Synthetic biology, concerns and risks: looking for a (constitutionally oriented) regulatory framework and a system of governance for a new emerging technology

The Doctoral thesis is about the relationship between synthetic biology and the law. It aims at elaborating a model of governance and regulation against the risks of synthetic biology, using the "prudent vigilance" approach and the human rights frame. Synthetic biology occupies a relevant position among the new emerging technologies. The potential applications of this field of research, characterized by the adoption of an engineering approach to life, together with a trend to converge between different technologies, span several fields. However, it could also generate numerous risks. This thesis aims at individuating a regulatory framework and a model of governance for addressing the risks and concerns arising within synthetic biology area. This is to ensure that the progress is not hindered but, at the same time, the problematic issues are not neglected or under evaluated. The suggested model is named " prudent vigilance" (inspired by the report about synthetic biology, drafted by the U.S. Presidential Commission on Bioethics, 2010), and it entails an ongoing and periodically revised process of assessment and management of all the risks and concerns, taking into account the interests of all the stakeholders in a dynamic, cooperative, democratic, open and transparent manner. Furthermore, it suggests the adoption of policies that are based on the principle of proportionality (among benefits and risks) and on a reasonable balancing between different interests and rights at stake. These policies should be taken through "hard law" and "soft law" sources, thus involving "actors" at all levels (governments, institutions, the scientific community and general public), and the enforcement and control of those policies should be exercised by judges coupled with independent professional bodies, where all the stakeholders are represented. The policies should also be oriented by a constitutional frame, that is represented by the protection of fundamental human rights emerging in the field of synthetic biology (right to life, right to health, dignity, freedom of scientific research, right to environment). After the theoretical explanation of the chosen model, the operability of it is "checked", by considering, as a case study, its application with reference to a specific risk brought up by synthetic biology - biosecurity risk, i.e. the risk of bioterrorism.