Do We Need a New Definition of Genetic Engineering? Scientific, Ethical and Legal Perspectives on Regulating Genome-Edited Plants

New molecular biological technologies, which are summarised under the term of genome editing or genome surgery, have considerably changed the entire field of basic research in molecular biology, as well as biotechnology and biomedicine. The techniques allow very precise and controlled replacements and deletions of individual DNA building blocks and even complete gene sequences and are already widely used in plant cultivation. As a result, it is usually no longer possible to determine whether a genomic change is the result of a natural mutation, a conventional breeding method or a molecular intervention. For the German Genetic Engineering Act, however, the possibility of distinguishing between “natural” changes and those obtained by “non-natural” means constitutes a key element.

The advancement of molecular genetic methods has led to the blurring of differentiability and thus triggered an extremely controversial debate about what actually counts as a “genetically modified organism” and must be regulated accordingly – and what does not. This raises the question of whether the definition of genetic engineering in the Genetic Engineering Act needs to be fundamentally reviewed. Politicians, authorities, courts and the scientific community face the great challenge of dealing with this new situation and providing appropriate solutions for the regulation of genome-edited plants.

At this public debate, the German National Academy of Sciences Leopoldina, the German Research Foundation and the German Ethics Council will provide information on current developments in plant breeding and discuss the associated ethical and legal issues.