A game with rules in the making - how the high probability of waiting games in nanomedicine is being mitigated through distributed regulation and responsible innovation

摘要

The potential benefits of nanotechnologies in healthcare are widely expected to be enormous and a considerable amount of investment is already pouring into public research in this area. These high expectations of benefits are coupled with uncertainty surrounding the potential risks of the prospective products containing nanomaterials, in addition to concerns about the adequacy of regulatory oversight. These challenges add another level of uncertainty for those deciding to invest in nanotechnology R&D and threaten to impede product development and commercialisation. Nanotechnology in healthcare (often labelled as nanomedicine) presents a situation where waiting games are a strong possibility; however, waiting games have been avoided (so far) through the unlocking of the dominant regulation regime. This paper describes how an innovation impasse in nanomedicine could have ensued if the traditional wait and watch strategies of legislators and regulators had been followed. We describe how waiting games were avoided through the opening up and distribution of regulatory approaches.