Table 4 Findings and recommendations concerning governmental SynBio regulation
From: Challenges for the European governance of synthetic biology for human health
Area of regulation | Recommendation |
|---|---|
GMO safety regulation | There is a need for dedicated investments in the development of risk assessment methods that match SynBio developments involving the construction of cells with multiple new traits and the introduction of engineered cells or viruses in the human body. |
There is a need to find a new and careful balance within the current system of GMO regulation so that it works to, on the one hand, facilitate innovation and, on the other hand, to prioritize new emerging issues of risk assessment. | |
Regulation of medicinal products and devices | There is a need to reconsider the current distinction between pharmaceuticals and devices in the process of medical product approval in Europe. |
There is a need to consider a more transparent process of ethical review, in which the results of research ethics evaluations are not only fed back to individual projects (as is the current practice within DG Research and Innovation), but to wider communities of researchers, patients, ethicists and social scientists. |