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The Need for a Tiered Registry for US Gene Drive Governance

Kelsey Lane Warmbrod, Amanda L. Kobokovich, Rachel West, Gigi Kwik Gronvall, and Michael Montague
Date posted:
January 11, 2022
Publication type:
Health Secur. 2022 January
Mary Ann Liebert, Inc.
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Scientists have explored gene drive technologies with the aim of controlling vector-borne diseases, including malaria, which killed an estimated 386,000 people in 2019.1 Gene drives are genetic modifications that can be used to create populations where a particular gene is passed from a parent organism to its offspring at a higher rate than would be expected under natural inheritance conditions.2 For example, mosquitoes that transmit malaria may be modified with a gene drive so that surviving offspring inherit and spread a gene that inhibits or alters the mosquitoes' infection potential. The drive would spread over subsequent generations, resulting in limited malaria transmission. Other gene drive strategies are designed to dramatically reduce the population of the carrying organism, such as a mosquito. Due to the broad-acting and potentially irreversible nature of these tools, current regulations may not be sufficient to mitigate the unique risks posed by gene drive technologies.3

A great deal of attention has been focused on the potential risks of gene drives, the kinds of biosafety protections they may require, and how they may be reversed; however, less attention has been paid to the systems that would be useful to have in place in the future, when multiple gene drives may be fielded in multiple species, environments, and countries.4-7 The need for coordinated governance of these technologies will become more pressing as gene drive technologies advance and more drives are created to address other vector-borne diseases like the West Nile virus, agricultural pest management, or invasive species. Gene drives carry different inherent risks compared with other genetically modified organisms (GMOs). Existing governance mechanisms for traditional GMOs are insufficient for oversight of gene drives, which require different systems to assess their usefulness and safety. To address the needs for enhanced oversight, we propose a tiered registry system, similar to the clinical trials databases, which can provide government officials, researchers, biotechnology companies, and the public with useful information about ongoing gene drive research or previously released gene drives. Such a resource would enable scientists to confirm that new gene drives would not interfere with existing drives, provide the public with the information needed to make informed decisions concerning consent for release of gene drives, provide researchers with technical information needed to prevent collisions of independent projects modifying the same organism, and provide regulators with information critical for effective oversight. We propose that the US government should implement such a registry for gene drives in the United States, which does not have a robust gene drive regulatory system in place and is not party to the international treaty most relevant for international gene drive regulation, the Convention on Biological Diversity.8 In this commentary, we describe current efforts to safely regulate gene drive and similar genetic technologies worldwide and how the United States could build a tiered registry database that is specifically designed to regulate such technologies throughout a drive's life cycle.



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