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Calls for overhaul of gene-technology regulations

Calls for overhaul of gene-technology regulations and wide public discussion

An expert panel set up by Royal Society Te Apārangi to consider the implications of new technologies that allow much more controlled and precise ‘editing’ of genes, has concluded it’s time for an overhaul of the regulations and that there’s an urgent need for wide discussion and debate about gene editing within and across all New Zealand communities.

The Society convened the panel, along with a Māori reference group, to explore the implications of gene editing as well as capture Māori views and approaches to assessing this technology. The panel was not asked to come to a view about the merits or otherwise of any particular application of gene editing.

Expert panel Co-chair Dr David Penman said that there is a need to move on from a black and white view of “GM or not GM” – to a much more nuanced view that recognises a wide range of applications of the technology, some of which may be more acceptable to New Zealand communities than others.

He said that while there have been a number of international summits on the use of gene editing, it was important that New Zealand develop its own view.

“New Zealand needs to have its own perspective given our unique cultural heritage and environment, the special challenges we face in maintaining our biodiversity and a viable and productive primary industry, and our unique regulatory environment.

“Furthermore, there has been no review of gene technologies in New Zealand since the Royal Commission on Genetic Modification held in 2001 and the subsequent amendments to the Hazardous Substances and New Organisms Act (1996).”

The panel chose to consider the implications of the technology in parallel work streams using a range of scenarios in three areas:
• Healthcare;
• Environmental pest management; and
• Primary industries.

The panel produced summary discussion documents, as well as more-detailed technical descriptions, for each of the three scenario areas, and ran a number of public discussions and hui around the country to find out what information about gene editing would be helpful to inform communities. The panel also conducted an analysis of New Zealand’s legal and regulatory framework in the context of the scenarios considered.

Co-chair Barry Scott, Professor of Molecular Genetics at Massey University, says that for all three areas—health, pest control and primary industries—they heard views for and against the use of gene editing.

“In healthcare, there was an appetite to consider certain therapeutic gene-editing applications as long as it was safe and negative side effects are reduced or mitigated. Applications should improve wellbeing and be focussed on solutions to health issues.

“In pest control, there was some appetite to consider gene drives for pest management if the benefits outweighed the risks. However, there were concerns over unintended consequences of removing species and around the risks of gene-edited pests finding their way back to their native countries.

“In the primary industries, comments on the benefits of using gene-editing technology included that it could provide a useful tool for supporting competitive advantage, and for protecting New Zealand’s flora and fauna. There were concerns about unintended consequences, a need for better understanding of the relevant genetics, and that use of gene-editing technology would compromise the New Zealand brand and any ‘GM free’ competitive advantage.

“Across all scenarios, feedback from Māori participants highlighted the importance of whakapapa and mauri, involving tangata whenua around indigenous species, protection of data, and intellectual property implications of gene editing taonga species,” Professor Scott said.

The regulatory review identified a number of potential issues, including that the legal framework is becoming increasingly out of date given the global advances in gene-editing technology.

“The Panel would like to see a legal and regulatory system in New Zealand that is more future-proofed and ‘fit-for-purpose’ by being easier to navigate, having clear and consistent definitions, and providing a better basis for assessing the risks and opportunities of particular applications of gene editing rather than focusing on the gene-editing process itself.

“There is also an urgent need for a wide and well-informed discussion across New Zealand’s diverse communities about their preferences for application of gene editing, in order to inform any regulatory change.”

Royal Society Te Apārangi President Professor Wendy Larner said that this has been an important project for the Society.

“This work was needed to urgently inform an important national conversation about gene editing as its global development continues apace. There is a real risk of New Zealand communities being left behind. Royal Society Te Apārangi was arguably the best-placed organisation in the country to do this work given its independence and its access to the best expertise across New Zealand and globally. I am hopeful that the resources developed by this panel will be helpful to communities and the government in informing New Zealand’s future direction. ”

Revised scenario summary and technical documents, and the paper on the legal and regulatory framework, are available to view at royalsociety.org.nz/gene-editing

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