Gene drive technologies and global health: a bioethical framework for vector control in contexts of inequality
DOI:
https://doi.org/10.15343/0104-7809.202650e19042025PKeywords:
Gene Drive, Epistemic Sovereignty, Vector-borne Diseases, Precautionary Principle, Distributive JusticeAbstract
Vector-borne diseases remain a major global health burden, with dengue reaching 14.6 million cases and malaria causing nearly 600,000 deaths in 2024, disproportionately affecting populations in the Global South. Gene drive technologies based on CRISPR-Cas9 have emerged as a disruptive approach to vector control, yet their governance is marked by regulatory and epistemic asymmetries. This study aims to formulate an integrative bioethical framework from which operational criteria can be derived for regulating gene drive technologies in contexts of epidemiological urgency. A theoretical-normative methodology was applied, integrating epidemiological evidence with critical bioethics, decolonial epistemology, and international biosafety law. The analysis develops a framework that combines responsibility ethics with epistemic sovereignty, from which a matrix of distributive justice indicators and community consultation protocols is derived for regulatory application in the Global South. The findings indicate that existing regulatory instruments, particularly the Cartagena Protocol, present limitations in addressing irreversibility, transboundary risks, and liability. The proposed framework provides a structured approach to incorporate precaution, justice, and procedural legitimacy into decision-making processes. These results suggest that effective governance of gene drive technologies requires integrating scientific assessment with socially grounded criteria, contributing to more robust and context-sensitive regulatory practices in global health.
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This article is a translation in Português (Brasil) of the article:
Gene drive technologies and global health: a bioethical framework for vector control in contexts of inequality
References
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Ogoyi DO, Njagi J, Tonui W, Dass B, Quemada H, James S. Post-release monitoring pathway for the deployment of gene drive-modified mosquitoes for malaria control in Africa. Malar J [Internet]. 2024 [accessed April 13, 2026]; 23(351): 1–17. Available at: https://doi.org/10.1186/s12936-024-05179-4
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Schmidt H, Collier TC, Hanemaaijer MJ, Houston PD, Lee Y, Lanzaro GC. Abundance of conserved CRISPR-Cas9 target sites within the highly polymorphic genomes of Anopheles and Aedes mosquitoes. Nat Commun [Internet]. 2020 [accessed April 13, 2026]; 11(1425): 1–6. Available at: https://doi.org/10.1038/ s41467-020-15204-0
Oye KA, Esvelt K, Appleton E, Catteruccia F, Church G, Kuiken T, et al. Regulating gene drives. Science [Internet]. 2014 [accessed April 13, 2026]; 345(6197): 626–628. Available at: https://doi.org/10.1126/science.1254287
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Finda MF, Sambo M, Malika G, Njalambaha R, Salum S, Okumu FO. Exploratory conversations with biodiversity-oriented civil society groups on the potential applications of gene drive-modified mosquitoes for malaria control in Tanzania. Transgenic Res [Internet]. 2026 [accessed April 13, 2026]; 35(1): 1–18. Available at: https://doi.org/10.1007/s11248-025-00476-3
Kormos A, Lanzaro GC, Bier E, Santos V, Nazaré L, Pinto J, et al. Ethical considerations for gene drive: challenges of balancing inclusion, power and perspectives. Front Bioeng Biotechnol [Internet]. 2022 [accessed April 13, 2026]; 10: 826727. Available at: https://doi.org/10.3389/fbioe.2022.826727
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de Sousa Santos B. Epistemologies of the South: justice against epistemicide. Boulder: Paradigm Publishers; 2014.
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Corrêa-Antônio J, David MR, Couto-Lima D, Garcia GA, Keirsebelik MSG, Maciel-de-Freitas R, et al. DENV-1 titer impacts viral blocking in twMel Aedes aegypti with Brazilian genetic background. Viruses [Internet]. 2024 [accessed April 13, 2026]; 16(2): 214. Available at: https://doi.org/10.3390/v16020214
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Kuzma J. Procedurally robust risk assessment framework for novel genetically engineered organisms and gene drives. Regul Gov [Internet]. 2021 [accessed April 13, 2026]; 15(4): 1144–1165. Available at: https://doi.org/10.1111/rego.12245
Meghani Z, Kuzma J. Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito. J Responsible Innov [Internet]. 2018 [accessed April 13, 2026]; 5(Suppl 1): S203–S222. Available at: https://doi.org/10.1080/23299460.2017.1407912
Glover B, Akinbo O, Savadogo M, Timpo S, Lemgo G, Sinebo W, et al. Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD’s experience in establishing regulatory systems for medicines and GM crops in Africa. BMC Proc [Internet]. 2018 [accessed April 13, 2026]; 12(Suppl 8): 11. Available at: https://doi.org/10.1186/s12919-018-0108-y
Kelsey A, Stillinger D, Pham TB, Murphy J, Firth S, Carballar-Lejarazú R. Global governing bodies: a pathway for gene drive governance for vector mosquito control. Am J Trop Med Hyg [Internet]. 2020 [accessed April 13, 2026]; 103(3): 976–985. Available at: https://doi.org/10.4269/ajtmh.19-0941
Quijano A. Cuestiones y horizontes: de la dependencia histórico-estructural a la colonialidad/descolonialidad del poder. Antología esencial. Clímaco DA, editor. Buenos Aires: CLACSO; 2014.
Feo Istúriz O, Basile G, Maizlish N. Rethinking and decolonizing theories, policies, and practice of health from the Global South. Int J Soc Determinants Health Health Serv [Internet]. 2023 [accessed April 13, 2026]; 54(1): 1–11. Available at: https://doi.org/10.1177/27551938231199325
Pogge TW. World poverty and human rights: cosmopolitan responsibilities and reforms. Cambridge: Polity Press; 2002.
Fricker M. Epistemic injustice: power and the ethics of knowing. Oxford: Oxford University Press; 2007.
Pratt B, de Vries J. Where is knowledge from the Global South? An account of epistemic justice for a global bioethics. J Med Ethics [Internet]. 2023 [accessed April 13, 2026]; 49(10): 663–670. Available at: https://doi.org/10.1136/jme-2022-108291
Secretaría del Convenio sobre la Diversidad Biológica. Protocolo de Cartagena sobre seguridad de la biotecnología del Convenio sobre la Diversidad Biológica: texto y anexos. Montreal: Secretaría del Convenio sobre la Diversidad Biológica; 2000.
Jonas H. The imperative of responsibility: in search of an ethics for the technological age. Chicago: University of Chicago Press; 1985.
Boersma K, Ludwig D, Bovenkerk B. Gene drives as interventions into nature: the coproduction of ontology and morality in the gene drive debate. Nanoethics [Internet]. 2023 [accessed April 13, 2026]; 17(4): 1–15. Available at: https://doi.org/10.1007/s11569-023-00439-0
Annas GJ, Beisel CL, Clement K, Crisanti A, Francis S, Galardini M, et al. A code of ethics for gene drive research. CRISPR J [Internet]. 2021 [accessed April 13, 2026]; 4(1): 19–26. Available at: https://doi.org/10.1089/crispr.2020.0096
Benatar S, Daibes I, Tomsons S. Inter-philosophies dialogue: creating a paradigm for global health ethics. Kennedy Inst Ethics J [Internet]. 2016 [accessed April 13, 2026]; 26(3): 323–346. Available at: https://doi.org/10.1353/ken.2016.0027
Biswas I. Ethical dimensions and societal implications: ensuring the social responsibility of CRISPR technology. Front Genome Ed [Internet]. 2025 [accessed April 13, 2026]; 7: 1593172. Available at: https://doi.org/10.3389/fgeed.2025.1593172
Sykes N, Bigirwenkya J, Coche I, Drabo M, Dzokoto D, O’Loughlin S, et al. Procedural legitimacy: co-developing a community agreement model for genetic approaches research to malaria control in Africa. Malar J [Internet]. 2024 [accessed April 13, 2026]; 23(359): 1–15. Available at: https://doi.org/10.1186/s12936 024-05160-1
Wise IJ, Borry P. An ethical overview of the CRISPR-based elimination of Anopheles gambiae to combat malaria. J Bioeth Inq [Internet]. 2022 [accessed April 13, 2026]; 19(4): 641–656. Available at: https://doi.org/10.1007/s11673-022-10172-0
Pare Toe L, Dicko B, Linga R, Barry N, Drabo M, Sykes N, et al. Operationalizing stakeholder engagement for gene drive research in malaria elimination in Africa—translating guidance into practice. Malar J [Internet]. 2022 [accessed April 13, 2026]; 21(225): 1–16. Available at: https://doi.org/10.1186/s12936-022 04241-3
Pare Toe L, Barry N, Ky AD, Kekele S, Meda W, Bayala K, et al. Small-scale release of non-gene drive mosquitoes in Burkina Faso: from engagement implementation to assessment, a learning journey. Malar J [Internet]. 2021 [accessed April 13, 2026]; 20(395): 1–16. Available at: https://doi.org/10.1186/ s12936-021-03929-2
James S, Collins FH, Welkhoff PA, Emerson C, Godfray HCJ, Gottlieb M, et al. Pathway to deployment of gene drive mosquitoes as a potential biocontrol tool for elimination of malaria in sub-Saharan Africa: recommendations of a scientific working group. Am J Trop Med Hyg [Internet]. 2018 [accessed April 13, 2026]; 98(Suppl 6): 1–49. Available at: https://doi.org/10.4269/ajtmh.18-0083
Sansone NMS, Boschiero MN, Marson FAL. Dengue outbreaks in Brazil and Latin America: the new and continuing challenges. Int J Infect Dis [Internet]. 2024 [accessed April 13, 2026]; 147: 107192. Available at: https://doi.org/10.1016/j.ijid.2024.107192
Gurgel-Gonçalves R, de Oliveira WK, Croda J. The greatest dengue epidemic in Brazil: surveillance, prevention, and control. Rev Soc Bras Med Trop [Internet]. 2024 [accessed April 13, 2026]; 57: e00203-2024. Available at: https://doi.org/10.1590/0037-8682-0113-2024
Ogoyi DO, Njagi J, Tonui W, Dass B, Quemada H, James S. Post-release monitoring pathway for the deployment of gene drive-modified mosquitoes for malaria control in Africa. Malar J [Internet]. 2024 [accessed April 13, 2026]; 23(351): 1–17. Available at: https://doi.org/10.1186/s12936-024-05179-4
Hammond A, Galizi R, Kyrou K, Simoni A, Siniscalchi C, Katsanos D, et al. A CRISPR-Cas9 gene drive system targeting female reproduction in the malaria mosquito vector Anopheles gambiae. Nat Biotechnol [Internet]. 2016 [accessed April 13, 2026]; 34(1): 78–83. Available at: https://doi.org/10.1038/nbt.3439
Schmidt H, Collier TC, Hanemaaijer MJ, Houston PD, Lee Y, Lanzaro GC. Abundance of conserved CRISPR-Cas9 target sites within the highly polymorphic genomes of Anopheles and Aedes mosquitoes. Nat Commun [Internet]. 2020 [accessed April 13, 2026]; 11(1425): 1–6. Available at: https://doi.org/10.1038/ s41467-020-15204-0
Oye KA, Esvelt K, Appleton E, Catteruccia F, Church G, Kuiken T, et al. Regulating gene drives. Science [Internet]. 2014 [accessed April 13, 2026]; 345(6197): 626–628. Available at: https://doi.org/10.1126/science.1254287
National Academies of Sciences, Engineering, and Medicine. Gene drives on the horizon: advancing science, navigating uncertainty, and aligning research with public values. Washington, DC: The National Academies Press; 2016.
Finda MF, Sambo M, Malika G, Njalambaha R, Salum S, Okumu FO. Exploratory conversations with biodiversity-oriented civil society groups on the potential applications of gene drive-modified mosquitoes for malaria control in Tanzania. Transgenic Res [Internet]. 2026 [accessed April 13, 2026]; 35(1): 1–18. Available at: https://doi.org/10.1007/s11248-025-00476-3
Kormos A, Lanzaro GC, Bier E, Santos V, Nazaré L, Pinto J, et al. Ethical considerations for gene drive: challenges of balancing inclusion, power and perspectives. Front Bioeng Biotechnol [Internet]. 2022 [accessed April 13, 2026]; 10: 826727. Available at: https://doi.org/10.3389/fbioe.2022.826727
Quijano A. Colonialidad del poder, eurocentrismo y América Latina. In: Lander E, editor. La colonialidad del saber: eurocentrismo y ciencias sociales. Perspectivas latinoamericanas. Buenos Aires: CLACSO; 2000. p. 201–246.
de Sousa Santos B. Epistemologies of the South: justice against epistemicide. Boulder: Paradigm Publishers; 2014.
Oehring D, Gunasekera P. Ethical frameworks and global health: a narrative review of the “leave no one behind” principle. Inquiry [Internet]. 2024 [accessed April 13, 2026]; 61: 1–13. Available at: https://doi.org/10.1177/00469580241288346
Ogunlade ST, Adekunle AI, McBryde ES. Mitigating dengue transmission in Africa: the need for Wolbachia-infected mosquitoes rollout. Front Public Health [Internet]. 2024 [accessed April 13, 2026]; 12: 1506072. Available at: https://doi.org/10.3389/fpubh.2024.1506072
Moretti R, Lim JT, Ferreira AGA, Ponti L, Giovanetti M, Yi CJ, et al. Exploiting Wolbachia as a tool for mosquito-borne disease control: pursuing efficacy, safety, and sustainability. Pathogens [Internet]. 2025 [accessed April 13, 2026]; 14(3): 285. Available at: https://doi.org/10.3390/pathogens14030285
Bocanegra-Villegas LV, Usaquen-Perilla SP, Gómez-Figueroa MA. Impact of Wolbachia-containing mosquito release on dengue control: a systems dynamics approach for health policy development. Global Health J [Internet]. 2025 [accessed April 13, 2026]; 9: 314–322. Available at: https://doi.org/10.1016/j. glohj.2025.11.003
Ross PA, Robinson KL, Yang Q, Callahan AG, Schmidt TL, Axford JK, et al. A decade of stability for wMel Wolbachia in natural Aedes aegypti populations. PLoS Pathog [Internet]. 2022 [accessed April 13, 2026]; 18(2): e1010256. Available at: https://doi.org/10.1371/journal.ppat.1010256
Anders KL, Ribeiro GS, Lopes RS, Amadeu P, da Costa TR, Riback TIS, et al. Long-term durability and public health impact of city-wide wMel Wolbachia mosquito releases in Niterói, Brazil, during a dengue epidemic surge. Trop Med Infect Dis [Internet]. 2025 [accessed April 13, 2026]; 10(9): 237. Available at: https://doi.org/10.3390/tropicalmed10090237
Ribeiro dos Santos G, Durovni B, Saraceni V, Riback TIS, Pinto SB, Anders KL, et al. Estimating the effect of the wMel release programme on the incidence of dengue and chikungunya in Rio de Janeiro, Brazil: a spatiotemporal modelling study. Lancet Infect Dis [Internet]. 2022 [accessed April 13, 2026]; 22(11): 1587–1595. Available at: https://doi.org/10.1016/S1473-3099(22)00436-4
Calle-Tobón A, Rojo-Ospina R, Zuluaga S, Giraldo-Muñoz JF, Cadavid JM. Evaluation of Wolbachia infection in Aedes aegypti suggests low prevalence and highly heterogeneous distribution in Medellín, Colombia. Acta Trop [Internet]. 2024 [accessed April 13, 2026]; 260: 107423. Available at: https://doi. org/10.1016/j.actatropica.2024.107423
Corrêa-Antônio J, David MR, Couto-Lima D, Garcia GA, Keirsebelik MSG, Maciel-de-Freitas R, et al. DENV-1 titer impacts viral blocking in twMel Aedes aegypti with Brazilian genetic background. Viruses [Internet]. 2024 [accessed April 13, 2026]; 16(2): 214. Available at: https://doi.org/10.3390/v16020214
Pavan MG, Gnonhoue FJ, Corrêa-Antônio J, Padilha KP, Garcia GA, de Oliveira F, et al. The long-term persistence of the wMel strain in Rio de Janeiro is threatened by poor integrated vector management and bacterium fitness cost on Aedes aegypti. PLoS Negl Trop Dis [Internet]. 2025 [accessed April 13, 2026]; 19(7): e0013372. Available at: https://doi.org/10.1371/journal.pntd.0013372
Gnankine O, Dabire RK. Natural occurrence of Wolbachia in Anopheles sp. and Aedes aegypti populations could compromise the success of vector control strategies. Front Trop Dis [Internet]. 2024 [accessed April 13, 2026]; 5: 1329015. Available at: https://doi.org/10.3389/fitd.2024.1329015
James SL, Dass B, Quemada H. Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission. Transgenic Res [Internet]. 2023 [accessed April 13, 2026]; 32. Available at: https://doi.org/10.1007/s11248-023-00335-z
Kuzma J. Procedurally robust risk assessment framework for novel genetically engineered organisms and gene drives. Regul Gov [Internet]. 2021 [accessed April 13, 2026]; 15(4): 1144–1165. Available at: https://doi.org/10.1111/rego.12245
Meghani Z, Kuzma J. Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito. J Responsible Innov [Internet]. 2018 [accessed April 13, 2026]; 5(Suppl 1): S203–S222. Available at: https://doi.org/10.1080/23299460.2017.1407912
Glover B, Akinbo O, Savadogo M, Timpo S, Lemgo G, Sinebo W, et al. Strengthening regulatory capacity for gene drives in Africa: leveraging NEPAD’s experience in establishing regulatory systems for medicines and GM crops in Africa. BMC Proc [Internet]. 2018 [accessed April 13, 2026]; 12(Suppl 8): 11. Available at: https://doi.org/10.1186/s12919-018-0108-y
Kelsey A, Stillinger D, Pham TB, Murphy J, Firth S, Carballar-Lejarazú R. Global governing bodies: a pathway for gene drive governance for vector mosquito control. Am J Trop Med Hyg [Internet]. 2020 [accessed April 13, 2026]; 103(3): 976–985. Available at: https://doi.org/10.4269/ajtmh.19-0941
Quijano A. Cuestiones y horizontes: de la dependencia histórico-estructural a la colonialidad/descolonialidad del poder. Antología esencial. Clímaco DA, editor. Buenos Aires: CLACSO; 2014.
Feo Istúriz O, Basile G, Maizlish N. Rethinking and decolonizing theories, policies, and practice of health from the Global South. Int J Soc Determinants Health Health Serv [Internet]. 2023 [accessed April 13, 2026]; 54(1): 1–11. Available at: https://doi.org/10.1177/27551938231199325
Pogge TW. World poverty and human rights: cosmopolitan responsibilities and reforms. Cambridge: Polity Press; 2002.
Fricker M. Epistemic injustice: power and the ethics of knowing. Oxford: Oxford University Press; 2007.
Pratt B, de Vries J. Where is knowledge from the Global South? An account of epistemic justice for a global bioethics. J Med Ethics [Internet]. 2023 [accessed April 13, 2026]; 49(10): 663–670. Available at: https://doi.org/10.1136/jme-2022-108291
Secretaría del Convenio sobre la Diversidad Biológica. Protocolo de Cartagena sobre seguridad de la biotecnología del Convenio sobre la Diversidad Biológica: texto y anexos. Montreal: Secretaría del Convenio sobre la Diversidad Biológica; 2000.
Jonas H. The imperative of responsibility: in search of an ethics for the technological age. Chicago: University of Chicago Press; 1985.
Boersma K, Ludwig D, Bovenkerk B. Gene drives as interventions into nature: the coproduction of ontology and morality in the gene drive debate. Nanoethics [Internet]. 2023 [accessed April 13, 2026]; 17(4): 1–15. Available at: https://doi.org/10.1007/s11569-023-00439-0
Annas GJ, Beisel CL, Clement K, Crisanti A, Francis S, Galardini M, et al. A code of ethics for gene drive research. CRISPR J [Internet]. 2021 [accessed April 13, 2026]; 4(1): 19–26. Available at: https://doi.org/10.1089/crispr.2020.0096
Benatar S, Daibes I, Tomsons S. Inter-philosophies dialogue: creating a paradigm for global health ethics. Kennedy Inst Ethics J [Internet]. 2016 [accessed April 13, 2026]; 26(3): 323–346. Available at: https://doi.org/10.1353/ken.2016.0027
Biswas I. Ethical dimensions and societal implications: ensuring the social responsibility of CRISPR technology. Front Genome Ed [Internet]. 2025 [accessed April 13, 2026]; 7: 1593172. Available at: https://doi.org/10.3389/fgeed.2025.1593172
Sykes N, Bigirwenkya J, Coche I, Drabo M, Dzokoto D, O’Loughlin S, et al. Procedural legitimacy: co-developing a community agreement model for genetic approaches research to malaria control in Africa. Malar J [Internet]. 2024 [accessed April 13, 2026]; 23(359): 1–15. Available at: https://doi.org/10.1186/s12936 024-05160-1
Wise IJ, Borry P. An ethical overview of the CRISPR-based elimination of Anopheles gambiae to combat malaria. J Bioeth Inq [Internet]. 2022 [accessed April 13, 2026]; 19(4): 641–656. Available at: https://doi.org/10.1007/s11673-022-10172-0
Pare Toe L, Dicko B, Linga R, Barry N, Drabo M, Sykes N, et al. Operationalizing stakeholder engagement for gene drive research in malaria elimination in Africa—translating guidance into practice. Malar J [Internet]. 2022 [accessed April 13, 2026]; 21(225): 1–16. Available at: https://doi.org/10.1186/s12936-022 04241-3
Pare Toe L, Barry N, Ky AD, Kekele S, Meda W, Bayala K, et al. Small-scale release of non-gene drive mosquitoes in Burkina Faso: from engagement implementation to assessment, a learning journey. Malar J [Internet]. 2021 [accessed April 13, 2026]; 20(395): 1–16. Available at: https://doi.org/10.1186/ s12936-021-03929-2
James S, Collins FH, Welkhoff PA, Emerson C, Godfray HCJ, Gottlieb M, et al. Pathway to deployment of gene drive mosquitoes as a potential biocontrol tool for elimination of malaria in sub-Saharan Africa: recommendations of a scientific working group. Am J Trop Med Hyg [Internet]. 2018 [accessed April 13, 2026]; 98(Suppl 6): 1–49. Available at: https://doi.org/10.4269/ajtmh.18-0083
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2026-05-12
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Ramos-Zaga, F. A. (2026). Gene drive technologies and global health: a bioethical framework for vector control in contexts of inequality. O Mundo Da Saúde, 50. https://doi.org/10.15343/0104-7809.202650e19042025P
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