Gene Editing Reflections from the Panel Co-Chairs Scenario Summaries + Scenarios (Healthcare, Pest Control and Primary Industries) Legal and Regulatory Implications
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ROYAL SOCIETY TE APĀRANGI GENE EDITING REFLECTIONS FROM THE PANEL CO-CHAIRS SCENARIO SUMMARIES + SCENARIOS (HEALTHCARE, PEST CONTROL AND PRIMARY INDUSTRIES) LEGAL AND REGULATORY IMPLICATIONS AUGUST 2019 TŪHURA TOROHĒ TOHATOHA CONTENTS GENE EDITING REFLECTIONS FROM THE PANEL CO-CHAIRS GENE EDITING GENE EDITING SCENARIOS IN SCENARIOS HEALTHCARE SUMMARY IN HEALTHCARE GENE EDITING GENE EDITING SCENARIOS IN PEST SCENARIOS CONTROL SUMMARY IN PEST CONTROL GENE EDITING GENE EDITING SCENARIOS IN THE SCENARIOS PRIMARY INDUSTRIES IN THE PRIMARY SUMMARY INDUSTRIES GENE EDITING LEGAL AND REGULATORY IMPLICATIONS ROYAL SOCIETY TE APĀRANGI GENE EDITING REFLECTIONS FROM THE PANEL CO-CHAIRS BARRY SCOTT AND DAVID PENMAN AUGUST 2019 Nā te iahia kia titiro, ā, ka kite ai tātou te mutunga. You must understand the beginning if you wish to see the end. 02 | ROYAL SOCIETY TE APĀRANGI GENE EDITING REFLECTIONS FROM THE PANEL CO-CHAIRS | 03 GENE EDITING: REFLECTIONS FROM THE PANEL CO-CHAIRS BARRY SCOTT AND DAVID PENMAN Random mutagenesis and selection in nature In response to these advances, many reports have has underpinned evolution and diversity of all been released and summits organised by academies life and the resulting domestication of plants and and research organisations around the world to animals. In modern times, advances in science and explain the technology, the context in which it is technology have allowed humankind to augment this being used, the issues that arise for society, and natural process in increasingly sophisticated ways the impact of these scientific advances on current through selective breeding programmes and the regulatory frameworks. Prominent among these was use of techniques such as irradiation and chemical the “International Summit on Human Gene Editing” mutagenesis to enhance the rate of gene mutation. organised by the US National Academies of Sciences and Medicine, the Royal Society (London) and the The development of a number of DNA technologies, Chinese Academy of Sciences in late 2015 to discuss and our ability to sequence entire genomes, has guidelines for the use of gene editing in humans. opened the door to modifying specific genes to generate new traits and characteristics. The These international reviews and summits have publication by Doudna, Charpentier and colleagues been immensely helpful in informing the public, in 2012, demonstrating how a bacterial system researchers and regulatory bodies around the world, for adaptive immunity called CRISPR-Cas9 could including New Zealand, and providing a framework be engineered to precisely edit genomes, has set for engaging internationally. However, New Zealand in motion a revolution in biology. It has been quite needs to have its own perspective given our unique astounding how quickly laboratories around the cultural heritage and environment, the special world have adopted this new tool for applications challenges we face in maintaining our biodiversity across biology, from modifying plants, to altering and a viable and productive primary industry, and insect development and potential treatment our unique regulatory environment. Furthermore, of some human diseases. The relative ease with there has been no review of gene technologies in which genomes can now be sequenced and edited New Zealand since the Royal Commission on Genetic has generated considerable excitement within the Modification held in 2001 and the subsequent scientific community. However, it has also raised amendments to the Hazardous Substances and New significant concerns about the social, legal and Organisms Act (1996). The field of genome science ethical issues raised by the use of the technology, has advanced dramatically since then, especially none more so than the potential to edit genes the ability to sequence organism genomes and to in human embryos. manipulate those genomes in a very precise way. GENE EDITING REFLECTIONS FROM THE PANEL CO-CHAIRS | 03 ROYAL SOCIETY TE APĀRANGI GENE EDITING PANEL AND MĀORI REFERENCE GROUP Royal Society Te Apārangi, as an independent The panel chose to consider the implications science body, has a function under its Act to of the technology in parallel work streams using provide expert advice on important public issues a range of scenarios in three areas: healthcare, to the Government and the community. In 2016, environmental pest management and primary the Society initiated a programme of work to explore industries. The scenarios are illustrative – they are the implications of gene editing technology for New not panel recommendations for priorities for New Zealand, motivated by the importance of this rapidly Zealand application. They are presented in a stepped advancing science, the need to raise awareness of approach of increasing potential risk averseness its potential applications, and to support informed and near and long-term benefits, to challenge and discussion and debate about its implications for promote public engagement, and test the current New Zealanders. regulatory regime. Each set of scenarios aimed to consider potential ethical, cultural and legal issues The first output of this programme was a short alongside the opportunities and potential risks and document entitled “Gene editing. Evidence benefits. This approach proved to be a productive update”, released in November 2016. This provided one for initiating a conversation with the New background on gene modification technologies Zealand public. and their evolution for the media, educators, policy makers and the public. Royal Society Te Apārangi Sitting behind the scenarios are technical papers then convened a multidisciplinary panel of experts, that provide a more comprehensive overview of the supported by a Māori reference group, to consider research evidence base and implications for each the social, cultural, legal and economic implications of the three areas. These are fully referenced for of gene-editing technologies for New Zealand. This readers to access the primary literature relevant to paper outlines the approach of the panel and makes each area considered, and have been peer reviewed some concluding observations. nationally and internationally. The panel was not asked to come to a view about New territory for Royal Society Te Apārangi was the merits or otherwise of any particular application to enlist the support of a Māori Reference Group of gene editing. Rather, its role has been to provide to assist the panel in capturing Māori views and information and resources that will allow others to approaches to assessing this technology. While the have well informed discussions and debates. Indeed, papers reflect particular ways in which some Māori one of the panel’s main observations is that there would assess their use of gene editing technology, is an urgent need for wide discussion and debate the panel observed wide diversity in views across about gene editing within and across all New Zealand both Māori and non-Māori communities. communities, as global research and development in applications of gene editing is continuing apace. Some countries are reviewing, or have already reviewed, their regulations in response to these developments. 04 | ROYAL SOCIETY TE APĀRANGI GENE EDITING REFLECTIONS FROM THE PANEL CO-CHAIRS | 05 PUBLIC FEEDBACK Other innovations for Royal Society Te Apārangi • In the primary industries, comments on the in this process were the publication of material benefits of using gene-editing technology in a series of discrete work pieces over time rather included that it could provide a useful tool than one large report, and initially publishing for supporting competitive advantage, and for the scenarios in draft form to allow feedback. protecting New Zealand’s flora and fauna. There This enabled the panel to undertake a series of were concerns about unintended consequences, engagement workshops around the country to seek a need for better understanding of the relevant feedback and identify additional information that genetics, and that use of gene-editing technology could be covered in the final technical papers. Senior would compromise the New Zealand brand and school students attended some of these sessions any “GM free” competitive advantage. and the panel invited informal comment via the • Across all scenarios, feedback from Māori Society’s website. Two hui were specifically aimed participants highlighted the importance of at Māori communities. whakapapa and mauri, involving tangata whenua This feedback process targeted testing the around indigenous species, protection of data, and information in the documents for completeness intellectual property implications of gene editing and usefulness – undertaking a comprehensive taonga species. national consultation was beyond the resources • Royal Society Te Apārangi was criticised on and mandate of Royal Society Te Apārangi and the occasions for appearing to take an advocacy panel. A number of themes were apparent from position on gene editing through its publication these interactions: of scenarios. • For all three themes, there were views for and • The Society also received considerable positive against the use of gene editing. feedback on undertaking the work and its use of scenarios. The society was often encouraged to • In healthcare, there was an appetite to consider lead a much wider engagement with communities certain therapeutic gene-editing applications given its independence and scientific standing. as long as it was safe enough to rule out negative side effects, and that it would enhance human • The