Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
Curtin University
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
Findings 3 and 4
We are very pleased to see that the review has recognised that the current definitions within the Act and the Gene Technology Regulations 2001 (the Regulations) are ambiguous and need to be improved upon. We have found that the definitions within the Act around what constitutes a GMO are less ambiguous and it is the extra definitions within the Regulations that have created confusion amongst members of the regulated community.
We are very pleased to see that the review has recognised that the current definitions within the Act and the Gene Technology Regulations 2001 (the Regulations) are ambiguous and need to be improved upon. We have found that the definitions within the Act around what constitutes a GMO are less ambiguous and it is the extra definitions within the Regulations that have created confusion amongst members of the regulated community.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
Findings 8, 9 and 10
We believe that the process trigger should be maintained as outlined in the findings. The approach of risk tiering certain types of organisms, or even processes, would greatly simplify the regulatory process and may make it easier for researchers to get approval to do work. We are therefore in support of this proposal. Added to this, the streamlining of processes through e solutions would drastically improve the experience of researchers and organisations. It is positive to see that the Office of the Gene Technology Regulator (OGTR) is already beginning to implement some of these changes.
Finding 13
Since the advent of new technologies such as RNAi, CRISPR and TALEN, we have found the response from the OGTR leaves considerable room for improvement. We understand that they have been constrained somewhat by the scheme that they must adhere to. The OGTR have been very reticent to provide advice on whether using non-vector mediated RNAi, CRISPR or TALEN constitutes a GMO. This has caused confusion within the regulated community. Finding 13 recommends giving the OGTR the power to make determinations on new technologies between reviews of the Scheme. We believe that this is an adequate solution to this issue.
We believe that the process trigger should be maintained as outlined in the findings. The approach of risk tiering certain types of organisms, or even processes, would greatly simplify the regulatory process and may make it easier for researchers to get approval to do work. We are therefore in support of this proposal. Added to this, the streamlining of processes through e solutions would drastically improve the experience of researchers and organisations. It is positive to see that the Office of the Gene Technology Regulator (OGTR) is already beginning to implement some of these changes.
Finding 13
Since the advent of new technologies such as RNAi, CRISPR and TALEN, we have found the response from the OGTR leaves considerable room for improvement. We understand that they have been constrained somewhat by the scheme that they must adhere to. The OGTR have been very reticent to provide advice on whether using non-vector mediated RNAi, CRISPR or TALEN constitutes a GMO. This has caused confusion within the regulated community. Finding 13 recommends giving the OGTR the power to make determinations on new technologies between reviews of the Scheme. We believe that this is an adequate solution to this issue.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
Finding 27 and 28
We agree that funding provided to the OGTR is not sufficient to meet future needs and only just covers their current needs. We do not believe that cost recovery, in any way, from non-commercial operators (such as universities, MRIs and government agencies) is appropriate. The majority of high-level dealings in the nation are being conducted by private industry; however, we do not advocate for cost recovery from these participants in the Scheme. As suggested in the review, cost recovery, especially to industry, may stifle innovation and international competitiveness and may drive these industries to take their research to other jurisdictions.
We agree that funding provided to the OGTR is not sufficient to meet future needs and only just covers their current needs. We do not believe that cost recovery, in any way, from non-commercial operators (such as universities, MRIs and government agencies) is appropriate. The majority of high-level dealings in the nation are being conducted by private industry; however, we do not advocate for cost recovery from these participants in the Scheme. As suggested in the review, cost recovery, especially to industry, may stifle innovation and international competitiveness and may drive these industries to take their research to other jurisdictions.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
We agree that the OGTR could be involved in more proactive community engagement (Finding 29 and 30). We acknowledge that this would likely need more resources to ensure that it is done effectively, however the benefits of this far out way any extra monetary cost.
To our mind some of the issues associated with findings 31 and 32 could be solved through more proactive community engagement. The majority of community groups are unaware of the full role that the OGTR plays and a better education strategy may alleviate these issues.
To our mind some of the issues associated with findings 31 and 32 could be solved through more proactive community engagement. The majority of community groups are unaware of the full role that the OGTR plays and a better education strategy may alleviate these issues.