chapter  7
16 Pages

Through the thicket and across the divide: successfully navigating the regulatory landscape in life sciences research

WithGRAEME LAURIE AND SHAWN H. E. HARMON

The metaphor of the ‘regulatory landscape’ may be over-used, but its utility ensures its continuation. The metaphor is particularly apt for lawyers (working around the life sciences) because much of the responsibility for navigating the landscape is theirs. Within this landscape, law is often characterised – or caricatured – as both creator of problems and bringer of solutions. We argue that both accounts are true, but only in half-measure. While it is often said that law struggles to keep up with rapid advances in the life sciences, we focus on a particular aspect of this struggle, viz, it is not due to an absence of law but rather to the significant (and ever-expanding) space that law has come to occupy. The result is that law is often seen as a ‘thicket’: a complex, fragmented, and cumulative collection of instruments, institutions, and mechanisms that requires ever greater knowledge, time and capital to navigate, thereby imposing disproportionate costs on actors and requiring inordinate amounts of effort to move through.