European governance challenges in 21st century bio-engineering

This Final Report discussed four case studies (whole genome sequencing, neuromodulation, biocybernetic adaptation and standardization in synthetic biology) focusing on particular developments in the four fields of 21st-century bio-engineering that were explored more extensively in the earlier Monitoring Report (respectively, the engineering of the body, the brain, intelligent artefacts and living artefacts). The aim of the case studies was to inform and stimulate political debate in the European Parliament by highlighting the bio-engineering developments in each field that have more immediate implications for European policymaking. To make the governance challenges that are posed by these developments more transparent for policymakers, this report introduced a conceptual framework which uses two dimensions in the description of the cases. One dimension refers to the variety of sociotechnical practices in which new bio-engineering developments are taking shape, while the other refers to the patchwork of regulatory practices that may be affected by these developments. The four case studies show that new bio-engineering technologies are being developed and adopted in a wide variety of sociotechnical practices, involving different applications and actors. New bio-engineering technologies may be adopted in relatively stable sociotechnical practices, but may also lead to significant changes to established practices or to newly emerging practices. The case studies further explored how this dynamics affects current regimes of regulation relevant to the different sociotechnical practices in which new bio-engineering technologies are taking shape. With regard to this regulatory dimension, three situations can be distinguished. Current regimes of regulation may be perceived as adequate, as being put under pressure, or as no longer adequate (or lacking). On the basis of this conceptual framework we can map the bio-engineering developments described in the different case studies along two dimensions, providing us with an overview of (1) the ways in which sociotechnical practices are being shaped and/or reshaped by new bioengineering technologies and (2) the extent to which established regulatory regimes are being challenged by these changing practices. In reference to these two dimensions and the dynamics between them, this chapter discusses the nature of the governance challenge that European policymakers face. The fundamental governance challenge, as we will argue, is to attune these two dimensions. In other words, how can we align the dynamics of sociotechnical and regulatory practices with respect to the four cases of 21st-century bio-engineering studied in this report? We have identified twenty different sociotechnical practices that are being shaped and/or reshaped by or are emerging from the bio-engineering technologies presented in the four case studies. An important question for policymakers raised by this sociotechnical dynamics is to what extent current regulatory practices are able to adequately respond to the short-term and long-term implications of the bio-engineering technologies studied here. As the case studies have made clear, there is already a patchwork of regulatory practices in place in the different fields of bio-engineering. Thus, the precise question is: To what extent can current regimes of regulation be perceived as adequate or in need of change? The findings from the four case studies strongly indicate that bio-engineering in the 21st century will pose a clear regulatory challenge to European politics and policymakers, especially with regard to issues of safety, privacy, bodily and mental integrity, informed consent, transparency and harmonization. The simultaneous impact of bio-engineering technologies on a diversity of existing or emerging sociotechnical practices reveals that the regulatory challenge will often be multifaceted. Existing regulatory frameworks can thus be seen as partly adequate, partly under pressure and partly inadequate, depending on the sociotechnical practice under consideration. This chapter distinguishes two different situations in which potential tensions and misalignments between sociotechnical and regulatory practices may occur: the regulatory zone and the regulatory wasteland. In the regulatory zone, sociotechnical practices are guided by established regulations that may be considered robust enough to deal with changing or newly emerging practices. In other words, the regulations in place can be considered future-proof in their potential to be adapted to or realigned with changing or new sociotechnical practices. In the regulatory wasteland, regulations are lacking or may be seen as inadequate to guide existing, changing or newly emerging sociotechnical practices. In this situation, there will be a genuine need for changes in existing regulations or for the development of new forms of regulation. As we point out in this chapter, the need for the alignment of sociotechnical and regulatory practices poses a governance challenge which is both fundamental and difficult because it relates to future developments which may have a great impact but which are also uncertain in several respects. When dealing with this governance challenge, above all policymakers face technoscientific uncertainty, that is, uncertainty about the speed, direction and nature of technological change in 21st-century bio-engineering. Technoscientific developments may also change the social and political values that inform the societal and political debate concerning notions such as autonomy or privacy for example, and thus may create uncertainties about the values that should underpin regulatory initiatives. Finally, policymakers face uncertainty about the adequateness of existing regulatory frameworks, that is, about the alignment or misalignment of sociotechnical and regulatory practices in the near or more distant future. These various uncertainties lead to different and sometimes conflicting opinions about the potential impact of bio-engineering developments and the regulatory challenges that may arise from them. Therefore, in our view, political debate is required to determine the nature and urgency of the governance challenges in 21st-century bio-engineering and the ways to deal with these challenges. Accordingly, our analysis distinguishes three different options for governance which correspond to different interpretations of the bio-engineering developments discussed in the four case studies. The recurrent political question is whether future sociotechnical practices enabled by new bio-engineering developments can be considered substantially equivalent to sociotechnical practices with which we are already familiar: • If this is the case, it can be safely assumed that established regulations for these practices will also apply to the new bio-engineering developments and a wait-and-see strategy would be an appropriate option for governance • If there are reasons for doubt about the equivalence of new sociotechnical practices to already existing forms, the monitoring and assessment of these developments would be an appropriate governance option to determine whether current regulations are adequate • If new bio-engineering developments lead to sociotechnical practices that are evidently different from present practices, existing regulatory frameworks may have to be revised (within the regulatory zone) or new forms of regulation may have to be developed (within the regulatory wasteland) Our concluding reflections on the findings of the different case studies indicate which policy options are most appropriate according to the assessment presented in each case, which is based on consultation with various experts. In the case of whole genome sequencing and biocybernetic adaptation, it was argued that future changes in sociotechnical practices will urge policymakers to start revising and harmonizing existing regulatory frameworks. In addition, new sociotechnical practices are emerging which might require new forms of regulation in the near future. In the case of neuromodulation, it was found that, in general, current regulations are adequate, but need more clarification, transparency and monitoring on various specific points. In the case of synthetic biology, no particular governance options were recommended, on the grounds that the future of this field is too uncertain to promote a particular strategy. We simply do not know whether synthetic biology will become a real game changer. In the Monitoring Report we argued for a broadening of activities in the field of bioethics because in the 21st century the bio-engineering debate no longer solely concerns the life sciences, but also NBIC convergence. From our analysis in the Final Report it becomes clear that we should not only broaden the field of bioethics, but also move beyond bioethics to biopolitics. The report namely reveals that bio-engineering in the 21st century poses a major challenge to European politics and policymakers. This implies that the governance of bio-engineering in the 21st century not only concerns stimulating scientific reflection and public debate on technological change and its societal implications, but also the political regulation of shifting and newly emerging sociotechnical practices in society. Politicizing bio-engineering developments thus requires more attention to regulatory uncertainties raised by bio-engineering developments. Policy recommendations • In order to increase institutional reflexivity and strengthen the preparedness of the European Parliament and other European institutions to deal with the governance challenges raised by bio-engineering in the 21st century, politicians and policymakers need to pay more close attention to the experiences of institutions which deal with regulation and its uncertainties • To empower the current European political system to democratically guide bioengineering in the 21st century, a dedicated and continuous effort is required to make the complex workings and failings of the relevant regulatory systems politically transparent with respect to the present and coming years