to public health, research progress and economic development, where possible, a coordinated approval process should be trialled.
When it comes to environmental release of GMOs, QIMR Berghofer recommends any agency tasked with evaluating such a release ensures a broad range of external technical experts are consulted. The consultation process should be focussed on gathering information on which a logical and risk based GMO release decision can be made.
QIMR Berghofer recognises that some stakeholders during the consultation process raised concerns about off-target effects of technologies such as ODM, SDN-1 and SDN-2. Additional work is required before a conclusion can be reached on how the organisms created by these technologies can be classified. However, QIMR Berghofer has concerns that regulating organisms created by these technologies, where the resulting organism is indistinguishable from that found in nature, will be difficult to monitor and regulate. This may detract from the credibility of the legislative process.
Furthermore, QIMR Berghofer does not support the approach which would require whole genome sequencing for every GMO organism created by these methods (e.g. mammalian cell lines, plants, mice) to confirm the absence of off-target effects. QIMR Berghofer sees merit in whole genome sequencing of new GMOs where they are released into environment and/or as an option to remove GMOs created by these technologies from regulation prior to release. However, this requirement is considered unnecessarily burdensome and resource intensive for dealings remaining in certified facilities.
QIMR Berghofer supports a regulatory framework involving GMOs that maintains Australia’s international competitiveness. A uniquely costly or onerous regulatory framework (out of step with EU or the Americas) will be damaging to Australia’s research endeavours and economy in general. Although supported by some stakeholders, placing a moratorium on all GM gene drive research (both contained dealings and those involving environmental release) because of their potential to spread through the environment would be counterproductive. QIMR Berghofer believes that gene drive work that is a contained dealing should be able to be effectively managed as an NLRD under the current framework, but supports the proposal that gene drive dealings involving environmental release should be carefully considered on a case-by-case basis.
QIMR Berghofer agrees that the scheme should not expand to be the primary regulator of human gene therapies. However, a joint approach should be considered, e.g. TGA and OGTR, in human gene therapy trials where oversight is required from multiple ethical and regulatory perspectives. Trials should be considered on a case-by-case basis rather than by set rules due to the fast changes in the scientific field. Having gone through the process of setting up a clinical trial involving administration of modified T cells into humans, QIMR Berghofer found that sequentially meeting the requirements of the two regulators, rather than via a concurrent, coordinated regulatory assessment, was time consuming. To maximise benefits to public health, research progress and economic development, where possible, a coordinated approval process should be trialled.
When it comes to environmental release of GMOs, QIMR Berghofer recommends any agency tasked with evaluating such a release ensures a broad range of external technical experts are consulted. The consultation process should be focussed on gathering information on which a logical and risk based GMO release decision can be made.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Having a legislated review of the Gene Technology Regulations 2001 every five years provides a chance for an update of the Regulations while maintaining transparency and oversight. However, this timeframe is too long when compared with the rate at which gene technology changes.
Hence, the findings and recommendations reported in Findings 3, 9, 10, 11 and 13 are welcome. As the implementation of some of these findings may result in the OGTR having increased power to define changes to the scheme, it is agreed that the oversight bodies and committees within the scheme should also be given increased powers or provide more operational input (Findings 13, 14, 22). QIMR Berghofer supports the proposal to streamline the system as outlined in Finding 10, through the use of IT solutions and providing greater oversight/responsibilities to IBCs.
If improved and more layered risk tiering, and a legislative scheme allowing for easier updates to the Regulations were implemented, the OGTR will need to ensure there is well targeted and executed communication with stakeholders.
QIMR Berghofer suggests that a system of principles-based regulation should be considered in some cases, especially where it may apply to lower risk dealings, to improve flexibility and the ability to respond rapidly to a changing technological environment.
Hence, the findings and recommendations reported in Findings 3, 9, 10, 11 and 13 are welcome. As the implementation of some of these findings may result in the OGTR having increased power to define changes to the scheme, it is agreed that the oversight bodies and committees within the scheme should also be given increased powers or provide more operational input (Findings 13, 14, 22). QIMR Berghofer supports the proposal to streamline the system as outlined in Finding 10, through the use of IT solutions and providing greater oversight/responsibilities to IBCs.
If improved and more layered risk tiering, and a legislative scheme allowing for easier updates to the Regulations were implemented, the OGTR will need to ensure there is well targeted and executed communication with stakeholders.
QIMR Berghofer suggests that a system of principles-based regulation should be considered in some cases, especially where it may apply to lower risk dealings, to improve flexibility and the ability to respond rapidly to a changing technological environment.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
QIMR Berghofer supports a nationally consistent regulatory framework, but notes the interdependency of State legislation and Commonwealth legislation. QIMR Berghofer believes that in instances where the OGTR overlaps with some product regulators there is a possibility for time saving by having a single application process (e.g. clinical trials of genetically modified immune cells where both the OGTR and the TGA need to be involved).
The proposed increase in scheme flexibility and information technology resources prompts significant concerns around the funding and sustainability of the scheme. While much medical research is funded by the Federal Government in Australia, a number of factors (including the low average success rate of competitive NHMRC grants at 19.3%, the current focus on controlling government spending, and the overall financial pressures on the research industry), have created a tight fiscal environment for all research involving the use of gene technology.
Implementing a full cost recovery model for gene technology, a central tool in modern research, will create excessive costs for organisations and/or individual research group budgets, or both, and will increase administrative burden. For example, full cost recovery is already an issue for compliance with the Biosecurity Act 2015, with many research industry stakeholders believing that the cost of regulation is not commensurate with the risks associated with activities. QIMR Berghofer does not support a full cost recovery model and believes that fees should be levied only when the consideration of a dealing involves substantial investment of OGTR resources (e.g. certain DIRs).
Data sharing and harmonisation of processes across different Commonwealth departments, as discussed in the lead up to Findings 24, 25, and 26, has the potential to benefit the research community. The implementation of a web portal incorporating well-structured decision-making is also welcomed (Findings 10 and 24).
The proposed increase in scheme flexibility and information technology resources prompts significant concerns around the funding and sustainability of the scheme. While much medical research is funded by the Federal Government in Australia, a number of factors (including the low average success rate of competitive NHMRC grants at 19.3%, the current focus on controlling government spending, and the overall financial pressures on the research industry), have created a tight fiscal environment for all research involving the use of gene technology.
Implementing a full cost recovery model for gene technology, a central tool in modern research, will create excessive costs for organisations and/or individual research group budgets, or both, and will increase administrative burden. For example, full cost recovery is already an issue for compliance with the Biosecurity Act 2015, with many research industry stakeholders believing that the cost of regulation is not commensurate with the risks associated with activities. QIMR Berghofer does not support a full cost recovery model and believes that fees should be levied only when the consideration of a dealing involves substantial investment of OGTR resources (e.g. certain DIRs).
Data sharing and harmonisation of processes across different Commonwealth departments, as discussed in the lead up to Findings 24, 25, and 26, has the potential to benefit the research community. The implementation of a web portal incorporating well-structured decision-making is also welcomed (Findings 10 and 24).
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
QIMR Berghofer supports actions to ensure the regulatory scheme is transparent and is communicated appropriately to the public. QIMR Berghofer agrees that it is appropriate for the Gene Technology Regulator to continue to lead communication in this arena.
With respect to the broader societal impacts, QIMR Berghofer suggests that more emphasis could be given to communicating health benefits which can be accomplished through the use of GMOs (e.g. vaccines and non-food related GMOs).
With respect to the broader societal impacts, QIMR Berghofer suggests that more emphasis could be given to communicating health benefits which can be accomplished through the use of GMOs (e.g. vaccines and non-food related GMOs).