Camila Beech, Senior Regulatory Advisor to Target Malaria

Silke Fuchs, Regulatory Science Officer at Target Malaria

It has recently been reported that Germany is implementing changes to its genetic engineering laws. Under the new rules, gene drive organisms developed and used in laboratory settings, also known as “contained use”, may be subject to the highest biological safety categories. 

With changes to the Genetic Engineering Safety Ordinance (GenTSV) coming into force on March 1, 2021, gene drive organisms (GDO) are explicitly included in the scope of German genetic engineering law. This builds on an amendment from 2019 when a procedure for determining safety requirements for laboratory experiments with gene drive organisms was established.  The GenTSV ordinance assesses the risk potential of the donor and recipient organism as well as the resulting genetically modified organism, using a pre-established system that assigns organisms to four risk groups (1 to 4). These biosafety levels are used for microorganisms, plants and animals, and genetic technologies used for the production of toxins. The ordinance also refers to genetic technologies with animals, such as mosquitoes and plants that bias their inheritance, i.e. gene drives. Specifically, it states that (translated from the German original);

Gene drive technologies can potentially control disease vectors and pest species. However, before gene drive organisms are released into the environment, scientists need to ensure they are effective and safe. They need, for example, to make sure that gene drive impact is restricted to the species they aim to control, avoiding the spread of the gene to non-target species.

The paper “Double drives and private alleles for localised population genetic control” recently published in Plos Genetics explores how to limit gene drive impact to target populations. It proposes a series of low threshold double drive designs for population suppression. Each of them consists of two constructs: one imposing a reproductive load on the population, and the other inserted into a differentiated locus and controlling the drive of the first.

The Ifakara Health Institute will host the webinar “There is a gene in my mosquitoes” on March 24 as part of its MasterClasses initiative. Prof Austin Burt (Imperial College London, UK), Dr Tony Nolan (Liverpool School of Tropical Medicine, UK), and Prof Abdoulaye Diabate (Research Institute of Health Sciences - IRSS, Burkina Faso) will discuss what makes gene drives attractive for malaria control & elimination, pathways for testing and deployment of gene drive mosquitoes, limitations & challenges of gene drive technologies and much more!

If you would like to attend, please register in advance here.

The journal Health Security will publish a special edition on gene drive governance in the US. The journal is calling for papers exploring policy, practice, and research issues relevant to the topic, as well as reviews of specific US policies related to gene drives and emergent biotechnologies. The deadline for submissions is May 31.

Scientists at the University of California, San Diego (UCSD) have engineered a new gene drive that allows for a higher degree of control and minimizes the risk of genetic changes that could lead to unintended ecological consequences.

The “split drive” system allows genetic parameters and strategies to either limit or extend the gene drive potential. According to Dr. Ethan Bier, senior author of the study, this tailored approach to gene drives could potentially enable the control of insect vectors and pests in diverse contexts.