Abstract
The COVID-19 pandemic has brought forth a number of biotechnological advances to enhance the public's health: new diagnostic tests, mRNA vaccines, and new antiviral medications. Biotechnology is also being used to address global challenges like climate change, food insecurity, and building the bioeconomy, which directly or indirectly improve public health. Gene drives are one such biotechnology. They are genetically engineered systems that can alter the inheritance patterns in a host species, such as a mosquito, so that a greater percentage of its progeny inherit a specific desired trait. Research and investments in biotechnology have been used to reduce arthropod-borne infectious diseases, such as malaria and Zika, and to manage or eliminate invasive species. 2 Funding thus far has been adequate. For example, Target Malaria, a global consortium of researchers developing a gene drive to decrease the burden of malaria, has an average of US$11.5 million per year in funding. 3 Although no gene drive has been released into the environment yet, technologies with similar attributes have been released in field trials, notably by Oxitec in Florida. 4
While advances in biotechnology, especially gene drives, have enormous potential to mitigate several of the largest challenges faced by our society today, these technologies also pose risks. For gene drives specifically, concerns have been expressed about the potential ecological and environmental consequences that might arise from releasing gene drives into the wild, where some are expected to be able to self-propagate and self-sustain themselves indefinitely. 2 Additionally, these gene drives would be considered genetically modified organisms (GMOs) and could spread across borders without human knowledge.
It is the responsibility of stakeholders to mitigate the risks of biotechnologies. National governments, in particular, are responsible for implementing appropriate governance measures for biotechnologies like gene drives to provide oversight, empower the public, and protect human, animal, and environmental health. Some countries have laws specifically governing the farming of GMOs, but few have laws or regulations specific to gene drives and similar technologies that may alter wild population structures with limited human involvement postrelease. 5 Several international efforts—led by United Nations agencies such as the World Health Organization and International Union for the Conservation of Nature as well as the Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety to the CBD—are underway to create governance frameworks for such technologies. However, gaps remain as there is a lack of coordination between entities, and not all countries are signatories to the CBD.6,7
The United States is 1 of 4 countries that have not signed the CBD and is not a party to the Cartagena Protocol. 8 In the United States, the regulation of biotechnologies like gene drives is covered by the Coordinated Framework for Biotechnology Products, 9 which is primarily governed by the US Environmental Protection Agency, the US Department of Agriculture, and the US Food and Drug Administration. Established in 1986, and updated in 1992, the Coordinated Framework focuses upon the properties and application of the regulated product rather than the technologies used to build the product. Another update is needed to address gene drives, as their properties are sufficiently different from more traditional GMOs, and guidance should be added on how to empower and educate the public on these newer technologies.
As research and investment in gene drives advances and there are bigger pushes to expand the bioeconomy more broadly, it will be important to have governance frameworks in place before these biotechnologies are widely used. The COVID-19 pandemic has demonstrated how quickly needs may arise and how biotechnological advances are well suited to solve them. It has also shown, in the United States especially, that not having clear guidelines and governance measures can severely harm the public health response. In the case of gene drives, a field release by a company of a gene drive-like product has already occurred in the United States. It is imperative that the US federal government strengthen its governance framework for these technologies before more are introduced.
This special feature was developed to highlight different considerations and options that could be used to develop governance options for gene drives in the United States. The 5 papers in this special feature each explore different aspects of governance. Goldsmith et al 10 examine stakeholder opinions on gene drives for agricultural pest management. As public engagement and input is imperative for gene drives, this study provides critical information for federal authorities and other stakeholders funding or conducting gene drive research. In their article, Overcash and Golnar 11 examine how gene drives may be classified and what the impact of classification may be on governance options, particularly in the United States. In “iGEM and Gene Drives: A Case Study for Governance,” 12 Millet et al present how the international biotechnology competition iGEM has handled biosafety and biosecurity oversight for projects that have included a gene drive. Results from their experience working in a fast-paced environment may be analogous to what is needed for governance across the United States. In their case study, Vinke et al 13 assess the level of awareness of and attitudes toward nonpathogen dual-use research among students in life sciences. Their findings could help inform the development of curricula in biosecurity, ethics, and societal context for students and trainees working on gene drives and similar biotechnologies. Finally, “The Need for a Tiered Registry for US Gene Drive Governance” 14 by Warmbrod et al lays out a potential governance framework for gene drives and similar technologies in the United States.
These papers highlight considerations that should be made and propose several options for the development of US gene drive governance. These pieces should be seriously considered by governmental actors, so that mechanisms for gene drive governance may be introduced now, before gene drives are commonly used in the United States and around the world.