Olivia Hamlyn, Birkbeck, University of London
Regulating risky technologies, for example emerging nanotechnology and biotechnology, is a perennial challenge and the subject of significant research efforts over decades across various disciplines, including legal academia and Science and Technology Studies (STS).
That work often involves highlighting the limitations of ‘downstream’ regulation’, i.e. regulation applied to fully developed technology, for example, pre-market authorisation procedures. Such regulation often relies heavily on risk assessments to determine the safety or otherwise of a technology and tends to exclude consideration of broader, potential socio-economic, political and ethical implications concerning, amongst other things, the control, ownership and the distribution of risk and benefits associated with the technology as well as the need for, motivation behind and purpose of the technology. A significant limitation of this approach is that by this stage in a technology’s development, it is too late to address those implications and concerns or otherwise change course. Furthermore, risk-based governance has a track record of failing to predict the societal impacts of risky technologies, for example ozone-depleting CFCs and the pesticide DDT, in time to prevent harm.
More recently, research in STS has shifted its attention ‘upstream’, for example to the early stages of R&D, to focus on governing those processes with a view to shaping innovation trajectories in directions more desirable and beneficial to society. Responsible Innovation (RI) is an innovation governance framework which seeks to transform innovation processes by, in particular, encouraging anticipation (for example, considering the likely consequences of innovation), reflexivity (involving actors reflecting on their commitments and assumptions), inclusion (involving public deliberation regarding innovation) and responsiveness (i.e. that the direction of innovation should respond to broadly shared public values). The many tools available to support RI include technology assessment, technology foresight, ‘stage gating’, risk registers and various mechanisms for public debate and dialogue.
Legal academia, especially environmental law, has a history of drawing fruitfully on STS work criticising scientific risk assessment to inform its analyses of amongst other things, downstream, risk-based regulatory decision-making. It has, however, I argue, largely overlooked these more recent developments in STS regarding innovation governance and RI and their potential implications for the law including how, if at all, the law should respond.
In my recent article Synthesize this: integrating innovation governance and EU regulation of synthetic biology, published in the Journal of Law and Society (Vol 49, Issue 3, 2022) I argue for a renewed engagement by legal academia in these developments in STS research and consider how the law might adapt in light of, and to support, RI’s transformative ambitions.
Soft law currently represents the most likely route for implementing RI and soft mechanisms have been established, for example the BSI’s Responsible Innovation Guide, the OECD’s Recommendation on Responsible Innovation in Neurotechnology and SYNENERGENE the EU’s multi-year, multi-stakeholder dialogue exercise on synthetic biology. Soft law offers many advantages: it is flexible, it can respond more quickly to emerging technologies, it can clarify what exactly is being regulated, it can supplement existing regulation by, for example, setting out guidelines for compliance, it allows for collective learning and experimentation and can be hardened into law once we’re clearer about the issues and appropriate regulatory responses. There are, however, limitations, the most significant of which is that soft instruments are not enforceable. This can lead to low rates of compliance and participation amongst industry. In addition, the flipside of flexibility is uncertainty and indeed hard regulation may sometimes offer certainty, stability and clarity in an otherwise unpredictable technological landscape. Finally, the use of soft approaches has often been fragmented, piecemeal and ad hoc, creating confusion, complexity, overlaps as well as gaps and a lack of clarity over their interaction with the broader regulatory framework.
While hybrid approaches, combining soft and hard law, offer potential for mutually enhanced effectiveness, this lack of clarity poses particular problems when it comes to recruiting the law to help implement RI. Policy and scholarship on RI and RI activities rarely set out their implications for risk regulation. Exercises in public dialogue designed to identify desirable outcomes for innovation lack specific entry points in policy-making and opportunities to influence regulatory decisions. Likewise, downstream regulation proceeds largely without heed to the suites of RI activities seeking to shape upstream innovation processes. More broadly, experience demonstrates that existing legislative structures can inhibit or constrain soft or experimental measures. Innovation governance and regulation operate separately, despite the fact that the tools mentioned above (technology assessment etc.) were developed to complement downstream regulation and despite the need and potential for soft mechanisms to work with hard regulation throughout the innovation governance ‘continuum’.
Innovation policy and technology regulation are underpinned by assumptions regarding the purposes of innovation and the types of concerns worth addressing. Innovation policy tends to view all innovation as inherently good, an automatic generator of jobs and crucial to market creation, economic growth and competitiveness. The purpose of regulation is regarded as addressing the, often exclusively safety, impacts of innovation (hence the reliance on risk assessment) and ensuring the realisation of technology-derived economic gains.
By contrast, RI seeks to encourage science and innovation that pursue socially desirable outcomes, as collectively defined through RI processes. In order to transform innovation processes along these lines, soft approaches alone and as currently employed, are insufficient. Instead, the entire governance continuum should be viewed holistically and interventions at all stages of technology emergence – policy, RI activities and soft governance mechanisms upstream and midstream and hard downstream regulation – need to align. This includes considering how hard regulation itself might need to change. Rather than focusing solely on ensuring safety and economic gains, regulation should reflect those socially desirable outcomes – in its regulatory purpose, the types of information and considerations to be weighed in decision-making and in new procedures for assessing concerns other than – and in addition to – risk. Doing so may mean expanding RI itself to reflect on the purposes of regulation and its underpinning assumptions and to encourage the early involvement of policy-makers, legislators and regulators to ensure regulation responds to priorities emerging from upstream RI exercises and activities. There is no doubt that this would be extremely challenging. However, the potential to support the transformation of innovation processes by coordinating interventions across the governance continuum represents a valuable spur for legal academia and STS to open discussions.