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Synthetic biology is a series of scientific and technological practices involved in the application of engineering principles to the design and production of predictable and robust biological systems. While policy discussions abound in this area, emerging technologies like synthetic biology present considerable challenges in the articulation of concrete policy options given that their introduction into society may still be in the distant future. This paper reports on a series of governance workshops that focused on synthetic biology’s ethical, legal, and social implications (ELSI) as they pertain to human health, and discusses particular limitations of the ELSI approach that we encountered in our work. In an attempt to avoid policymaking for potential implications of uncertain future applications we instead conclude by proposing tangible forms of anticipatory governance that may be more adequate in addressing the more immediate concerns raised by synthetic biology.

Valorization of knowledge has been defined as a major challenge in the context of genomics as an emerging strategic research field. Valorization is a Dutch science-policy concept for what is elsewhere called science impact or the third mission of universities. This article describes the institutionalization of valorization policy in the Dutch genomics research system as a specific manifestation of a changing social contract between science and society, which mainly targets economic value creation and the stimulation of entrepreneurship. A societal debate has emerged in which this focus on economic aspects has been strongly criticized as one-sided. In response, policy-makers are willing to adopt a broader definition of valorization. On the basis of an analysis of valorization policies and practices in Dutch medical genomics, this article draws attention to two myths in this valorization debate.

Developments in public health genomics (PHG) hold the promise to be beneficial for individuals and to promote public health. Central to this paper is the idea that given the range of uncertainties and ambiguities related to genome-based information and technologies (GBIT), the responsible introduction of GBIT in health care systems requires an incremental approach. The paper highlights policy issues connected to two major shifts connected to developments in PHG that challenge traditional boundaries. First, the introduction of GBIT in health care systems challenges the boundary between research and clinical care. It entails complex data flows that raise a number of issues relating to infrastructural demands, intellectual property, data security and privacy, tensions between the needs of research and the needs of the individual, patient rights and professional responsibilities, and the potential feedback of (re)analysed data. Secondly, the introduction of GBIT in health care systems challenges the boundary between clinical care (particularly diagnostics) and screening. Both diagnostics and screening involve potentially large amounts of information about an individual’s genome, and raise new and challenging issues concerning quality assessment and how to deal with unsolicited information that might be generated from these tests. These issues could arise in a variety of health care settings in which whole genome sequencing tests find further application in established and new practices of diagnostics and screening. The possibility of screening the whole genome raises the question of what to screen for and when, and whether existing evaluative frameworks – concerning quality assessment and ethical and legal aspects of GBIT – are robust enough, or require fine-tuning. These shifts have implications for the relations between all stakeholders. The responsible introduction of GBIT in the health care system thus requires an early dialogue in which these stakeholders are activ, Developments in public health genomics (PHG) hold the promise to be beneficial for individuals and to promote public health. Central to this paper is the idea that given the range of uncertainties and ambiguities related to genome-based information and technologies (GBIT), the responsible introduction of GBIT in health care systems requires an incremental approach. The paper highlights policy issues connected to two major shifts connected to developments in PHG that challenge traditional boundaries. First, the introduction of GBIT in health care systems challenges the boundary between research and clinical care. It entails complex data flows that raise a number of issues relating to infrastructural demands, intellectual property, data security and privacy, tensions between the needs of research and the needs of the individual, patient rights and professional responsibilities, and the potential feedback of (re)analysed data. Secondly, the introduction of GBIT in health care systems challenges the boundary between clinical care (particularly diagnostics) and screening. Both diagnostics and screening involve potentially large amounts of information about an individual’s genome, and raise new and challenging issues concerning quality assessment and how to deal with unsolicited information that might be generated from these tests. These issues could arise in a variety of health care settings in which whole genome sequencing tests find further application in established and new practices of diagnostics and screening. The possibility of screening the whole genome raises the question of what to screen for and when, and whether existing evaluative frameworks – concerning quality assessment and ethical and legal aspects of GBIT – are robust enough, or require fine-tuning. These shifts have implications for the relations between all stakeholders. The responsible introduction of GBIT in the health care system thus requires an early dialogue in which these stakeholders are activ

Nanotechnology has provided a new window of opportunity to reframe state-science-society relationships. In particular the notion of upstream public engagement has been put forward. But while public engagement is seen as indispensable in the governance of science and technology (S&T) there still is a need to reflect on why, how, for who and by whom public engagement has to be organised. This paper describes a wide range of activities that were organised in the Netherlands to bring a public perspective into the development of nanotechnology. Our study shows that in order to better understand the complexities of the governance of science and technology, a new research perspective is needed. By reflecting on the relationship between informing and engaging, on the interaction between engagement processes within the societal, scientific and political sphere, and on organisational and institutional constraints, we present an outline of such a new research perspective. As well, we identify key themes for comparative research in governance of S&T within different countries.

In the STOA project Making Perfect Life four fields were studied of 21st century bio-engineering: engineering of living artefacts, engineering of the body, engineering of the brain, and engineering of intelligent artefacts. This report describes the main results of the project. It shows how developments in the four fields of bio-engineering are shaped by two megatrends: "biology becoming technology" and "technology becoming biology". These developments result in a broadening of the bio-engineering debate in our society. The report addresses the long term views that are inspiring this debate and discusses a multitude of ethical, legal and social issues that arise from bio-engineering developments in the fields described. Against this background four specific developments are studied in more detail: the rise of human genome sequencing, the market introduction of neurodevices, the capturing by information technology of the psychological and physiological states of users, and the pursuit of standardisation in synthetic biology. These developments are taken in this report as a starting point for an analysis of some of the main European governance challenges in 21st century bio-engineering.

During the last decades several tools have been developed to anticipate the future impact of new and emerging technologies. Many of these focus on ‘hard,’ quantifiable impacts, investigating how novel technologies may affect health, environment and safety. Much less attention is paid to what might be called ‘soft’ impacts: the way technology influences, for example, the distribution of social roles and responsibilities, moral norms and values, or identities. Several types of technology assessment and of scenario studies can be used to anticipate such soft impacts. We argue, however, that these methods do not recognize the dynamic character of morality and its interaction with technology. As a result, they miss an important opportunity to broaden the scope of social and political deliberation on new and emerging technologies. In this paper we outline a framework for building scenarios that enhance the techno-moral imagination by anticipating how technology, morality and their interaction might evolve. To show what kind of product might result from this framework, a scenario is presented as an exemplar. This scenario focuses on developments in biomedical nanotechnology and the moral regime of experimenting with human beings. Finally, the merits and limitations of our framework and the resulting type of scenarios are discussed., During the last decades several tools have been developed to anticipate the future impact of new and emerging technologies. Many of these focus on ‘hard,’ quantifiable impacts, investigating how novel technologies may affect health, environment and safety. Much less attention is paid to what might be called ‘soft’ impacts: the way technology influences, for example, the distribution of social roles and responsibilities, moral norms and values, or identities. Several types of technology assessment and of scenario studies can be used to anticipate such soft impacts. We argue, however, that these methods do not recognize the dynamic character of morality and its interaction with technology. As a result, they miss an important opportunity to broaden the scope of social and political deliberation on new and emerging technologies. In this paper we outline a framework for building scenarios that enhance the techno-moral imagination by anticipating how technology, morality and their interaction might evolve. To show what kind of product might result from this framework, a scenario is presented as an exemplar. This scenario focuses on developments in biomedical nanotechnology and the moral regime of experimenting with human beings. Finally, the merits and limitations of our framework and the resulting type of scenarios are discussed.

De gestage groei in de afgelopen tien jaar van het areaal genetisch gemodificeerde (gg-) gewassen in de wereld lijkt zich ook in de toekomst voort te zetten. Hiermee zal ook de hoeveelheid en het aantal gg-landbouwproducten op de wereldmarkt sterk toenemen. Binnen Europa worden echter nauwelijks gg-gewassen geteeld, vanwege een sterk tegen gg-gewassen gekante maatschappelijke opinie. De huidige kloof tussen de ontwikkelingen binnen en buiten Europa roept de vraag op wat de positie van Europa en Nederland ten opzichte van genetische modificatie in de landbouw in de toekomst zal zijn, en welke keuzes en beleidsvragen hieraan verbonden zijn. Het Rathenau Instituut en de COGEM hebben daarom een verkennende scenariostudie uitgevoerd naar de situatie voor ggo’s in de landbouw in Europa. Aan de hand van twee ‘drivers’ - ‘maatschappelijke acceptatie in de EU (en Nederland)’ en ‘externe druk’ - die zowel bepalend zijn voor de ontwikkelingen als onzeker over de richting waarin ze zich ontwikkelen, kunnen vier scenario’s of werelden worden onderscheiden. In alle scenario’s worden Nederland en Europa geprojecteerd tegen de achtergrond van een wereld die wel ggo’s teelt, net als in de huidige situatie. In het eerste scenario ‘GGO’s als Luxe’ bestaat er geen externe druk of noodzaak voor het telen van gg-gewassen in Europa, terwijl tegelijkertijd de maatschappelijke acceptatie hoog is. De consument kan kiezen voor zowel ggo als ggo-vrij in combinatie met een breed scala aan keurmerken betreffende gezondheids- en duurzaamheidsclaims. In dit scenario krijgt de ‘biobased economy’ de gelegenheid om sterk te groeien. Als er sprake is van zowel externe druk om gg-gewassen te telen en te importeren als een hoge maatschappelijke acceptatie van ggo’s, kan het scenario ‘Mondiale Motivatie’ ontstaan. De productie van voedsel moet wereldwijd toenemen en hiertoe worden alle mogelijke middelen ingezet. De meeste consumenten zien genetische modificatie als een belangrijke deeloplossing voor de, De gestage groei in de afgelopen tien jaar van het areaal genetisch gemodificeerde (gg-) gewassen in de wereld lijkt zich ook in de toekomst voort te zetten. Hiermee zal ook de hoeveelheid en het aantal gg-landbouwproducten op de wereldmarkt sterk toenemen. Binnen Europa worden echter nauwelijks gg-gewassen geteeld, vanwege een sterk tegen gg-gewassen gekante maatschappelijke opinie. De huidige kloof tussen de ontwikkelingen binnen en buiten Europa roept de vraag op wat de positie van Europa en Nederland ten opzichte van genetische modificatie in de landbouw in de toekomst zal zijn, en welke keuzes en beleidsvragen hieraan verbonden zijn. Het Rathenau Instituut en de COGEM hebben daarom een verkennende scenariostudie uitgevoerd naar de situatie voor ggo’s in de landbouw in Europa. Aan de hand van twee ‘drivers’ - ‘maatschappelijke acceptatie in de EU (en Nederland)’ en ‘externe druk’ - die zowel bepalend zijn voor de ontwikkelingen als onzeker over de richting waarin ze zich ontwikkelen, kunnen vier scenario’s of werelden worden onderscheiden. In alle scenario’s worden Nederland en Europa geprojecteerd tegen de achtergrond van een wereld die wel ggo’s teelt, net als in de huidige situatie. In het eerste scenario ‘GGO’s als Luxe’ bestaat er geen externe druk of noodzaak voor het telen van gg-gewassen in Europa, terwijl tegelijkertijd de maatschappelijke acceptatie hoog is. De consument kan kiezen voor zowel ggo als ggo-vrij in combinatie met een breed scala aan keurmerken betreffende gezondheids- en duurzaamheidsclaims. In dit scenario krijgt de ‘biobased economy’ de gelegenheid om sterk te groeien. Als er sprake is van zowel externe druk om gg-gewassen te telen en te importeren als een hoge maatschappelijke acceptatie van ggo’s, kan het scenario ‘Mondiale Motivatie’ ontstaan. De productie van voedsel moet wereldwijd toenemen en hiertoe worden alle mogelijke middelen ingezet. De meeste consumenten zien genetische modificatie als een belangrijke deeloplossing voor de

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