Abstract
Synthetic biology (SB) is rather a new field of science and technology. Societal, regulatory, legal, ethical, safety and security aspects of this field have already been analysed in much detail and discussed very widely in recent years. There is, however, a dearth of empirical studies on the points of view of relevant stakeholders in countries where SB is still in the process of emergence. Slovenia is one of them, and accordingly, the article analyses the situation of SB in this small country, focusing on the points of view of various stakeholder groups concerning three aspects of SB: the policy framework, the ethical-legal discourse and the issues of biosafety and biosecurity. It is argued that Slovenia has missed many opportunities to foster the domestic development of the field; in particular, considering that at an early stage, young Slovenian researchers participated very successfully in the International Genetically Engineered Machine (iGEM) competition.
Similar content being viewed by others
Notes
The success of iGEM teams could be one reason that the share of the Slovenian public that is familiar with SB is quite large. The last Eurobarometer survey of public opinion about new technologies showed that 22% of respondents in Slovenia had already heard of SB. For example, quite similar shares are found in the UK (21%), the Netherlands (20%) and Germany (18%) [34].
In Slovenia, there exist some bioinformatics companies that deal with genomics data analysis and visualisation consulting services and software products in biogenomic science. One such firm is ‘Genialis’ which focuses on the development of web applications that enable exploratory analysis of next-generation sequencing and microarray data and target gene prioritisation using various machine learning approaches. ‘Genialis’ was founded in 2013 as a spin-off from the Biolab (Bioinformatics laboratory) at the Faculty of Computer and Information Sciences of the University of Ljubljana. Another relevant SME is the ‘Metagenomic Centre’ which concentrates on applied (meta)genomics, cell-abiotic surface and cell-biotic surface interactions within the study of bioaerosols.
A get-and-give philosophy underpins the Registry of Standard Biological Parts. The Registry is part of the iGEM Foundation [33]. It is a continuously growing community collection of biological parts that can be mixed and matched to build synthetic biology devices and systems. The Registry provides these resources for the continued growth of SB in education, academic research and new industry.
References
Capurro R, Kinderlerer J, da Silva P, Rosell P (2010) Ethics of synthetic biology. Opinion of the European Group on Ethics in Ecience and New Technologies to the European Commission. No. 25. Publications Office of the European Union, Luxembourg. https://doi.org/10.2796/10789
Van den Belt H (2013) Synthetic biology, patenting, health and global justice. Syst Synth Biol 7(3):87–98. https://doi.org/10.1007/s11693-012-9098-7
Jing L, Yunzi L, Huimin Z (2011) Synthetic biology: putting synthesis into biology. Wires Syst Biol Med 3(1):7–20. https://doi.org/10.1002/wsbm.104
Zhang J (2013) The art of trans-boundary governance: the case of synthetic biology. Syst Synth Biol 7(3):107–114. https://doi.org/10.1007/s11693-012-9097-8
Schyfter Camacho P, Frow E, Calvert J (2013) Synthetic biology: making biology into an engineering discipline. Eng Stud 5(1):1–5. https://doi.org/10.1080/19378629.2013.763647
Endy D (2005) Foundations for engineering biology. Nature 438(24):449–453. https://doi.org/10.1038/nature04342
Andrianantoandro E, Basu S, Karig D, Weiss R (2006) Synthetic biology: new engineering rules for an emerging discipline. Mol Syst Biol 2. https://doi.org/10.1038/msb4100073
Bhutkar A (2005) Synthetic biology. Navigating the challenges ahead. J Biolaw Bus 8(2):1–11
Porcar M (2016) Synthetic biology: from having fun to jumping the gun. NanoEthics 10(1):105–109. https://doi.org/10.1007/s11569-016-0251-8
Deplazes-Zemp A, Gregorowius D, Biller-Andorno N (2015) Different understandings of life as an opportunity to enrich the debate about synthetic biology. NanoEthics 9(2):179–188. https://doi.org/10.1007/s11569-015-0226-1
Ancillotti M, Rerimassie V, Seitz T, Steurer W (2016) An update of public perceptions of synthetic biology: still undecided? NanoEthics 10(3):309–325. https://doi.org/10.1007/s11569-016-0256-3
Frank D, Heil R, Coenen C, König H (2015) Synthetic biology’s self-fulfilling prophecy—dangers of confinement from within and outside. Biotechnol J 10(2):231–235. https://doi.org/10.1002/biot.201400477
Kuhlmann S, Rip A (2014) The challenge of addressing grand challenges—A think piece on how innovation can be driven towards the “grand challenges” as defined under the prospective European Union Framework Programme Horizon 2020. University of Twente. https://ec.europa.eu/research/innovation-union/pdf/expert groups/The_challenge_of_addressing_Grand_Challenges.pdf. Accessed 24 March 2017
Von Schomberg R (2013) A vision of responsible innovation. In: Owen R, Heintz M, Bessant J (eds) Responsible innovation. John Wiley, London, pp 51–74. https://doi.org/10.1002/9781118551424.ch3
Mali F, Pustovrh T, Groboljsek B, Coenen C (2012) National ethics advisory bodies in the emerging landscape of responsible research and innovation. NanoEthics 6(3):167–184. https://doi.org/10.1007/s11569-012-0157-z
Ahvenharju S, Halonen M, Uusitalo S, Launis V, Hjelt M (2006) Comparative analysis of opinions produced by national ethics councils. Final report. Gaia Group Ltd., Helsinki
Fuchs M (2005) Nationale Ethikräte. Hintergründe, Funktionen und Arbeitsweisen im Vergleich. Nationaler Ethikrat, Berlin
Pustovrh T, Mali F (2015) (Bio)ethicists and (bio)ethical expertise in national ethical advisory bodies: roles, functions and perceptions. Prolegomena 14(1):47–69. https://doi.org/10.1080/23311886.2016.1143599
Von Schomberg R (2011) Prospects for technology assessment in a framework of responsible research and innovation. In: Dusseldorp M, Beecroft R (eds) Technikfolgen abschätzen lehren: Bildungspotenziale transdisziplinärer Methode. Springer VS, Wiesbaden, pp 39–61
Whitman J (2006) Governance challenges of technological systems convergence. Bull Sci Technol Soc 26(5):398–409. https://doi.org/10.1177/0270467606292507
Fisher E, Mahajan R, Mitcham C (2006) Midstream modulation of technology: governance from within. Bull Sci Technol Soc 26(6):485–496. https://doi.org/10.1177/0270467606295402
Bainbridge W, Roco M (Eds.) (2002) Converging technologies for improving human performance: nanotechnology, biotechnology, information technology and cognitive science. NSF/DOC-sponsored report. Kluwer Academic Publishers, Dordrecht. http://www.wtec.org/ConvergingTechnologies/Report/NBIC_report.pdf. Accessed 11. November 2017
De Vriend H (2006) Constructing life. Early social reflections on the emerging field of synthetic biology. Rathenau Institute, The Hague. https://www.rathenau.nl/en/file/2290/download?token=Vpy4NFFK. Accessed 21 Nov 2017
Wolbring G (2008) Why NBIC? Why human performance enhancement? Innovation 21(1):25–40. https://doi.org/10.1080/13511610802002189
Coenen C (2009) Zauberwort Konvergenz. Technikfolgenabschätzung. Theorie und Praxis 18(2): 44–50. https://www.tatup-journal.de/downloads/2009/tatup092_coen09a.pdf. Accessed 19 Nov 2017
Endy D (2014) Introduction. How would you design nature? In: Endy D, Ginsberg A, Calvert J, Schyfter P, Elfick A (eds) Synthetic aesthetics. Investigating synthetic biology’s designs on nature. The MIT Press, Cambridge, pp 7–22
Porcar M, Pereto J (2012) Are we doing synthetic biology? Syst Synth Biol 6(3–4):79–83. https://doi.org/10.1007/s11693-012-9101-3
Pollack A. (2016) Scientists talk privately about creating a synthetic human genome. Science, 13 May 2016
Industrialization of Biology (2015) Committee on industrialization of biology: a roadmap to accelerate the advanced manufacturing of chemicals. The National Academic Press, Washington
Zhang J, Marris C, Rose N (2011) The transnational governance of synthetic biology. Scientific uncertainty, cross-borderness and the ‘art’ of governance. BIOS Working paper No. 4. London School of Economics and Political Science: BIOS (Center for the Study of Bioscience, Biomedicine, Biotechnology and Society). https://www.kcl.ac.uk/sspp/departments/sshm/people/academic/marris/TransnationalGovernanceSynBio2011.pdf. Accessed 13 May 2016
OECD (2014) Emerging policy issues in synthetic biology. OECD Publishing. http://www.oecd-ilibrary.org/science-and-technology/emerging-policy-issues-in-synthetic-biology_9789264208421-en. Accessed 5 Apr 2016
Synthetic Biology in Denmark (2012) ERA SynBio newsletter, July 2012. http://www.erasynbio.eu/lw_resource/datapool/_items/item_30/erasynbio_nl1_july2012_final.pdf. Accessed 22 Apr 2016
iGEM (2017) Synthetic biology. iGEM competition. http://igem.org/Main_Page. Accessed 22 Nov 2017
Eurobarometer (2010) Europeans and biotechnology in 2010. Winds of change? A report to the European Commission’s Directorate-General for Research. Publications Office of the European Union, Luxembourg
Goodman C (2008) Engineering ingenuity at iGEM. Nat Chem Biol 4(1):13. https://doi.org/10.1038/nchembio0108-13
Church G, Regis E (2012) Regenesis. How synthetic biology will reinvent nature and ourselves. Basic Books, New York
iGEM (2007) iGEM ‘Teach the teachers’ workshop at TJU. http://2007.igem.org/wiki/index.php/TTT_2007:China. Accessed 23 Nov 2017
SICRIS (2015) Slovenian Current Research Information System. Maribor: Institute for Information Science. http://www.sicris.si/public/jqm/cris.aspx?lang=eng&opdescr=home. Accessed 10 Apr 2016
Kronegger L, Mali F, Ferligoj A, Doreian P (2015) Classifying scientific disciplines in Slovenia: A study of the evolution of collaboration structures. J Assoc Inf Sci Tech 66(2):321–339. https://doi.org/10.1002/asi.23171
Mali F (2010) Turning science transdisciplinary: is it possible for the new concept of cross-disciplinary cooperations to enter Slovenian science and policy? In: Kajfez-Bogataj L et al (eds) Modern RISCsocieties: towards a new paradigm for societal evolution. Echoraum, Vienna, pp 461–474
EN-FIST (2016) EN-FIST centre of excellence. R&D Projects. http://enfist.si/En/. Accessed 25 Apr 2016
Calvert J, Martin P (2009) The role of social scientists in synthetic biology. EMBO Rep 10(3):201–204. https://doi.org/10.1038/embor.2009.15
Patton M (2015) Qualitative research & evaluation methods: integrating theory and practice. Sage Publications Inc, London
Douglas C, Stemerding D (2014) Challenges for the European governance of synthetic biology for human health. Life Sci Soc Policy Dec 10:6. https://doi.org/10.1186/s40504-014-0006-7
Ganguli-Mitra A, Schmidt M, Torgersen H, Deplazes A, Biller-Andorno N (2009) Of Newtons and heretics. Nat Biotech 27(4):321–322. https://doi.org/10.1038/nbt0409-321
O’Malley M, Powell A, Davies J, Calvert J (2008) Knowledge-making distinctions in synthetic biology. BioEssays 30(1):57–65. https://doi.org/10.1002/bies.20323
Arkin A, Greenwood J, Wendell L (2009) What’s in a name? Nat Biotechnol 27(12):1071–1073. https://doi.org/10.1038/nbt1209-1071
UK Roadmap (2012) A synthetic biology roadmap for the UK. Published by Technology Strategy Board on behalf of UK Synthetic Biology Roadmap Coordination Group. http://www.rcuk.ac.uk/documents/publications/syntheticbiologyroadmap-pdf. Accessed 11 Apr 2016
European Commission (2012) Innovating for sustainable growth: A bioeconomy for Europe. Communication from the commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Brussels 13.2.2012 COM (2012) 60 final. http://ec.europa.eu/research/bioeconomy/pdf/201202_innovating_sustainable_growth_en.pdf. Accessed 11 May 2017
Slovenian Research Agency (2015) News. Informations (Novice. Obvestila). https://www.arrs.gov.si/sl/obvestila/15/upadanje-sredstev-za-znanost.asp. Accessed 17 Apr 2016
Boyle, J (2010) Monopolists of genetic code? Financial Times, 27 May 2010. https://www.ft.com/content/4883637c-69d7-11df-8432-00144feab49a. Accessed 18 Nov 2017
Mali F (2004) Recent dilemmas in the social and legal regulation of biotechnology in the European Union. Vest – J Sci Tech Stud 17(3–4):39–60
European Biotechnological Directive (1998) Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. http://www.wipo.int/wipolex/en/details.jsp?id=1440. Accessed 20 Nov 2017
Official Gazette RS (2003) Decree on the legal protection of biotechnological inventions, Official Gazette RS, No 81/2003; http://www.uil-sipo.si/sipo/addition/resources/legislation/legislation-slovenia/. Accessed 19 Nov 2017
Jasanoff S (2007) Design on nature. Princeton University Press, Princeton
Radder H (2004) Exploiting abstract possibilities: a critique of the concept and the practice of product patenting. J Agric Environ Ethics 17(2):275–291. https://doi.org/10.1023/B:JAGE.0000033080.99746.da
Kevels J (2002) Of mice and money: the story of the world’s first animal patent. Daedalus 131(2):78–88
Oye K, Wellhausen R (2010) The intellectual commons and property in synthetic biology. In: Schmidt M, Ganguli-Mitra A, Huib V (eds) Synthetic biology: the technoscience and its societal consequences. Springer, Heidelberg, pp 121–140
Calvert J (2010) Synthetic biology: constructing nature? In: Parry S, Dupre J (eds) Nature after the genome. Wiley Blackwell, Oxford, pp 95–113
Calvert J (2008) The commodification of emergence: systems biology, synthetic biology and intellectual property. BioSocieties 3(4):383–398. https://doi.org/10.1017/S1745855208006303
Frow E (2015) Rhetorics and practices of democratization in synthetic biology. In: Wienroth M, Rodrigues E (eds) Knowing new biotechnologies. Social aspects of technological convergence. Routledge, pp 174–189
Frow E, Calvert J (2013) Opening up the future(s) of synthetic biology. Futures 48(April):32–43. https://doi.org/10.1016/j.futures.2013.03.001
Calvert J (2012) Ownership and sharing in synthetic biology: a ‘diverse ecology’ of the open and the proprietary? BioSocieties 7(2):169–187. https://doi.org/10.1057/biosoc.2012.3
European Commission (2015) Opinion on synthetic biology II. Risk assessment methodologies and safety aspects. The SCENIHR at their plenary on 29 April 2015, the SCHER and the SCCS by written procedure on 4 May 2015. European Union, 2015. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_048.pdf. Accessed 15 May 2016
Funding
This article was written with the support of the European Commission FP7 Science in Society funded project, Synthetic Biology – Engaging with New and Emerging Science and Technology in Responsible Governance of the Science and Society Relationship (SYNERGENE).
Author information
Authors and Affiliations
Corresponding author
Additional information
The interviews were conducted by the author and Dr Toni Pustovrh (†) from the Centre for Social Studies of Sciences at the Faculty of Social Sciences (University of Ljubljana).
Rights and permissions
About this article
Cite this article
Mali, F. How to Address the Policy and Ethical Issues Emerging with New Technology. The Case of Synthetic Biology in a Small Country. Nanoethics 12, 61–73 (2018). https://doi.org/10.1007/s11569-017-0310-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11569-017-0310-9