TranSTEP and synthetic biology in Germany

By Nils Heyen, Davy van Doren and Thomas Reiß, Fraunhofer Institute for Systems and Innovation Research ISI (November 2014)

Synthetic biology is an emerging interdisciplinary domain that focuses on the design of biological parts and systems. Despite synthetic biology’s envisioned contribution in tackling various global challenges, there is a high degree of uncertainty regarding its potential impacts, benefits and risks. Germany in particular faces a challenging conflict in terms of policy making and regulations, showing large potential to develop synthetic biology but also with a general critical public opinion on genetic modification. Here, we briefly outline how TranSTEP – an approach that aims for integrating perspectives from different assessment domains and disciplines – might support assessment and decision making processes in the case of synthetic biology.

The context of synthetic biology in Germany

In the past decade, synthetic biology has grabbed the attention of policy makers due to its envisioned future technological potential. The German context seems well suited to facilitate synthetic biology’s progression since Germany’s strong history with respect to its engineering and chemical sectors aligns with synthetic biology’s engineering focus and its applicability for chemical production. On the other hand, there is a lack of clarity regarding Germany’s transformation of its available resources into developing synthetic biology. Federal support and formal engagement in the creation of synthetic biology related networks and research programmes still seems limited.

In a German parliamentary enquiry in 2011, the federal support of synthetic biology R&D was formally denied by federal representatives. This, in turn, was criticised by a German NGO claiming federal support to be present ‘in disguise’ by taking advantage of present confusion with respect to synthetic biology’s definition. This led to controversy regarding Germany´s federal interpretation of synthetic biology and the potential institutional evasion of existing ethical, environmental, safety and security oriented debates.

Although relatively minor, this small political dispute illustrates the degree of uncertainty among policy and decision makers dealing with this emerging techno-scientific domain. Assessments are a means to reduce uncertainty through providing policy makers with knowledge that is able to inform the governance of synthetic biology. In the EST-Frame project, we reviewed the state of synthetic biology assessments in Germany.

The assessment landscape for synthetic biology in Germany

Overall, it can be said that the current state of synthetic biology assessments in Germany is characterised by its rather early developmental stage. A first wave of assessments (2009-2012; authored by science organisations, industry and NGOs) were mainly self-initiated with an important and often explicit interest to position itself in arising debates on synthetic biology. In 2012, the first assessment appeared (authored by the Central Committee on Biological Safety) that can be traced back to a mandate given by a public authority. This benchmarks a second wave of assessments (2012-today; authored by TA actors) commissioned directly by the political system.

The nature of the reviewed synthetic biology assessments in Germany might seem to fit the immature developmental stage of the technology itself. Content wise, however, there seems unused potential to complement the observed generic and abstract assessment approaches with increased differentiation regarding synthetic biology’s diverse application domains, time horizons, visions and concrete scenarios. Methodologically, the missing use of participatory approaches in German assessments seems to limit the scope of different perspectives, statements and opinions.

The TranSTEP approach and synthetic biology

In the EST-Frame project, we organised an international workshop in order to virtually simulate the first steps of TranSTEP applied on synthetic biology, including convening a trans-domain team, situation analysis and problem framing. Hence, the 11 international participants representing different stakeholders (science/industry, NGOs, civil service) and various assessment domains (economic, risk, ethical assessment, TA, STS, foresight) acted as our TranSTEP team. As is well known from similar exercises, the initiated open dialogue between experts with such highly diverse backgrounds proved to be an enormous challenge for both the participants and the facilitators. However, the situation analysis of the group also showed the strong need for integrating diverse perspectives on synthetic biology. After long and intensive discussions it finally became apparent that this integration is nearly impossible to achieve as long as it remains on a generic and abstract level. Therefore, it was decided to focus on a specific application case and to examine this case with respect to all important general issues raised. The subsequent session was the most constructive part of the workshop since all participants were engaged in finding solutions for the contested issues. Finally, all participants agreed on a specific case example (“genetically modified/engineered mosquitoes and flies using DNA-synthesis”), on a definite problem framing and a list of questions the envisioned integrated assessment should tackle. It goes without saying that achieving a mutual consent across such diverse perspectives is far from being ordinary.

Following the TranSTEP approach, this trans-domain team would be further guided through a process that allows for both gaining knowledge and integrating findings in order to answer the selected, widely debated, generic issues concretely applied to the chosen case example. This would not only contribute to fill a gap in the current assessment landscape, but could also, depending on the results, benefit the governance of synthetic biology.

In the case of synthetic biology in Germany, the point of TranSTEP would be to convene assessment practitioners and stakeholders (including active researchers in synthetic biology) who usually do not work together and to make them conduct an integrated assessment project. Whereas some assessment practitioners (e.g. from the TA domain) might be used to such inter­disciplinary endeavours, TranST­EP strives to include also experts from domains that are usually not part of these practices (e.g. from risk, economic, and impact assessment). Further­more, TranSTEP explicitly includes the collaborative definition and framing of issues, situation analysis and method reflection. In many previous assessment practices on synthetic biology in Germany, these activities were rather pre-defined and therefore excluded from the assessment. TranSTEP considers these often neglected but decisive steps as an explicit part of an integrated assessment and leaves them to the trans-domain team who is finally also responsible for conducting the assessment. Any further specifications of an envisioned TranSTEP process are currently hard to make, given the indicated situation of synthetic biology governance in Germany which appears particular unclear and open for diverse directions of future development. This certainly is also due to the very early and immature developmental stage of the technology itself.

Parts of this text have already been published in van Doren, Davy; Heyen, Nils B. (2014): Synthetic biology: Too early for assessments? A review of synthetic biology assessments in Germany. In: Science and Public Policy 41 (3), 272-282.