Grijze gebieden in de regulering van groene en rode biotechnologie: Naar veerkrachtige regelgeving voor snelle technologische veranderingen

It is a well-established fact that regulations can become outdated due to scientific and technological developments. This is also the case in the field of biotechnology, and more specifically in genetic modification, where regulations do not always keep up with rapid technological advancements. Besides, also due to societal developments regulations can become less adequate. As a result, grey areas inevitably arise, where there is uncertainty about the scope and interpretation of European and national regulations concerning genetically
modified organisms (GMOs). In the background, the ongoing question revolves around the balance between ensuring safety and facilitating innovation. Regulations that are not sufficiently adapted to new developments may, on one hand, allow potentially risky technological applications to escape regulation. On the other hand, outdated regulations may unnecessarily hinder innovation. The COGEM (Netherlands Commission on Genetic Modification) observes that the current GMO regulations are too out of step with new technological developments, resulting in compromised safety, hindered innovation, or both. The COGEM has asked the Erasmus School of Law to conduct research into the emergence of grey areas and explore possibilities for structuring legislation in a way that keeps up with rapid technological developments. In other words, how can legislation be made more resilient? This research consists of a theoretical exploration of the issue of grey areas and the possibilities for more resilient regulation (Part I), followed by two case studies (focusing on the use of cisgenesis in agriculture and the development of self-amplifying messenger RNA vaccines) in which we concretely explore in what ways a lack of resilience plays a role in the regulation of biotechnology (Part II). The findings from the case studies are then linked to the theoretical analysis in order to map the practical feasibility and potential challenges of different strategies to enhance the resilience of biotechnology regulation (Part III).