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Guidelines for Importation, Exportation, Handling, Labelling and Storage of Genetically Modified Mosquitoes

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Guidelines for Importation, Exportation, Handling, Labelling and Storage of Genetically Modified Mosquitoes

Approximately 80% of the world’s population is at risk of one or more vector-borne diseases (VBDs), which together are responsible for 17% of the global burden of diseases. Considering the significance of these diseases, the Economic Community of West African States (ECOWAS) has agreed on the establishment of a West Africa- Integrated Vector Management (WA-IVM) Programme. The purpose of this Programme is to establish and operationalise a platform for the region to build strong collaborations among member countries on issues relevant to effective control of the vectors. Some of the key elements being considered include biosafety, environment, ethics, regulatory oversight, and health systems, among others. The WA-IVM platform also aims to equip and capacitate the region with innovative technologies and novel approaches for controlling the arthropod vectors. Considering that malaria is the most important vector-borne disease in sub-Saharan Africa, the WA-IVM Programme will use malaria as a pathfinder disease for developing its platform activities.

The emergence of gene drive technologies holds prospects for future deployment to significantly improve control and accelerate efforts towards the elimination of malaria. Current approaches can be used to either suppress malaria vector populations or to alter them such that they no longer transmit malaria. Due to the biased inheritance of traits, gene drive modified mosquitoes spread faster than the limits imposed by Mendelian inheritance. There are, however, still many unknowns regarding the safety and field-efficacy of these technologies; thus, further evaluation is necessary for both laboratory and real-field settings. Recent mathematical simulations in West Africa indicated considerable suppression of vector populations could be achieved within a few years of using a female sterility gene drive, though the impact is likely to be heterogeneous in space and time. It was observed that using a CRISPR-Cas9 gene drive to reduce female fertility could result in a 95% decrease in the relevant mosquito population on a regional scale after 4 years of deployment. The actual spread in the wild will likely be patchy and slow, but most available evidence suggests that these gene drives will be highly impactful against malaria even if they themselves are not a silver bullet and are only used to complement existing interventions. Due to the flight nature of mosquitoes, modified mosquitoes could have negative or positive transboundary impacts depending on the expression of the traits they carry. There are, therefore, regional regulatory implications in their deployment.

As part of the WA-IVM initiative, a number of guidelines have been created to provide an improved protocol for the prevention of biosafety risks while ensuring beneficial and sustainable applications of gene drive technology. These guidelines refer to multiple processes but also anticipate the potential transboundary movement of gene drive modified mosquitoes (GDMs) and how to address any adverse effects. The guidelines will advance consultations, ethical applications, and sustainable use of GDMs. This specific guideline focuses on procedures around the intentional movement of GDMs, and therefore covers importation, exportation, transfer, labelling, and storage processes.