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

Abstract

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.

Inovação Responsável no Âmbito da Gestão e Negócios

“…Outros estudos tratam de aspectos gerais da governança como cenários co-evolutivos (Robinson, 2009), quadros regulatórios do governo, voluntáriassociedade civil e coregulação (D'Silva et al, 2012), na capacidade de resposta na governança de RRI (Nielsen, 2016) e na relação entre governança e fatores cognitivos (Nielsen, 2016). Nesse caso, o conceito articula a necessidade de intercâmbio mútuo pelo qual os atores sociais se tornam receptivos uns aos outros no início da inovação, com o objetivo de facilitar a inovação eticamente aceitável e sustentável.…”

Responsible Innovation 2

“…soft law, co-regulation, selfregulation and voluntary reporting schemes) and more adaptive and anticipatory governance (e.g. Ferrari and Nordmann 2010;D'Silva et al 2012;Barré 2011;Kaza 2006). Nevertheless, public agencies and governmental bodies need to retain an important facilitative role (e.g.…”

Changing perspectives: analysing deliberative processes for the governance of science and technology

“…The RRI elements opening up, anticipating, reflecting, and responding are phrased or conceptualised as dimensions that can be pursued in different ways, possibly also via formal regulations. Although regulating highly innovative research fields has shortcomings (D'Silva et al, 2012), there already are some regulations which stimulate open access publications, require interdisciplinary teams, or require stakeholder consultation.…”