The Object-Based and Process-Based Regulation of Genome Editing.

The article explores whether the broader regulatory framework applicable to the member states of the EU contains suitable tools to react to the rapid advances in science, especially as to the question of germline editing technologies. From the perspective of EU member states, the regulatory framework is fragmented between norms of international law, secondary EU law and national legislation. The rules and their interpretation are strongly influenced by the concept of precaution, which reflects the concern that there is not enough knowledge to assess the impact of genome editing technology on individuals, society and future populations. However, the argument of precaution loses its strength with every new scientific discovery. The expanding knowledge in the field creates the need to replace regulation, which is based on the lack of knowledge (such as precautionary moratoriums) by the regulation that is based on the actual knowledge. The article reaches a conclusion that the EU framework for advanced treatments and medicinal products is in a state where it can, in principle, address the questions associated with the safety and efficacy of germline editing technologies. The EU framework is, however, not suitable to assess the moral and societal impacts of new technology, which should be left for member states.