030050 KU How to Regulate in the Absence of Knowledge? New Technologies and (EU) Law (2022S)

How to provide for rules with regard to technologies or processes the (full) impact and consequence of which are (yet) unknown? That is, in the nutshell, the question that has been plaguing the European and national legislators, and subsequently the courts, for the last decades. It is also the central question of this course. The course starts with a series of case studies, diving into the issues such as genetically modified organisms and new plant varieties; new foodstuffs, food additives, active chemical substances; vaccination and liability, and various emergency measures adopted in exceptional, in particular pandemic, situations. On the basis of such case studies, the attention then turns to the transversal issues such as: who is best to legislate in these areas and how; how authorisations procedures are to be carried out and to what standard; where shall the burden of proof lie; what is the proper reach of the precautionary principle; the limits of judicial review in such cases; the (extra-) territorial reach of such rules and their effective enforcement, connecting the national, European, and indeed global levels of governance; the questions of the allocation of risks in various regulatory models, and its impact on the research and development; before concluding with a reflection on deeper (bio)ethical and social issues, in particular what ought the “European” approach in regulating uncertainty be, if there in fact can be one.