Issues in Regulatory Science for Gene Drive-Modified Insects
On December 4 and 5, 2019, FNIH hosted a workshop aimed to provide a deliberative space for international experts in regulatory science and risk assessment to consider whether gene drive products would present any new issues that are not addressed by regulatory frameworks and procedures currently used to assess regulated insects or regulated insect control products.
Some of the aspects discussed at the workshop included, implications of product design and potential uses, implications of spread and persistence in the environment, data that maybe required in regulatory submissions for contained use and field release, and safety criteria for moving from contained use to initial release. There was overall agreement on several key points such as involving all relevant regulatory authorities efficiently and early in the process, evaluation should be case-by-case with the transformed insect being the regulated product, developers should have a clear goal for their product such as pest control or health benefits, risk assessment and data requirements would differ based on the type of gene drive and the strategy- population suppression versus population modification, developers should be ready to provide risk management plans, modeling would be an important tool for addressing gaps, and experience from other regulated products such as biocontrol agents and sterile insect technologies could assist with general expectations of data types and application form questions.
Participants agreed on the value of deliberating these issues among experts and recommended revisiting regulatory application forms for GM organisms with the goal of working towards generating a consensus application form specifically for GM insects for further consideration in a subsequent meeting.
Regulatory Consultative Workshops
Working with the African Union Development Agency (AUDA-NEPAD), GeneConvene has provided technical support for regional consultative workshops for regulatory authorities that are designed to build awareness of gene drive technologies.
Three workshops have been held to-date: 1) 16-18 October 2018 in Dakar, Senegal; 2) 4-6 March 2019 in Entebbe, Uganda; and 3) 6-8 August 2019, in Maputo, Mozambique.
Gene Editing Technologies and Their Application in the Life Sciences and Medicine in Africa
The FNIH held a mini-course on gene editing technologies in June 2019 at the International Centre for Insect Physiology and Ecology (ICIPE) in Nairobi, Kenya. This course, co-sponsored by ICIPE and TReND in Africa, provided an opportunity for established researchers and academics to extend their professional expertise by obtaining a rigorous understanding of gene editing technologies and their underlying mechanisms.
Notable applications of these technologies with direct relevance to Africa, such as malaria eradication, crop improvement and gene therapy, were studied. This course was the first in a series to be offered over the next four years that are intended to strengthen the capacity of African scientists to participate in discussions regarding the use of contemporary genetic technologies to address challenges to the health and welfare of Africans.
Second African Biosafety Leadership Summit: Gene Drive Technology as a Potential Biocontrol Tool for Vector-borne Diseases in Sub-Saharan Africa and Relevant Issues to be Discussed at COP-MOP
In 2018, the FNIH supported a meeting hosted by the National Biosafety Authority, Kenya that brought together biosafety and health regulators, policy makers and other professionals to share experiences, to analyze the key capacity building needs, to share existing country laws and past experience on regulation of vector control or GM mosquitoes.
These discussions considered how existing frameworks may be applied to research and deployment of gene drive technologies in Africa, and opportunities for developing consensus regulatory and institutional frameworks for regulating gene drive and synthetic biology in countries and in the African region.
Talking About Gene Drive: Communications Workshop
The FNIH organized a one-day workshop in November 2017 in Baltimore, MD, attended by more than 70 researchers conducting or interested in gene drive research for public health, conservation and agriculture applications.
The workshop was designed to create an opportunity for participants to think collectively about how to discuss gene drive technology productively with the public.
Roundtable Discussion, Malaria Control in Africa through Genetic Modification of Malaria Vectors
On October 11, 2016, the African Academy of Sciences and the FNIH co-hosted a roundtable discussion in Nairobi, Kenya, on the use of gene drive technology for malaria control. A group of about 20 scientists from across Africa with expertise in infectious diseases, entomology and public health participated in the meeting.
Discussions focused on approaches to decrease the number of malaria-carrying mosquitoes in Africa. Meeting participants raised questions on safety and efficacy aspects of the technology. Participants also noted the importance of initiating engagement activities with various diverse groups of stakeholders early in the research and development process. Given the potential for transboundary movement of gene drive-modified mosquitoes, all participants agreed that early engagement at the regional level should be a priority. Finally, participants discussed the opportunities and challenges that new technologies, such as gene drive, create for African scientists and institutions. Technology transfer and capacity strengthening (scientific and regulatory) were seen as essential to ensure successful development, testing, and, if appropriate, implementation of gene drive products, and African leadership in these activities was emphasized as critical.