Arguments and Positions
Gene editing ranks among the major methodological innovations in molecular biology for over 20 years; it is of strategic importance to the life science industry. Gene editing is a collective term for methods with which DNA building blocks of microorganisms, plants and mammals can be edited in a more precise and pinpointed manner than ever before, i.e. genes can be turned on and off, repaired, inserted, removed, replaced or regulated. Compared with conventional methods, these techniques are uncomplicated, time-saving and cost-effective, and they are essential tools in research and development. They have many applications worldwide – ranging from basic research, medicine and biotechnological production to agriculture. The said techniques are essential not only in plant biotechnology but also in the production of bio-based products within a bioeconomy and, in particular, in medicine. Gene editing opens up extraordinary possibilities to decode diseases and to decisively improve prevention, therapy and cure – or to enable them in the first place.
ECJ ruling puts innovation at risk
The European Court of Justice (ECJ) dealt until July 2018 with the legal status of gene editing. The key question was whether it falls under the EU legislation on GMOs or whether the mutagenesis exemption – as laid down in this legislation – applies. Gene editing is also called "targeted mutagenesis". For example, in crop breeding it can bring about the same changes as traditional breeding methods or natural mutations. Its products are at least as safe for humans, animals and environment as crops bred with conventional methods.
All the same, the ECJ judges held that gene editing results in genetically modified organisms (GMOs) that require approval under the GMO legislation. This ruling is problematic, because it is based on law dating back to 2001 which, in turn, relies on the state of science of the 1980s. The ECJ did not give consideration to recent natural science assessments and new scientific findings.
This interpretation of the European GMO Directive blocks the enormous innovative potential of gene editing for agriculture, impairs urgently needed progress in medicine and obstructs efforts towards a bio-economy. Germany and Europe are bound to fall behind countries like China and the USA in all areas of biotechnology, both scientifically and econom-ically.
Use the chances – openly discuss risks
The public and legal environment for gene editing in Germany and the EU is in need of improvement. Large and small businesses of the life science industry should be able to use gene editing.
It is important for research-intensive products and processes to be not only developed in Germany and to be allowed to show their benefits fast. General and scientifically unfounded rejection also adversely affects medical, industrial and agricultural biotechnology.
- Science-based, case-by-case assessment of gene editing
The European GMO legislation should be adapted to the current state of development and knowledge in technology and natural science, and it should be open for new developments. Future laws should be oriented primarily to the hazard potential of organisms and not to the production method.
- Use the chances of gene editing in all fields of biotechnology
Following the example of the successful NanoDialog, ethical questions and potential risks could be discussed with politicians and societal stakeholders in a BioDialog of the German federal government. The government’s NanoDialog has decisively contributed to examining the chances and risks of nano-technology in an open and fair manner, supporting a responsible attitude towards and handling of nanomaterials. The same should be done for gene editing.