Gene editing regulations – Expert Reaction

Published: Tue 13 Aug 2019 09:27 AM
It's time for an overhaul of the regulations around gene editing, according to an expert panel set up by Royal Society Te Apārangi.
The panel's findings follow earlier reports on gene editing in healthcare, primary industries and pest control. They have called for a more nuanced view of gene technologies, as some applications may be more acceptable to New Zealand communities than others.
The SMC gathered expert comments on the panel's findings.
Associate Professor Maui Hudson, University of Waikato, comments:
"The Royal Society report provides a well considered look at the regulatory inconsistencies present in New Zealand and highlights the need for a more nuanced approach to our management of gene technologies. The report also highlights the need to engage broadly with the community to ensure the uses of these new technologies is both proportionate to risk and align with social and cultural values.
"This outcome is consistent with recent Māori perspectives on gene editing which recognised that the changing scientific context and environmental pressures might require looking more closely at how gene based technologies might contribute to conservation and health outcomes."
Conflict of interest statement: Currently part of an MBIE funded project looking at the use of gene editing for horticulture. Maui published a paper on Indigenous Perspectives and Gene Editing in Aotearoa New Zealand earlier this year, in collaboration with members of the Gene Editing panel.
Dr Hilary Sheppard, Senior Lecturer, School of Biological Sciences, Auckland, comments:
"The Royal Society Te Apārangi has convened a multidisciplinary panel of New Zealand experts to examine the implications and issues to New Zealand of rapidly developing genetic technologies such as gene editing.
"Gene editing allows us to change gene sequences with unprecedented ease and specificity. As such it is a powerful tool that has the potential to significantly impact many sectors including healthcare, agriculture and conservation. The versatility of gene editing means that we need to think carefully, as a society, about the various and varied scenarios to which this tool can be applied and to decide if we find specific applications to be scientifically, ethically and morally acceptable. As such this report is timely.
"Historically gene modification has been an emotive and polarising issue. However, the benefits that gene editing can bring to society demand that we re-examine our position. We need to provide a legislative framework that allows for risk-tiered regulations to govern current and future biotechnological advances.
"The main findings of this report are: 1) the need for a nuanced definition of genetic modification, 2) the requirement for a simple, risk-tiered and consistent regulatory landscape that aligns with international regulations, and 3) a commitment to build capability that will allow for community-wide engagement to support sensible decisions as we develop policy around genetic technologies.
"The report highlights the fact that we need to ensure that our legislation keeps pace with the rapidly advancing technology – currently it has been left far behind. As an example, in the course of our lab-based research we use gene editing to fix disease-causing mutated genes in cells taken from informed and consenting patients. Once they have been repaired using gene-editing tools, these cells are currently classified as ‘new organisms’ under the HSNO Act. This is true if we fix only the very smallest segment of a gene to generate the normal version of the gene that is present in most people. Clearly, we have some legislative issues to deal with as currently these repaired cells are not allowed out of the laboratory, regardless of how useful they may to a patient’s health and well-being.
"The Royal Society panel correctly suggest that as legislation and regulations evolve they should focus on an outcome-based approach rather than a process-based approach. I agree as currently, for example, I could expose a patient’s cells to irradiation in the laboratory – this would induce random and widespread mutagenesis, but these cells would NOT be considered as ‘new organisms’. These cells could leave the laboratory despite the fact that they would have uncontrolled, and many more, genetic changes than a gene-edited cell.
"The Royal Society has done a great job of highlighting the issues that New Zealand currently faces as it grapples to effectively regulate new genetic technologies. They have underlined the need for a widespread and informed discussion. To this end, they have created some really useful on-line resources to aid that process. To my mind, the challenge now is to work out exactly how we can have a meaningful, community-wide discussion. And will sufficient resources be allocated to achieve this in a timely and effective manner?"
Conflict of interest statement: I am leading lab-based research that uses gene-editing in patient cells.
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