The paper addresses the question of adaptation of existing regulatory frameworks in the face of innovation in biotechnologies, and specifically the roles played in this by various expert knowledge practices. We identify two overlapping ideal types of adaptation: first, the stretching and maintenance of a pre-existing legal framework, and second, a breaking of existing classifications and establishment of a novel regime. We approach this issue by focusing on varieties of regulatory knowledge which, contributing to and parting of political legitimacy, in (...) principle enable the making of legally binding decisions about risks and benefits of technologies. We base the discussion around two case studies, one of animal biotechnology ethical regulation, the other of ‘advanced therapy’ medicinal product regulation, both in the context of European Union frameworks. Specifically, we explore the knowledge configurations constituting expert committees and other institutional formations of expert regulatory knowledge in their political context. We show that where sectoral and moral boundaries are challenged, different modes of regulatory knowledge beyond scientific forms – legal, procedural, moral, economic and industrial – can shape regulatory innovations either by maintenance of regimes through commensuration and stretching, or through differentiation and separation creating new frameworks. We conclude that establishing an essential techno-scientific difference between pre-existing and novel technologies does not in itself require new regulatory structures, and that the regulatory strategy that is followed will be determined by a combination of different forms of knowledge. (shrink)

Human/animal relations are potentially controversial and biotechnologically produced animals and animal-like creatures – bio-objects such as transgenics, clones, cybrids and other hybrids – have often created lively political debate since they challenge established social and moral norms. Ethical issues regarding the human/animal relations in biotechnological developments have at times been widely debated in many European countries and beyond. However, the general trend is a move away from parliamentary and public debate towards institutionalized ethics and technified expert panels. We explore by (...) using the conceptual lens of bio-objectification what effects such a move can be said to have. (shrink)

Governments have used several mechanisms to deal with intractable policy conflicts about issues in bioethics. One mechanism is the installment of an ethics committee and another one is the organization of public debates. Often, ethics committees have an implicit or explicit role in the stimulation of such public debate. However, this role is not self-evident and we therefore analyse the relation between committees and public debate. What should the function of biotechnology ethics committees be, how does this relate to their (...) composition, and to what extent are these functions met in practice? To this end, we have examined the three national committees of the Netherlands, Switzerland, and Australia in the field of animal and plant biotechnology. We argue that there is often a mismatchbetween the goals one wants to reach by stimulating public debate and the way this has been given shape, partly through ethics committees. In fact, installing (biotechnology) ethics committees is to a certain extent a premature move that contains rather than stimulates public debate. (shrink)

Governments have used several mechanisms to deal with intractable policy conflicts about issues in bioethics. One mechanism is the installment of an ethics committee and another one is the organization of public debates. Often, ethics committees have an implicit or explicit role in the stimulation of such public debate. However, this role is not self-evident and we therefore analyse the relation between committees and public debate. What should the function of biotechnology ethics committees be, how does this relate to their (...) composition, and to what extent are these functions met in practice? To this end, we have examined the three national committees of the Netherlands, Switzerland, and Australia in the field of animal and plant biotechnology. We argue that there is often a mismatchbetween the goals one wants to reach by stimulating public debate and the way this has been given shape, partly through ethics committees. In fact, installing (biotechnology) ethics committees is to a certain extent a premature move that contains rather than stimulates public debate. (shrink)

End of April 2021, the European Commission published its study on New Genomic Techniques (NGTs). The study involved a consultation of Member States and stakeholders. This study reveals a split on whether current legislation should be maintained or adapted to take account of scientific progress and the risk level of NGT products. This split was predictable. New technological developments challenge both ethical viewpoints and regulatory institutions; and contribute to the growing divide between science and society that value ‘technological innovations’ differently. (...) Such controversies are often characterized as ‘unstructured’ because of nearly unbridgeable positions on entangled scientific and value-laden issues. Initiatives for stakeholder involvement, such as consultation or participation, often focus on reaching a ‘shared vision’ without exploring the diverse societal concerns and values behind these positions. To resolve the EU stalemate in NGT regulation, we advocate to bring back politics in the EU decision-making process instead of hiding it under the veil of science, the need for regulatory change and public support. A more productive and justified use of genuine stakeholder participation is possible, if participants and deliberation design meet the criteria of what we call _participation ethics_. Drawing from our applied experience exploring the ethics of genetic modification, we believe that this approach can lead to more robust political decision-making and restore societal confidence in the governance of contested issues such as NGTs. (shrink)

This edited volume covers new ground by bringing together perspectives from symbolic legislation theory on the one hand, and from biolaw and bioethics on the other hand. Symbolic legislation has a bad name. It usually refers to instances of legislation which are ineffective and that serve other political and social goals than the goals officially stated. Recently, a more positive notion of symbolic legislation has emerged in legislative theory. From this perspective, symbolic legislation is regarded as a positive alternative to (...) the more traditional, top-down legislative approach. The legislature no longer merely issues commands backed up with severe sanctions, as in instrumental legislation. Instead, lawmakers provide open and aspirational norms that are meant to change behavior not by means of threat, but indirectly, through debate and social interaction. Since the 1990s, biomedical developments have revived discussions on symbolic legislation. One of the reasons is that biomedical legislation touches on deep-rooted, symbolic-cultural representations of the biological aspects of human life. Moreover, as it is often impossible to reach consensus on these controversial questions, legislators have sought alternative ways to develop legal frameworks. Consequently, communicative and interactive approaches to legislation are prominent within the governance of medical biotechnology. The symbolic dimensions of biolaw are often overlooked. Yet, it is clear that the symbolic is at the heart of many legal-political debates on bioethical questions. Since the rise of biomedical technologies, human body materials have acquired a scientific, medical and even commercial value. These new approaches, which radically question existing legal symbolizations of the human body, raise the question whether and how the law should continue to reflect symbolic values and meanings. Moreover, how can we decide what these symbolic values are, given the fact that we live in a pluralistic society? (shrink)