Introduction
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Australian National University
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
The ANU is in broad agreement with the findings of the review relating to technical issues.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
The ANU is in broad agreement with the findings of the review relating to regulatory issues apart from some aspects of Finding 10.
Finding 10 suggests that there may be IT solutions to streamline current regulatory requirements such as certification applications and licence applications. Whilst this might make the application process more efficient for the accredited organisation it would not address the more fundamental and important problem of limited OGTR resources to process these applications more quickly. Whether an application arrives in the existing format or in electronic format, it still requires a person to assess the application. We do not believe the benefits proposed for IT solutions are sufficient to warrant specific mention in Finding 10 and are in fact misleading because they do not address the real source of the problem.
We are also concerned about two of the streamlining proposals shown in Table 1.
1) The suggestion that ‘Amending NLRD reporting requirements so that organisations report to their IBC, rather than the OGTR’ seems absurd and we wondered whether this suggestion has been misrepresented or not stated clearly. At the ANU, and presumably many other accredited organisations, the IBC prepares the annual report to the OGTR. The absurd outcome of this recommendation as it stands would be the IBC reporting to itself. Moreover, the question arises of how the OGTR would maintain a register of NLRDs and therefore transparency of the scheme if accredited organisations or their IBCs did not provide annual reports to the OGTR. In our opinion, this suggestion needs restating more clearly, possibly with some caveats, or removed altogether.
2) The suggestion that all DNIR authorisations should be devolved to IBCs seems too extreme and certainly does not reflect the ANU position that some DNIR applications could be devolved to IBCs. We would recommend insertion of the word ‘some’ in the phrase ‘Devolving IR authorisations to IBCs’ consistent with the wording used later for DIRs i.e. ‘Devolving some DIR authorisations to IBCs’.
Finding 10 suggests that there may be IT solutions to streamline current regulatory requirements such as certification applications and licence applications. Whilst this might make the application process more efficient for the accredited organisation it would not address the more fundamental and important problem of limited OGTR resources to process these applications more quickly. Whether an application arrives in the existing format or in electronic format, it still requires a person to assess the application. We do not believe the benefits proposed for IT solutions are sufficient to warrant specific mention in Finding 10 and are in fact misleading because they do not address the real source of the problem.
We are also concerned about two of the streamlining proposals shown in Table 1.
1) The suggestion that ‘Amending NLRD reporting requirements so that organisations report to their IBC, rather than the OGTR’ seems absurd and we wondered whether this suggestion has been misrepresented or not stated clearly. At the ANU, and presumably many other accredited organisations, the IBC prepares the annual report to the OGTR. The absurd outcome of this recommendation as it stands would be the IBC reporting to itself. Moreover, the question arises of how the OGTR would maintain a register of NLRDs and therefore transparency of the scheme if accredited organisations or their IBCs did not provide annual reports to the OGTR. In our opinion, this suggestion needs restating more clearly, possibly with some caveats, or removed altogether.
2) The suggestion that all DNIR authorisations should be devolved to IBCs seems too extreme and certainly does not reflect the ANU position that some DNIR applications could be devolved to IBCs. We would recommend insertion of the word ‘some’ in the phrase ‘Devolving IR authorisations to IBCs’ consistent with the wording used later for DIRs i.e. ‘Devolving some DIR authorisations to IBCs’.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
The ANU is in broad agreement with the findings of the review relating to governance issues apart from some aspects of Finding 20.
Finding 20 argues ‘that consideration of benefits (e.g. potential economic, environmental and health benefits) should not be introduced at this time as it could risk the effective operation of the Scheme. In our opinion this is an overly cautious finding. All regulation is a balance of benefit and risk. Sole focus on risk may restrict the uptake of important innovations in Australia. Whilst we agree that risk should be the primary consideration, work needs to be done in preparation for the next future review of the Scheme on how benefits (especially those that might be required urgently) could or should be considered alongside risk and we believe the findings from the current review should reflect this need.
Finding 20 fails to distinguish adequately between economic benefits and health and environmental benefits. Historically, economic drivers have been a source for loss of public confidence in gene technology and we agree that a consideration of economic benefits could be counter-productive to public confidence in the scheme. On the contrary, environmental and health benefits are potentially a source of public support for gene technology (and in some cases already are).
Finding 20 is ambiguous about what is meant by ‘operation of the Scheme’. It should be made clear whether this finding refers to the way in which GMOs are assessed, categorised and regulated or to matters of public trust or both.
Finally, Finding 20 is somewhat inconsistent with Finding 26 which, based on the TGA example given, would seem to propose that benefit be taken into account under some circumstances and that “there may be benefit in additional investigation being undertaken”. Indeed, this is exactly the action that we have proposed above should be taken in relation to Finding 20. Moreover, Finding 20 should perhaps reference Finding 26.
Finding 20 argues ‘that consideration of benefits (e.g. potential economic, environmental and health benefits) should not be introduced at this time as it could risk the effective operation of the Scheme. In our opinion this is an overly cautious finding. All regulation is a balance of benefit and risk. Sole focus on risk may restrict the uptake of important innovations in Australia. Whilst we agree that risk should be the primary consideration, work needs to be done in preparation for the next future review of the Scheme on how benefits (especially those that might be required urgently) could or should be considered alongside risk and we believe the findings from the current review should reflect this need.
Finding 20 fails to distinguish adequately between economic benefits and health and environmental benefits. Historically, economic drivers have been a source for loss of public confidence in gene technology and we agree that a consideration of economic benefits could be counter-productive to public confidence in the scheme. On the contrary, environmental and health benefits are potentially a source of public support for gene technology (and in some cases already are).
Finding 20 is ambiguous about what is meant by ‘operation of the Scheme’. It should be made clear whether this finding refers to the way in which GMOs are assessed, categorised and regulated or to matters of public trust or both.
Finally, Finding 20 is somewhat inconsistent with Finding 26 which, based on the TGA example given, would seem to propose that benefit be taken into account under some circumstances and that “there may be benefit in additional investigation being undertaken”. Indeed, this is exactly the action that we have proposed above should be taken in relation to Finding 20. Moreover, Finding 20 should perhaps reference Finding 26.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
The ANU is in broad agreement with the findings of the review relating to social and ethical issues, but we thought that there was significant overlap between Findings 30 and 33 and consideration should therefore be given to their amalgamation.