Many existing oversight mechanisms established for other technologies will be relevant for genetically modified mosquitoes. These include mechanisms for other genetically modified organisms, for other vector control tools, and for other public health interventions. The World Health Organization (WHO) has issued guidance for testing genetically modified mosquitoes, describing considerations for safety and efficacy testing at every stage of development and implementation as well as relevant institutional and regulatory oversight bodies and policies.

For more information:
https://www.who.int/publications/i/item/9789240025233

The first level of review of plans and protocols for research and testing is likely to be performed by oversight bodies housed at the involved research institutions, although in some countries such committees may function at the national level. Institutional Biosafety Committees may draft institutional biosafety policies and procedures and review individual research proposals for protection of health and the environment. Institutional ethics committees, also known as institutional review boards or ethical review boards, provide oversight for biomedical and behavioral research involving humans with the aim of protecting the rights and welfare of research participants. Communities where testing is proposed must be consulted on and agree to the research plans.

For more information:

https://www.who.int/publications/i/item/9789240025233

https://extranet.who.int/pqweb/vector-control-products
https://apps.who.int/iris/bitstream/handle/10665/255644/WHO-HTM-GMP-2017.13-eng.pdf
https://osp.od.nih.gov/wp-content/uploads/NExTRAC-Gene-Drives-Final-Report.pdf

Government regulation of gene drive-modified mosquitoes likely will involve more than one regulatory authority, and more than one type of permit for importation and research. In countries that are Parties to the Cartagena Protocol, genetically modified organisms must be reviewed through a biosafety mechanism established under the national biosafety law. It is expected that Ministries of Health and Ministries of Environment, and possibly others, will be involved. In the US, which is not a signatory to the Cartagena Protocol, genetically modified mosquitoes aimed at reducing population size (population suppression approaches) currently are regulated by the Environmental Protection Agency, while genetically modified mosquitoes that aim to reduce vectorial capacity (population modification) are regulated by the Food and Drug Administration.

For more information:

https://www.who.int/publications/i/item/9789240025233 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10102045/
https://bch.cbd.int/protocol/background/
https://www.cbd.int/doc/legal/cartagena-protocol-en.pdf
https://www.fda.gov/media/102158/download

Because mosquitoes are mobile and gene drive is meant to spread through interbreeding populations of the targeted species, transboundary issues are relevant for gene drive-modified mosquitoes. This has raised concerns about international governance. There are many multinational agreements that address transboundary movement. The general consensus of such international conventions is that prior to release into the environment there should be a notification and a bilateral or multilateral consultative process with countries to which the modified organism may move.

For gene drive-modified Anopheles gambiae mosquitoes being developed to prevent malaria transmission, the target species is restricted to the African continent. Under the leadership of the African Union Development Agency (AUDA-NEPAD) mechanisms to support regional harmonization of regulatory requirements for vector control methods in Africa, including gene drive-modified mosquitoes, are under development.

For more information:

https://www.who.int/publications/i/item/9789240025233
https://onlinelibrary.wiley.com/doi/full/10.1111/reel.12289
https://www.sciencedirect.com/science/article/pii/S1877343520300890
https://www.nepad.org/microsite/integrated-vector-management-ivm

A committee of the US National Academies of Science, Engineering and Medicine, an independent non-profit organization charged with providing objective advice to inform policy making, took a close look at this question. In a 2016 report, they defined three levels of stakeholders to engage in discussion: “communities” of people who live at or near the potential testing site; “stakeholders” who live elsewhere but have direct professional or personal interests in the use of the technology; and “publics” who lack any direct connection but whose opinions may inform democratic decision making. The WHO has recently defined a strategy for ethical engagement around testing of genetically modified, including gene drive modified, mosquitoes for public health. This strategy recognizes that the ethical obligations to each of these groups differ, and thus anticipated engagement requirements also will differ. Appropriate engagement activities also will differ for different phases of testing.

For more information:

https://nap.nationalacademies.org/catalog/23405/gene-drives-on-the-horizon-advancing-science-navigating-uncertainty-and
https://www.who.int/publications/i/item/9789240025233
https://www.youtube.com/watch?v=71VYXRoz_4k
https://genedrivenetwork.org/videos#mxYouTubeRca593b85386c88963051a7d9307938e5-4

The World Health Organization has recommended that the mechanism for community deliberation and authorization should be determined by the community itself according to its norms.

• Consent: Field testing of genetic biocontrol technologies are guided by the widely recognized informed consent goal of protecting the interests of those who will be affected by the research. According to international ethics standards, individual informed consent will be a pre-requisite when personally identifiable information or biological specimens will be collected in the course of trials. For other activities, some form of community-level permission should be obtained to proceed according to conditions negotiated during the engagement process. Testing plans will be overseen by an institutional or national ethics committee (or review board), whose role is to protect the rights and welfare of research participants.
• Co-development: Co-development and knowledge integration are increasingly recognized as critical to advancement of new products. Co-development is envisioned as a process including input from the community at the proposed field site, allowing opportunity for community members to ask questions and engage in dialog with researchers, and to make suggestions or express concerns.
• Risk assessment: Risk and/or impact assessments also are expected to include community concerns and socioeconomic risks, such as any potential negative impact on basic living conditions, social structure, public health, or livelihood.
• Regulatory: Public consultation is a requirement for approval of activities involving GMOs in most country legislation.

For more information:

https://www.who.int/news/item/08-10-2020-launch-of-ethics-vector-borne-diseases-who-guidance
https://www.who.int/publications/i/item/9789240025233

https://www.youtube.com/playlist?list=PLbopRNGowKJ9BGgg2BHu-VWYZgXpe0iLS
https://genedrivenetwork.org/videos#mxYouTubeRca593b85386c88963051a7d9307938e5-4

https://gatesopenresearch.org/articles/5-19/v2 

https://malariajournal.biomedcentral.com/articles/10.1186/s12936-022-04183-w

Surveys of attitudes in disease-endemic countries are underway. Early results suggest that people in disease endemic countries are open to the concept of genetically modified mosquitoes for public health but have concerns that will need to be addressed.

For more information:

https://allianceforscience.cornell.edu/10-things-everyone-should-know-about-gmos-in-africa/
https://www.acbio.org.za/what-does-synthetic-biology-mean-africa-africa-regional-briefing-publication-produced-etc-third
https://malariajournal.biomedcentral.com/articles/10.1186/1475-2875-9-128
https://malariajournal.biomedcentral.com/articles/10.1186/1475-2875-13-154
https://malariajournal.biomedcentral.com/articles/10.1186/s12936-019-2978-5
https://malariajournal.biomedcentral.com/articles/10.1186/s12936-020-03239-z

https://malariajournal.biomedcentral.com/articles/10.1186/s12936-021-03682-6