Generic or Specific? The Frames of Stem Cell Procurement Regulation in Europe

Abstract

The procurement of stem cells, which is a crucial source-material in biomedical research promising the development of novel therapies in regenerative medicine, is subject to regulation using generic and technology-specific provisions throughout Europe. The relevant national regulatory regimes, while they share common regulatory frames, exhibit considerable differences as a matter of the regulatory approach followed, the biological level regulated, or of the context in which technologies for stem cell procurement are regulated. This variety indicates that legal regulation may resort to different means so as to secure a connection with the technology regulated. It is proposed that for improving “regulatory connection” states should consider engaging in regulatory borrowing from other systems covering both generic and specific instruments of technology regulation.