Introduction: The Regulatory Challenges for Nanotechnologies

Hodge, Graeme; Bowman, Diana M.; Maynard, Andrew D.

doi:10.4337/9781849808125.00008

Cited by 4 publications

(1 citation statement)

References 14 publications

(20 reference statements)

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“…Nanotechnologies are predicted to have an impact on almost every aspect of society; however, there is increasing concern that they will also bring unforeseen human and environmental health and safety risks (Van Calster, Bowman, and D'Silva 2011, 85;Parandian, Rip, and te Kulve 2012, in this issue). As government, industry and scientists race to determine and evaluate the potential risks posed by some aspects of nanotechnologies -particularly free engineered nanoparticlesthere have been increasing calls for governments and other stakeholders to evaluate the adequacy of current regulatory regimes for the various current and future applications of the technology (Van Calster, Bowman, and D'Silva 2011, 86;Hodge et al 2010;Maynard et al 2010). These include calls for new legislation (Davies 2006) up to a moratorium on development until adequate regulation can be assured (see, ETC 2006(see, ETC , 2010.…”

Section: Introductionmentioning

confidence: 99%

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

D’Silva

Robinson

Shelley-Egan

2012

Technology Analysis & Strategic Management

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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.

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Section: Introductionmentioning

confidence: 99%