Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission

Abstract

Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs have yet undergone field testing. This early stage is an opportune time for developers, supporters, and possible users to begin to consider the potential regulatory requirements for eventual implementation of these technologies in national or regional public health programs, especially as some of the practical implications of these requirements may take considerable planning, time and coordination to address. Several currently unresolved regulatory questions pertinent to the implementation of GDMMs are examined, including: how the product will be defined; what the registration/approval process will be for placing new GDMM products on the market; how the potential for transboundary movement of GDMMs can be addressed; and what role might be played by existing multinational bodies and agreements in authorization decisions. Regulation and policies applied for registration of other genetically modified organisms or other living mosquito products are assessed for relevance to the use case of GDMMs to prevent malaria in Africa. Multiple national authorities are likely to be involved in decision-making, according to existing laws in place within each country for certain product classes. Requirements under the Cartagena Protocol on Biodiversity will be considered relevant in most countries, as may existing regulatory frameworks for conventional pesticide, medical, and biocontrol products. Experience suggests that standard regulatory processes, evidence requirements, and liability laws differ from country to country. Regional mechanisms will be useful to address some of the important challenges.

The behaviour of adult Anopheles gambiae, sub-Saharan Africa’s principal malaria vector, and its relevance to malaria control: a review

“…With a rapid increase in electric lighting in parts of rural Africa it is important to understand how this may affect mosquito house entry and trapping with light traps. Behavioural barriers to gene flow To help accelerate the deployment of gene drive mosquitoes in the field [ 193 ] it is important to understand the barriers to mating that occur in wild populations of mosquitoes and between laboratory-reared and wild mosquitoes. Whilst scientists may anticipate rapid spread of genes through a population of wild mosquitoes there are likely to be many natural behavioural barriers that restrict or prevent gene flow.…”

“…To help accelerate the deployment of gene drive mosquitoes in the field [ 193 ] it is important to understand the barriers to mating that occur in wild populations of mosquitoes and between laboratory-reared and wild mosquitoes. Whilst scientists may anticipate rapid spread of genes through a population of wild mosquitoes there are likely to be many natural behavioural barriers that restrict or prevent gene flow.…”

The Perpetual Vector Mosquito Threat and Its Eco-Friendly Nemeses

“…More current cage studies have been described, and the results lend support to the efficacy of this emerging technology in controlling vector mosquito populations [ 201 , 202 , 203 , 204 , 205 ]. In addition, commentaries on the prospect of eradicating malaria using CRISPR/Cas9 gene drive [ 206 , 207 ] and regulatory and policy considerations [ 208 ] are the subjects of scrutiny and debate.…”

Regulations of malaria in children with human immunodeficiency virus infection: A review

“…This is because some of the practical implications of these requirements may require significant planning, time, and integration to address. [32]…”