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FNIH Panel on Gene Drive Regulation Emphasizes Need for Local Community Engagement

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NEW YORK – The development of new technologies — particularly those that change the genome in some way — has almost always been followed by a debate on their governance and regulation. In a bid to prevent the misuse of CRISPR gene editing technology, for example, several international commissions are developing guidelines for the scientific community and world governments on its proper usage and possible regulation.

Genetically modified organisms are another topic of deep debate, with some activists agitating for and getting governments to implement deep restrictions on modified crops. More recently, GMO crops have started to regain public favor, particularly in countries where boosting the levels of nutrients in staple crops could provide a benefit for children, or where certain genome modifications could increase crop yields.

But reversing public biases and, more importantly, governmental regulations against GMOs won't be a simple matter, even if scientists can show a benefit to the modifications. So, when it comes to the development of the gene drive — another gene modification technology meant to promote the spread of certain genes in organisms such as mosquitoes in order to control or eradicate their populations in a controlled manner — many researchers are determined to foster debate that focuses on the science, includes local communities in the discussion, and leads to governance and regulations that will benefit both the environment and human health.

In July, the Foundation for the National Institutes of Health (FNIH) launched the GeneConvene Global Collaborative, an initiative to advance the safe and responsible exploration of genetic biocontrol technologies such as gene drives, particularly with an eye towards controlling species such as mosquitos that cause malaria.

GeneConvene hosted a virtual discussion on Thursday on the regulatory and governance challenges posed by gene drives. In her presentation, Natalie Kofler — a molecular biologist and bioethicist, and the founding director of Editing Nature at Yale University — emphasized that because gene drive technology is meant to affect a shared environment, the communities that will feel the most direct impact should have a say in how the technology is used.

She noted that many organizations around the world have already called for community engagement. The World Health Organization published a position paper on genetically modified mosquitos in October, in which it said that "any effective approach to combating vector-borne diseases requires the robust and meaningful engagement of communities." In the US, the National Academies of Sciences, Engineering, and Medicine released a report in 2016 called Gene Drives on the Horizon with an entire chapter dedicated to engagement in local communities. This type of engagement can't be an afterthought, the NAS said. It requires careful planning and attention.

But the systems and infrastructures that are needed to support early and iterative planning with communities don't really exist at the moment, Kofler said. She noted the example of the recently approved plan to release more than 750 million genetically engineered mosquitoes in the Florida Keys. Though Oxitec's OX5034 mosquito is transgenic and thus not technically a gene drive, the principals of community engagement are very much the same, she said. The engineered Aedes aegypti mosquitos are male and carry a gene that, when they mate with wild female mosquitoes, causes the resulting larvae to die before reaching adulthood.

The US Environmental Protection Agency first began the regulatory process for the mosquito in September 2019, and at one point it opened a 30-day public comment period to solicit comments from the public in Florida and Texas, where the mosquitos were going to be released. Thousands of comments were submitted, including many from the public that asked for delays in the trials or a better understanding of what was going to happen.

Though the Florida Keys Mosquito Control Board eventually voted 4-to-1 to approve a field trial, the EPA public comment period was much too opaque over what comments were being taken into account, creating more distrust over the process and the transgenic technology itself, Kofler said.

To avoid this kind of problem in the future, many are calling for the development of a registry for gene drive technology, she added. This registry can be designed in such a way that empowers local community input. In addition, there needs to be more funding for independent research on these technologies to assess their risks, as opposed to funding that only comes from the technology developers, as well as the formation of an interdisciplinary advisory board to oversee what risks are assessed and how.

In thinking about the design of the registry, she added, there could be different portals for different audiences. For example, the information the community wants to see may not be what technologists need to see. Companies need to be encouraged to input their information, so there would be protection for patents, she added. And there needs to be a tool for accountability, so the scientists can show that they actually did engage with communities. There's also the question of whether this registry can eventually evolve into some kind of certification process.

When it comes to empowering local communities, Kofler said, the term "expert" needs to be expanded. Certainly, biologists, geneticists, ethicists, and technologists will all be needed. But given the nature of gene drives, the expertise of individuals such as indigenous peoples, victims of viral outbreaks, and naturalists should also be used, and these people should be engaged with early in a project, rather than as an afterthought.

Collaboration with such stakeholders is key, Kofler said, because scientists must know if the solution they're proposing to a given problem is going to serve the community rather than creating new problems for it later on.

She also noted that the question of consent is an important one in the case of gene drive technology, but that it's not enough. Current consent considerations are focused on individuals, but here, we're talking about communities and the environment that those communities are a part of. This type of science is going to require relationship building, and this must also factor into the regulatory process, she said.

Further, Kofler added, it's important for researchers to "grapple with the history of each community," including legacies of imperialism, colonialism, red-lining, and environmental racism. She called out the legacy of shameful episodes such as the Tuskegee syphilis trials, and said that researchers must take care that these projects don't hurt anyone's health and don't create more distrust in science.

And finally, she said, more funding is needed. There's always talk about the need for public engagement and discussion, but all the money goes into tech development and only a miniscule amount goes into the infrastructure and systems needed for public engagement.

International implications

These considerations, however, extend beyond the US. Much like with CRISPR germline genome editing, the local implications of gene drives can't be separated from the global considerations. After all, a mosquito doesn't stop to have its passport checked at the border.

In his presentation, Jesse Reynolds of the University of California, Los Angeles School of Law said there are already several international bodies and conventions that regulate or suggest governance for genetically modified organisms that could also work for gene drives. He noted, for instance, that in certain circumstances, they may fall under the United Nations' Biological Weapons Convention, or perhaps be governed under the World Trade Organization's trade laws.

The most likely framework, however, would be the Convention on Biological Diversity (CBD), Reynolds said. It's an international treaty with widespread participation, and the signatories are considered bound under international law (except the US, which participates but is not bound).

There are also ancillary agreements to the CBD, the most important of which in this case is the Cartagena Protocol on Biosafety. This agreement was signed in 2000 by 172 countries, and it regards the protection of in situ biodiversity, including promoting the recovery of threatened species, controlling and eradicating invasive species, and controlling the use of living modified organisms resulting from biotech.

Although the Cartagena Protocol itself may provide a baseline regulation framework for gene drive organisms, parties to the CBD have undertaken to update it specifically as it pertains to gene drives, Reynolds said.

Over the past six years or so, scientific organizations have been advocating for gene drives to control malaria and mosquito populations, with African countries taking a leadership role, while certain activist environmental groups have been advocating against gene drives, trying to link modified mosquitos to GMO crops.

In 2018, the parties to the CBD finally agreed to take a precautionary approach, saying that research and analysis are needed, and agreeing to consider gene drive trials on a scientific case-by-case basis with risk management measures in place and the needs of the indigenous communities in mind.

Interestingly, Reynolds said, the debate over gene drives in the international community is shaping up somewhat differently than the debate over GMOs. Largely, industrialized countries have similar positions on gene drives and GMOs and most gene drive opponents also opposed GMOs. But the positions of developing countries have differed on the two technologies, especially those of African countries.

Also, the private sector was quite active in pushing for GMO crops because they could control and keep the benefits largely private. Now, they're mostly absent from the gene drive debate, because the benefits are spread out and taken up by state and government actors. Whereas gene drives certainly do have future potential in agriculture, there still remains a difference from how they've been developed so far compared to GMOs, Reynolds added. GMOs were developed in the early days by private actors with a "veneer" of public benefit, but it's the inverse for gene drives, which are being developed significantly by public money and researchers, but with potential benefit later on for crops.

Importantly, Reynolds said, some scientists who were quiet on the issue of GMOs are now actively speaking out about the technology of gene drives because they regret letting activists frame the issues on crops and creating biases which are still shaping debate on the issue today.

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