Gene Drive Regulatory Network

The FNIH and collaborators are supporting regulatory capacity strengthening activities in anticipation of the potential testing and use of gene drive products.

  • Problem Formulation for Testing and Use of Gene Drive Mosquitoes: In May 2016, the FNIH hosted a workshop with global scientific and regulatory experts to systematically evaluate the potential risks associated with the use of gene drive mosquitoes intended to reduce the burden of malaria in Africa. During the workshop, participants undertook a problem formulation exercise, focusing on gene drive mosquitoes as a method for control of the malaria vector Anopheles gambiae in Sub-Saharan Africa. Participants discussed how relevant protection goals and hazards may help to inform risk assessments of investigational gene drive organisms, the design of gene drive research and future guidelines and regulations on the use of the technology. The consensus points were published in The American Journal of Tropical Medicine and Hygiene.
  • Gene Drive Problem Formulation Consultations in Africa: The New Partnership for Africa’s Development (NEPAD), the implementing agency of the African Union, held workshops in Accra, Ghana (October 2016); Nairobi, Kenya (June 2017); Gaborone, Botswana (June 2017); and Libreville, Gabon (February 2018), bringing together representatives from regional biosafety and health regulatory authorities to discuss the concept of gene drive mosquitoes as a public health tool for reducing transmission of vector borne diseases. The FNIH provided facilitation support and attended the workshops. The participants were presented with background information on mosquito biology, ecology and role in malaria transmission, as well as technical information on genetic engineering and gene drive function. Informative precedents from biocontrol, genetically modified crops and medicines were reviewed. In addition, participants undertook an exercise in identifying potential hazards associated with this research, and in discussions on the applicability of regional harmonization in evaluating this technology. The outcomes from these workshops were published in The American Journal of Tropical Medicine and Hygiene.
  • Regulatory Workshops in Africa: The FNIH works with NEPAD and other collaborators to support efforts to enhance regulatory readiness for evaluating gene drive technology.

Contact

For more information, please contact GeneDrivePrograms@fnih.org.