Biotechnology companies in Germany are disappointed about the decision by the European Court of Justice (ECJ) on the legal classification of molecular-biological methods ++ General widening of the scope of the European GMO Directive blocks the enormous innovation potential of genome editing for agriculture and also for medicine and bio-based chemicals.
Biotechnology companies in Germany are disappointed at the decision by the European Court of Justice (ECJ) on the legal classification of molecular-biological methods called genome editing. The judges hold that all uses of genome editing result in genetically modified organisms (GMOs) – also where their genetic material cannot be distinguished from natural variants or the outcomes of conventional breeding. From the perspective of the German association of biotechnology industries Deutsche Industrievereinigung Biotechnologie (DIB), this general widening of the scope of the European GMO Directive blocks the enormous innovation potential of genome editing for agriculture and also for medicine and bio-based chemicals.
DIB executive director Ricardo Gent states: “The ECJ judgment is very bad news for plant breeders, medical researchers and producers of bio-based chemicals. Highly innovative methods such as Crispr/Cas are overregulated without any scientific justification.” The association DIB does not share the Court’s view that modern mutagenesis methods, such as genome editing, involve potential risks comparable to those of older transgenesis techniques (introduction of foreign DNA into an organism). Should politicians restrict the use of genome editing on this basis, Germany and Europe would fall behind countries like China and the USA in all areas of biotechnology, so Gent.
The DIB executive director emphasizes: “Today, genome editing provides the molecular-biological tools that open up great opportunities in research and development for novel therapies and new crop varieties or in industrial biotechnology. A decision against these tools will adversely affect the innovation ability and the competitiveness of companies.”
The association cannot understand the logic behind the ECJ judgment. In legal terms, previously a GMO was given only if the genetic material of crops or bacteria was altered in a way that would not have been possible naturally. Now, genome editing enables a modification of genetic material that is similar to a mutation through natural change.
Gent explains: “Genome editing can lead to genetically modified organisms but this is not necessarily the case. Independent scientific authorities, such as the German Federal Office of Consumer Protection and Food Safety (BVL), the Federal Institute for Risk Assessment (BfR) and the Central Committee on Biological Safety (ZKBS), see it this way too. We would have very much liked the judges to base their decision on scientific findings.”