Science, Technology and the State: Implications for Governance of Synthetic Biology and Emerging Technologies

Abstract

New biological systems and organisms designed to satisfy human needs are the main goals of the emerging field of synthetic biology. While the technology could solve pressing environmental and health issues, concerns about ecological, security or socio-economic risks were raised. Here, we point to interrelations of science, technology development and the state. These may undermine the emergence of innovation and safety cultures required to foster new opportunities and to responsibly govern potential transformations linked to synthetic biology and other emerging technologies.

Programmatic concepts for constructing technologies appear to be the results of these interrelations rather than solutions to the challenges they cause. We propose the need for cultures that can stimulate experimentation and evolution of these technologies in ways beneficial to society, guided by overriding ethical values. This concept also includes an explorative political culture.

Introduction

Synthetic biology does not constitute a strictly defined field but may be best described as an engineering approach aimed at redesigning or newly constructing biology-derived ‘parts’, systems and entire organisms. It integrates different disciplines and knowledge derived from molecular biology, chemistry, mathematical modelling and computer-aided design, as well as the concept of generating and using interchangeable ‘biological parts’, which is often seen as the hallmark of synthetic biology (NBT 2009). Hopes regarding societal benefits linked to synthetic biology include chemicals and new generations of biofuels from renewable sources with lower greenhouse-gas emissions (McEwen/Atsumi 2012; Robertson et al. 2011), new therapies for diseases (Weber/Fussenegger 2012) and novel and rapidly deployable vaccines (Kindsmuller/Wagner 2011) – all of which could contribute to a potential bioeconomical revolution (OECD 2009). On the other hand, potential risks for human health or the environment (biosafety), dual-use issues (biosecurity) and socioeconomic risks (e.g. food and water security, land ‘grab‘) were pointed out (Buyx/Tait 2011; Dana et al. 2012; ETCgroup 2007; UNICRI 2012). Furthermore, ethical and other philosophical concerns about the effects of synthetic biology on the notions of life have been discussed (Boldt/Muller 2008). Against this backdrop, we have sought to identify conditions and potential schemes for governance in synthetic biology that may contribute to knowledge-based policy-making. We started to map potential societal benefits and risks of synthetic biology and to delineate dimensions of these benefits and risks (König et al. 2013). Given the various layers of issues identified as well as the uncertainty and unpredictability regarding the exact nature of innovations and economic developments arising from an emerging field, we have argued that policies need to be informed by the most pluralistic expertise and perspectives available (König et al. 2013).

We propose here that even if conditions could be created under which it would be possible to obtain appropriate pluralistic input of this type, mere policy-informing schemes would not suffice. For there may be fundamental challenges underlying relations between science, technology development and the state that have the potential to undermine efficient knowledge-based policy output. These challenges, and the uncertainties associated with nascent technologies, lead us to postulate the need for exploration-based governance cultures. These should drive evolutionary change in a manner beneficial to society by a framework of overriding societal aims and ethical values.

Dimensions of Benefits and Risks

We previously mapped evidence and arguments to synthetic biology approaches, to biotechnological and biomedical applications as well as to their possible benefits and risks.¹ The work suggests a broad spectrum of approaches connected with synthetic biology concepts. These range from simple genetic circuitries to the assembly of novel metabolic pathways or synthesized viral genomes. Furthermore, they can be a part of different application schemes, including the production of chemicals in closed systems by genetically engineered microorganisms (GEMs); approaches involving the release of GEMs; or the use of genome synthesis to generate viral vaccines (Khalil/Collins 2010; König et al. 2013).

In keeping with these diversities, the actual benefits and risks appear to depend on issues linked to different layers (König et al. 2013). Thus, general aspects of application schemes can matter rather than issues directly related to synthetic biology. These include possible negative impacts on biodiversity or water and food security caused by the planting of energy crops as feedstock for the conversion to biofuels or chemicals by GEMs. Though these aspects are not qualitatively new, a more lucrative conversion to biofuels by “synthetic” organisms may greatly increase the scale of the planting of energy crops and aggravate these problems. Likewise, broad patents and patent thickets, which may increase in number due to synthetic biology (Rutz 2009), are not a completely new phenomenon - they are already known from the biopharmaceutical industry (van Zimmeren et al. 2011). In addition to these rather ‘general’ issues, there are issues more specifically associated with synthetic biology because of its potential to increase the degree to which biological systems could be modified - culminating in “completely synthetic” organisms in the future. This may result in new challenges in the assessment of such organisms with regard to biosafety, since similarities with donor and recipient organisms will become smaller. Furthermore, advances in generating synthetic genes and genomes or in constructing new metabolic pathways might facilitate the generation and the malicious use of (new) pathogens (UNICRI 2012). These developments as well as the possibility that synthesized ‘bioparts’ - and their envisioned straightforward combination into new biological functions via computational design – may make synthetic biology accessible to a broader spectrum of actors (i.e. beyond nationstates), are at the heart of biosecurity concerns linked to synthetic biology (UNICRI 2012).

In addition to these two main dimensions of potential benefits and risks, another aspect that has to be addressed by any governance is synthetic biology’s potential global impact. This may be driven by requirements for large-scale biomass production - a prerequisite for a new transforming bioeconomy - that would have to largely come from the global South, at least if dependent on plant feedstocks (Berndes et al. 2003). Moreover, knowledge, expertise and equipment in biosciences and biotechnology appear to proliferate rapidly (Tucker 2011; UNICRI 2012).

Finally, any assumption about future benefits and risks needs to been seen in the light of high uncertainty, given the unpredictability of the exact nature of future innovations and applications from emerging fields like synthetic biology.

Getting the Input Right – and Why This May Not Suffice

Given these uncertainties and the various layers of issues underlying the potential benefits and risks, the development of effective governance should benefit from being informed by the most pluralistic expertise and perspectives available. In addition to knowledge from experts on different scientific disciplines, knowledge and perspectives based on dialogue with and participation of all potentially affected actors (including all stakeholders and the public) should be a valuable part of such pluralistic information. Reflecting on and subsequently creating conditions and (infra)structures that can encourage and empower these various actors to participate in such a mutual learning and information-generating process would therefore be vital to this approach.

However, even if the right conditions could be created to obtain appropriate pluralistic input of this type, we propose that this would not be enough to generate the desired efficient policy output. Policies are ultimately determined by a state’s (or a union of states’) political system, including governments, parliaments and regulatory agencies. Shortcomings or failures in political systems can thus be at the heart of inefficient policy output. For instance, these may be linked with insufficient independence of regulatory agencies due to phenomena such as regulatory capture, a process through which agencies are manipulated by special interests they are supposed to control (Bó 2006; Shapiro 2012). Most dramatically, possible consequences for public good have recently been revealed by the official investigation into the disaster of the Fukushima Daiichi power plant (Diet 2012). Regarding synthetic biology development in Europe, it may be worth noting that poor conflict-of-interest management at the European Food Safety Authority (EFSA), including ’revolving doors’ situations (i.e. that regulators come from industry sectors they are supposed to regulate, or end up there), has recently been criticized by civil-society organizations (CEO 2012), the European Court of Auditors and the European Parliament (ECA 2012; EP 2012). The EFSA is a centerpiece of the European Union’s environmental-risk assessments related to feed and food, including genetically modified organisms. Further factors for an inefficient policy output may be economic and financial interests of states and governments. These may be linked to ‘national innovation systems’ and state-supported technology development, including investments in demonstrator plants (OECD 2011) or stakes in companies through government-supported venture capital (Da Rin et al. 2011; Economist 2012). Similarly, state-owned industries can give rise to state actors regulating their ‘own’ ventures (Pargendler 2012; Wooldridge 2012), e.g. in the energy sector, which is expected to harbour big economic potential for synthetic biology (OECD 2009; OECD 2011). Finally, it appears that national bioeconomical and military defence interests have been factors that prevented the adoption of compliance measures in the Biological Weapons Convention (BWC) (Tucker 2010). The BWC would also cover weapons and toxins based on synthetic biology.²

These challenges, possibly inherent to governmental schemes for science and technology development on the national (and supranational) level, are associated with pitfalls that may ultimately interfere with the development of societal benefits from emerging technologies. Such pitfalls include an early emergence of a dominant set of methodologies and technologies, e.g. due to top-down prioritization and support (such as subsidies) for specific approaches or technologies, such as nuclear energy (Morton 2012) or certain biofuels (or biofuel feedstocks) (OECD 2011). Likewise, strategic political interventions to foster specific technology sectors can be susceptible to lobbying and capture, including safety regulations (Diet 2012; Shapiro 2012; Sukhdev 2012a).

Thus, these issues that stem from relationships between state actors, vested interests and technology development could add to the challenges raised by the multiple dimensions of potential benefits and risks outlined above. They need to be taken into account in any knowledge-based governance strategy for synthetic biology and other emerging science and technologies.

Conclusions: Implications for Governance, Responsibility and Technology Assessment

We suggest that there are crucial challenges regarding policy output that are linked to impacts by vested interests from within and outside political systems. These may have the potential to undermine the emergence of innovation and safety cultures that could be most appropriate to solve grand societal challenge - and to responsibly govern potential transformations linked to synthetic biology and other emerging technologies. In view of these political issues and the low predictability of innovations and economic developments (Johnson 2010; Lane 2009; Makridakis et al. 2009), politics-driven and programmatic strategies to ‘construct’ specific research fields, technologies or innovation trajectories may not offer the most appropriate solution. Potentially capture-prone, such strategies might even reach back to reinforce these political issues.

Rather, it might be necessary to build cultures that facilitate and guide an evolution of emerging science and technologies in ways beneficial to society. Corresponding innovation and safety cultures should strive to limit top-down prioritizations of specific sectors, increase creativity and experimentation and allow for an evolution-like process to lead to the most appropriate solutions.³ This process, involving competing pluralistic approaches and perspectives, should be guided by a framework of overriding societal aims and ethical values. The main dimension of responsibility should consist in caring for this framework’s constituents, its responsiveness and its shaping power. It is this (value-based) “responsibility” that should guide experimentation and that would need contributions from various actors. Both empirical data and practitioners’ experience suggest that increased creativity and diverse experimentation - related to both science/technology and services/business models - can increase the probability of breakthrough discoveries and innovations, which could contribute to the solving of grand societal challenges (Azoulay et al. 2011; Fortin/Currie 2013; Isenberg 2013; Khosla 2011). Similarly, safety cultures would be based on broad explorations in risk assessment and management, involving pluralistic approaches, knowledge and perspectives. Prospects to recognize risks and to find possibilities to deal with these in ways acceptable for different societal actors may thus increase [(Stirling 2012) and references therein].

Much of the prerequisites for mobilizing and effectively utilizing the pluralism in approaches, perspectives and knowledge that underlies such cultures will depend on political systems, though. Hence, reflection on and exploration of political deliberation and decision-making processes - and thus political culture – will be an important part of what we would like to call cultures of responsible experimentation (CORE). A critical area for experimentation in politics could be the search for complementary pathways to mitigate shortcomings, linked to political and corporate systems as well as their interrelations that can negatively affect policy output. Such pathways may encompass mechanisms to curb regulatory capture, e.g. by more pluralistic control in selecting members of agencies (including approval ofappointments by the legislature) (Bó 2006) or by increasing agencies’ transparency (ECA 2012; Shapiro 2012). Other mechanisms could rely on proposed measures (including the disclosure of corporate externalities) to allow corporations to compete on the basis of innovations that advance resource conservation and respect social standards. Such measures may also further empower consumers to make responsible and directive choices (Sukhdev 2012a; Sukhdev 2012b). Finally, experimental approaches for a closer coupling of public participation and decision-making processes could be a part of such complementing pathways. An explorative political culture and the implementation of such pathways will likely need various societal actors. Bold and visionary political and business leaders that can inspire peers could play an important role. Ideally, however, such experimental pathways would also produce economic and social benefits for a broad range of individuals in societies; providing stimuli from civil society on governments and other policy-making bodies to implement them.

If vested interests in emerging science and (potential key) technologies and shortcomings of political systems were factors that could significantly affect technology development and its societal impacts, this would also pose a significant challenge for technology assessment (TA). Especially for TA institutions that are a part of governmental science organizations or heavily depend on funding from state actors: TA would have to assess the hands that feed it. Potential dependencies and the danger of an “assessive capture” - under which TA could be potentially affected by the players it is supposed to assess - could undermine the value of TA for public good as well as public trust in TA. Simply excluding these political issues from TA might not be an option though; since it may entail the same consequences. In order to cope with this dilemma, TA and its institutionalization may need more experimentation.

The authors: Dr. Harald König holds a a PhD in biology and works as a scientist at the Institute for Technology Assessment and Systems Analysis at Karlsruhe Institute of Technology. He was organizer of the June 2104 workshop on Synthetic Biology and Responsible Research and Innovation at the Schader-Forum. Daniel Frank and Reinhard Heil are researchers at the Institute for Technology Assessment and Systems Analysis at Karlsruhe Institute of Technology.

This article was published in: Technology Assessment and Policy Areas of Great Transitions. Proceedings from the PACITA 2013 Conference in Prague. Editors: T. Michalek, L. Hebáková, L. Hennen et al. Prague, Technology Centre ASCR.

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