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);