Synthetic biology as a new threat to biosecurity. Is there a road to suitable governance?

Synthetic biology, which is a new emerging technology aiming at re-writing existing biological systems and designing completely new parts and devices, brings several potential benefits, but at the same time it constitutes a new threat to biosecurity: for such “double Janus face”, it can be considered as a “dual use research”. Indeed, the risk that its theoretical discoveries and applications are handled by bioterrorists and used for malevolent purposes is not a mere hypothesis. Therefore, it is necessary to look for possible solutions for the governance of this type of risk. In order to try to achieve such purpose, the analysis focuses, first of all, on the overview of the existing regulations against bioterrorism. Then, these regulations are evaluated in the light of the constitutional frame of fundamental rights at stake (in the belief that any policy/regulation should take into account and be based on the respect of fundamental rights). Thirdly, the applicability of the existing regulatory framework to synthetic biology is checked. Fourthly, the different positions that have been proposed so far for addressing biosecurity risks in the area of synthetic biology are shown and put into comparison. Finally, the proposal of a model of governance, called of “prudent vigilance”, is described.