Soeteman-Hernández Lya G, Sutcliffe Hilary R, Sluijters Teun, van Geuns Jonathan, Noorlander Cornelle W, Sips Adriënne J A M
National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
TIGTech/SocietyInside, UK.
NanoImpact. 2021 Jan;21:100301. doi: 10.1016/j.impact.2021.100301. Epub 2021 Jan 28.
A vision for modernization of nanotechnology innovation governance is a Safe Innovation Approach (SIA). SIA combines two concepts: Safe-by-Design (SbD) and Regulatory Preparedness (RP). SbD aims to motivate industry to integrate safety considerations early in the innovation process and onwards. RP aspires to improve the anticipation capabilities of regulators and develop legislation that can keep pace with innovations. The pace, scope and complexity of nanotechnology present novel challenges for governance, especially law and regulation. A possible option forward for nanotechnology is to move towards a more goal-based governance system including anticipatory regulation. Anticipatory regulation and experimentation can be considered as an agile approach with emphasis on flexibility, collaboration and innovation. SIA can be seen as part of experimentation in support of agile regulatory practices. A trusted environment is needed in which innovators, regulators and other stakeholders are motivated to understand each other's concerns and together develop solutions to anticipate and address safety whilst also facilitating the development of safe, sustainable and socially beneficial innovations. Trust drivers to facilitate trusted environments include focusing on the public interest, competence, respect, integrity, inclusion, fairness and openness. Here, we explore the concept of building trusted environments in the context of the SIA for nanotechnologies.
纳米技术创新治理现代化的愿景是一种安全创新方法（SIA）。SIA结合了两个概念：设计即安全（SbD）和监管准备（RP）。SbD旨在激励行业在创新过程早期及之后整合安全考量。RP致力于提高监管机构的预期能力，并制定能够跟上创新步伐的法规。纳米技术的发展速度、范围和复杂性给治理，尤其是法律和监管带来了新的挑战。纳米技术未来可能的一个选择是朝着更基于目标的治理体系发展，包括预期性监管。预期性监管和实验可被视为一种灵活的方法，强调灵活性、协作和创新。SIA可被视为支持灵活监管实践的实验的一部分。需要一个可信赖的环境，在其中创新者、监管机构和其他利益相关者有动力去理解彼此的关切，并共同开发解决方案，以预测和解决安全问题，同时促进安全、可持续和社会效益良好的创新的发展。促进可信赖环境的信任驱动因素包括关注公共利益、能力、尊重、诚信、包容、公平和开放。在此，我们在纳米技术的SIA背景下探讨构建可信赖环境的概念。
