Skip to main content
SpringerLink
Log in

Synthetic Biology: Challenges and Legal Questions

  • Chapter
  • First Online:
Synbio and Human Health

Abstract

“Synthetic biology – birth of a new technology.” Under this label, the discussion on synthetic biology is conducted. But what is really new about the synthetic biology? Not much! 95–98 % of what is declared as Synthetic Biology is just a direct continuation of modern molecular biology, genetic research or genetic engineering. For these technologies the existing laws, especially the Gene Technology Law is applicable. Irrespective of this, various ethical, social and legal fields of conflict are discussed with respect to Synthetic Biology, particularly with regard to its implementation orientation, the enormous scientific progress and the sizeable (concrete) application potential. This discussion is focused on aspects of safety, security and justice/fairness. Stronger security measures with regard to the potential misuse seem to be needed. Freedom of research could be restricted as the international debate on the H5N1 virus has shown recently. For example, a Global Health Security Policy Board is under discussion. On the other hand, several national and supranational organizations come to the result that a strict regulation of Synthetic Biology would do more harm than good. Their result is to observe the developments of Synthetic Biology and to react flexible. This paper provides an overview about the German debate in the international context.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    Eurobarometer 73.1 Biotechnologie (2010) – Bericht zur Befragung zur Biotechnologie, in: Eurobarometer Spezial 328, p. 142.

  2. 2.

    Hohlfeld, R. (<CitationRef CitationID="CR20” >1988</Citation Ref>), Biologie als Ingenieurskunst. Zur Dialektik von Naturbeherrschung und synthetischer Biologie, in: Ästhetik und Kommunikation 69/1988, p. 61: “In fact today physicists, chemists and molecular biologists using gene technology, chemical and biochemical synthesis methods and highly advanced automation techniques can construct biological agents, genes, cell-like membrane vesicles and organisms with a completely new genetic map, which nature has never seen before.”; Eberbach, Wolfram (<CitationRef CitationID="CR11” >2012</Citation Ref>), Gentechnik und Recht, in: Eberbach et al., “Recht der Gentechnik und Biomedizin”, 79. Erg.Lieferung, Band 1, Teil A. I. p. 13 (12) refering to the historical discussion of the risks of gentechnologie.

  3. 3.

    http://syntheticbiology.org/Who_we_are.html

  4. 4.

    Dritter Bericht der Bundesregierung über Erfahrungen mit dem Gentechnikgesetz (<CitationRef CitationID="CR16” >2008</Citation Ref>): Bt-Drs 16/8155, printed in: Eberbach et al. (2012): Band 2, Teil I, B. I., p. 3.

  5. 5.

    It seems possible to achieve this result by interpretation of the law or by a decision of the ZKBS, in the same way the ZKBS evaluates new GMO or new forms of genetic engeneering.

  6. 6.

    Futures of artificial life, Nature, Editorial, <CitationRef CitationID="CR14” >2004</Citation Ref>, Vol 431, p. 613.

  7. 7.

    World Health Organization, Statement 30. 11.2011: “WHO concerned that new H5N1 influenza research could undermine the 2011 Pandemic Influenza Preparedness Framework”, www.who.int/entity/…/news/…/index.html

  8. 8.

    Statement of NSABB (<CitationRef CitationID="CR43” >2012</Citation Ref>), Meeting of the National Science Advisory Board for Biosecurity to Review Revised Manuscripts on Transmissibility of A/H5N1 Influenza Virus, oba.od.nih.gov/…/biosecurity/…/NSABB_Statem…(access 27.12.2012)

  9. 9.

    Biotechnology Research in the Age of Terrorism (Fink Report, <CitationRef CitationID="CR2” >2004</Citation Ref>), Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, National Research Council, Washington D.C., www.nap.edu/openbook.php?isbn=0309089778 – (access 27.12.2012).

  10. 10.

    Kraemer, John D/Gostin, Lawrence O. (<CitationRef CitationID="CR24” >2012</Citation Ref>), georgetown Public Law and Legal Theory Research Paper No. 12-020 papers.ssrn.com/sol3/papers.cfm?abstract_id… – (access28.12.2012); The Limits of Government Regulation of Science, Georgetown Medical Center, Office of Communication (2012), Balancing Scientific Freedom and National Security, Two Georgetown professors explore a process needed to avoid the current dilemma faced by two scientific journals recently asked by the U.S. government to redact parts of scientific publications, January 19, explore.georgetown.edu/news/?ID = 61756…(access 23.12.2012).

  11. 11.

    “Security and Defense Research” Working Group (<CitationRef CitationID="CR42” >2010</Citation Ref>), Guidelines and Rules of the Max Planck Society On A Responsible Approach To Freedom Of Research And Research Risks, 19. 3., www.mpg.de/232129/researchFreedomRisks.pdf – (access 17.11.2012).

  12. 12.

    “Security and Defense Research” Working Group (<CitationRef CitationID="CR42” >2010</Citation Ref>), pp. 3 f.

  13. 13.

    “Security and Defense Research” Working Group (<CitationRef CitationID="CR42” >2010</Citation Ref>), pp. 6 f.

  14. 14.

    Global Health and Security in Question (ed. Andrew Lakoff/Stephen J. Collier), (2008), New York;

  15. 15.

    International Gene Synthesis Consortium (IGSC), www.genesynthesisconsortium.org.

  16. 16.

    Presidential Commission for the Study of Bioethical Issues (<CitationRef CitationID="CR31” >2010</Citation Ref>), New Directions. The Ethics of Synthetic Biology and Emerging Technologies, Washington, pp. 140 ff.

  17. 17.

    Ibid., pp. 147 ff.

  18. 18.

    Ibid., pp. 115 ff.

  19. 19.

    Bt-Ds 17/5165, p. 5; the same position has the scientific service of the German Parliament, Donner, Susanne et al., Statement of the scientific service of the German Parliament (2009) Nr. 60/09.

  20. 20.

    Antwort der Bundesregierung v. 22.03.2011 (Bt-Drs: 17/5165); Luttermann, JZ 2011, p.195; Deutscher Ethikrat (Friedrich, Bärbel v. 24.01.2010); Wiss. Dienst d. BT r. 60/09 v. 15.07.2009; Parl. Ethikbeirat v. 01.07.2009, 16/13780; Sauter, Tab-Bericht 2011; Pühler, Alfred, Tagesspiegel v. 23.02.2011

  21. 21.

    Gen-ethisches Netzwerk e.V.

  22. 22.

    Bund für Umwelt- und Naturschutz Deutschland e. V.

  23. 23.

    BVerfG (2011), ibid.

  24. 24.

    BVerfG (2011), ibid.

  25. 25.

    Com.. BVerfGE 47, 327 (369); 57, 70 (99).

  26. 26.

    Com. BverfGE 83, 130 (142); 107, 104 (120); 122, 89 (107).

  27. 27.

    Com. BverfGE 47, 327 (369); 122, 89 (107).

  28. 28.

    Bt-Ds 17/5165, p. 5.

References

  • Balmer A, Martin P (2008) Synthetic biology: social and ethical challenges. Institute for Science and Society/University of Nottingham, Nottingham, p 15

    Google Scholar 

  • Biotechnology Research in the Age of Terrorism (Fink Report, 2004) Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, National Research Council, Washington D.C., www.nap.edu/openbook.php?isbn=0309089778. Accessed 27 Dec 2012

  • Boldt J et al (2009) Synthetische Biologie – eine ethisch-philosophische Analyse. Bern, Bundesamt für Bauten und Logistik, p 8, mentis verlag Paderborn 2012

    Google Scholar 

  • Catenhusen W-M (2011) In: Simultanmitschrift der Tagung des Deutschen Ethikrat vom 23.11.2011, p 85 Mannheim, www.ethikrat.org/dateien/pdf/tagung-23-11-2011-simultanmitschrift.pdf

  • Charisius H et al (2012) Unser kleines Gen-Labor, http://www.spektrum.de/alias/biotechnologie/unser-kleines-gen-labor/1153300

  • Cohen J (2012) WHO Group: H5N1 papers should be published in full. Science 335(6071):899–900. doi:10.1126/science.335.6071.899, 24 February 2012

    Article  CAS  PubMed  Google Scholar 

  • DECHEMA (2011) Biotechnologie Arbeitskreis systembiologische und synthetische Biologie, Thesenpapier zum Stand der Synthetischen Biologie in Deutschland, pp 11

    Google Scholar 

  • Dederer HG (2010) Neuartige Technologien als Herausforderung an das Recht – dargestellt am Beispiel der Nanotechnologie. In: Spranger T (ed) Aktuelle Herausforderungen der Life Sciences. Münster, Berlin, LIT Verlag, p 71 f

    Google Scholar 

  • Deutscher Ethikrat Friedrich, B (2010) cited in “Leben aus dem Baukasten” Pressebericht in Deutscher Ethikrat Infobrief 01/2010, 4-5, Deutscher Ethikrat, Berlin

    Google Scholar 

  • Donner S et al (2009) Statement of the scientific service of the German Parliament. Wiss. Dienst d. BT r. 60/09 v. 15.07.2009, Berlin, https://www.bundestag.de/dokumente/analysen/umwelt4

  • Eberbach W (2012) Gentechnik und Recht. In: Eberbach et al. Recht der Gentechnik und Biomedizin, 79. Erg.Lieferung, Band 1, Ebersbach and Lange and Ronellenfitsch, C.F. Müller, Heidelberg, München, Landsberg, Frechen, Hamburg, Loose-leaf collection Teil A. I. pp 13 (12)

    Google Scholar 

  • Engelhardt M (2010) Die Politische Meinung Nr. 493, pp 23 (17)

    Google Scholar 

  • Fouchier RA (2012) Airborne transmission of influenza A/H5N1 virus between ferrets. Science 336(6088):1534–41

    Article  PubMed  Google Scholar 

  • Futures of artificial life, Nature, Editorial, 2004, vol 431, pp 613. Nature publishing group, www.nature.com/nature/journal/v431/n7009/full/431613b.html

  • Garfinkel MS, Endy D, Epstein GL, Friedmann RM (2007) Synthetic genomics: options for governance. The J Craig Venter Insitute, Rockville, p 38, ff

    Google Scholar 

  • Dritter Bericht der Bundesregierung über Erfahrungen mit dem Gentechnikgesetz (2008) Bt-Drs 16/8155, printed. F. Müller, Heidelberg, München Landsberg, Frechen, Hamburg, Loose-leaf collection also: http://www.dip21.bundestag.de/dip21/btd/16/0891/1608/1608155.pdf In: Eberbach et al. (2012): Band 2, Teil I, B. I., p 3

  • Herdegen M (5. Erg. Lfg. 1992) In: Eberbach et al. Recht der Gentechnik und Biomedizin (2012), Band 1, Teil I, Einl. GentG, p 11 m. w. Nw

    Google Scholar 

  • Herdegen (2012) C.F. Müller, Heidelberg, München, Landsberg, Frechen, Hamburg, Loose-leaf collection

    Google Scholar 

  • Hohlfeld R (1984) Der Mensch als Objekt von Biotechnologie und biomedizinischer Forschung. In: Gewerkschaftliche Monatshefte 35, Bund-Verlag, Frankfurt/M, pp 594–596

    Google Scholar 

  • Hohlfeld R (1986) “Die zweite Schöpfung des Menschen”. In: Gewerkschaftliche Monatshefte 9, Bund-Verlag, Frankfurt/M, pp 550–560

    Google Scholar 

  • Hohlfeld R (1988) Biologie als Ingenieurskunst. Zur Dialektik von Naturbeherrschung und synthetischer Biologie. In: Ästhetik und Kommunikation e. V. 69/1988, Berlin, p 61

    Google Scholar 

  • Hohlfeld R (1990) Synthetische Biologie – Biologie als Ingenieurskunst. In: Grosch K, Peter H Herstellung der Natur? – Stellungnahmen zum Bericht der Enquete-Kommission “Chancen und Risiken der Gentechnologie”), Campus-Verlag, Frankfurt/M and New York

    Google Scholar 

  • International Gene Synthesis Consortium (IGSC) www.genesynthesisconsortium.org

  • Kawaoka Y et al (2012) Experimental adaptation of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets. Nature 485:13–14, (02 May 2012), published online

    Article  Google Scholar 

  • Kraemer JD, Gostin LO (2012) Georgetown Public Law and Legal Theory Research Paper No. 12-020 papers.ssrn.com/sol3/papers.cfm?abstract_id… – (access28.12.2012); The Limits of Government Regulation of Science, Georgetown Medical Center, Office of Communication (2012), Balancing Scientific Freedom and National Security, Two Georgetown professors explore a process needed to avoid the current dilemma faced by two scientific journals recently asked by the U.S. government to redact parts of scientific publications, January 19, explore.georgetown.edu/news/?ID=61756…Accessed 23 Dec 2012

    Google Scholar 

  • Kupferschmidt K (2011) Mit den Waffen der Wissenschaft Vogelgrippevirus NSABB Forschungsfreiheit, Der Tagespiegel, 31 Nov 2011. www.markusschmidt.eu/?page_id=20

  • Lengeler J (1988) Die methodischen Grundlagen der modernen Gentechniken. In: Gentechniken und Individum, C. Heymanns, pp 17

    Google Scholar 

  • Luttermann C (2011) Synthetische Biologie: Bausteine für Leben und Jurisprudenz, JZ 2011, Mohr Siebeck, Tübingen, pp 195 f

    Google Scholar 

  • Mooney P (2010) Next Bang! Wie das riskante Spiel mit Megatechnologien unsere Existenz bedroht. Oekom, München, p 118

    Google Scholar 

  • Müller-Röber B (2011) In: Simultanmitschrift der Tagung des Deutschen Ethikrat vom 23 Nov 2011, pp 70 Mannheim, www.ethikrat.org/dateien/pdf/tagung-23-11-2011-simultanmitschrift.pdf

  • Nouri A, Chyba CF (2009) Proliferation-resistant biotechnology: an approach to improve biological security. Nat Biotechnol 27:234–236

    Article  CAS  PubMed  Google Scholar 

  • Presidential Commission for the Study of Bioethical Issues (2010) New Directions. The Ethics of Synthetic Biology and Emerging Technologies. Washington, DC, pp 140 ff

    Google Scholar 

  • Ronellenfitsch M (2004) In: Eberbach (2012) “Recht der Gentechnik und Biomedizin”, Band 1, Teil I, B. I. § 3 GenTG, p 22 f. C.F.Müller, Heidelberg, München, Landsberg, Frechen, Hamburg, Loose-leaf collection

    Google Scholar 

  • Ronellenfitsch M (2008) In: Eberbach et al Recht der Gentechnik und Biomedizin (2012), Band 1, Teil I, B.I., p 17

    Google Scholar 

  • Sauter A (2011) Synthetische Biologie: Finale Technisierung des Lebens – oder Etikettenschwindel. In: TAB-Brief Nr. 39, edition-sigma, Berlin, pp 23

    Google Scholar 

  • Sauter, Tab-Bericht (2011) Pühler, Alfred, Tagesspiegel v. 23 Feb 2011

    Google Scholar 

  • Schmidt (2011) p. 120; Wagner. In: Simultanmitschrift der Tagung des Deutschen Ethikrat vom 23 Nov 2011, p 81; Engelhard (2010), p 22

    Google Scholar 

  • Schmidt M (2011) Biosicherheit und Synthetische Biologie. In: Pühler A (ed) Synthetische Biologie – Die Geburt einer Technikwissenschaft, acatech, Springer-Verlag, Berlin Heidelberg, pp 112 f. (111)

    Google Scholar 

  • Schmidt M, Giersch G (2011) DNA synthesis and security. In: Campbell MJ (ed) DNA microarrays, synthesis and synthetic DNA, Chapter 6, M Schmidt, G Giersch - markusschmidt.eu. Accessed 19 Dec 2012 Nova Publishers, www.markusschmidt.eu/?page_id=20

  • Schultz N (2009) Perspektivenpapier Synthetische Biologie, http://www.ethikrat.org/der_files/Perspektivenpapier_Synthetische_Biologie_2009-04-23.pdf; DFG Synthetische Biologie

  • Schummer J (2011) Das Gotteshandwerk. Die künstliche Herstellung von Leben im Labor. Suhrkamp, Berlin, p 111

    Google Scholar 

  • Schwille P (2011) In: Simultanmitschrift der Tagung des Deutschen Ethikrat vom 23.11.2011 workshop life. The significance of synthetic biology for science and society, pp 5. Mannheim, www.ethikrat.org/dateien/pdf/tagung-23-11-2011-simultanmitschrift.pdf

  • “Security and Defense Research” Working Group (2010) Guidelines and rules of the Max Planck Society on a responsible approach to freedom of research and research risks, 19. 3. www.mpg.de/232129/researchFreedomRisks.pdf. Accessed 17 Nov 2012

  • Statement of NSABB (2012) Meeting of the National Science Advisory Board for Biosecurity to Review Revised Manuscripts on Transmissibility of A/H5N1 Influenza Virus, oba.od.nih.gov/…/biosecurity/…/NSABB_Statem…Accessed 27 Dec 2012

    Google Scholar 

  • Stegemann R (2011) In: Simultanmitschrift der Tagung des Deutschen Ethikrat vom 23.11.2011, pp 14 Mannheim, www.ethikrat.org/dateien/pdf/tagung-23-11-2011-simultanmitschrift.pdf

  • The European Group on Ethics in Science and New Technologies to the European Commission (cit. EGE) (2009) Ethics of synthetic biology, Opinion no. 25, Brussels, 17 Nov, pp 27 f

    Google Scholar 

  • Then C (2010) Pressemitteilung von TestBiotech e.V. vom 15 June 2010, http://www.testbiotech.de/pressearchiv?page=4

  • Then C, Hamberger S (2010) Synthetische Biologie, Teil 1: Synthetische Biologie und künstliches Leben –eine kritische Analyse, Testbiotech, München, testbiotech e. V., pp 21 https://www.testbiotech.org/synthetische-biologie

  • Wiss. Dienst d. BT r. 60/09 v. 15.07.2009; Parl. Ethikbeirat v. 01.07.2009, 16/13780

    Google Scholar 

  • World Health Organization, Statement (2011) WHO concerned that new H5N1 influenza research could undermine the 2011 Pandemic Influenza Preparedness Framework. www.who.int/mediacentre/news/statements/2011/pip_framework_20111229/en/index.html

  • Zelder O (2011) In: Simultanmitschrift der Tagung des Deutschen Ethikrat vom 23 Nov 2011, pp 15

    Google Scholar 

  • Zwischenbericht der Zentralen Kommission für die Biologische Sicherhei- (cit: ZKBS) (2012) Monitoring der Synthetischen Biologie in Deutschland, p 8, accessed at: http://www.bvl.bund.de/DE/06_Gentechnik/03_Antragsteller/06_Institutionen_fuer_biologische_Sicherheit/01_ZKBS/01_Allg_Stellungnahmen/01_allgemeineThemen/zkbs_allgemeineThemen_node.html

Download references

Author information

Authors and Affiliations

  1. Centre for Ethics and Law in the Life Sciences (CELLS), Medical University Hannover, Hannover, Germany

    Jürgen Robienski & Jürgen Simon

Authors
  1. Jürgen Robienski
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jürgen Simon
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Jürgen Robienski .

Editor information

Editors and Affiliations

  1. University of the Basque Country UPV/EHU, Bilbao, Vizcaya, Spain

    Iñigo de Miguel Beriain

  2. University of the Basque Country UPV/EHU, Bilbao, Spain

    Carlos María Romeo Casabona

Rights and permissions

Reprints and permissions

Copyright information

© 2014 Springer Science+Business Media Dordrecht

About this chapter

Cite this chapter

Robienski, J., Simon, J. (2014). Synthetic Biology: Challenges and Legal Questions. In: de Miguel Beriain, I., Romeo Casabona, C. (eds) Synbio and Human Health. Springer, Dordrecht. https://doi.org/10.1007/978-94-017-9196-0_9

Download citation

Publish with us

Policies and ethics

Search

Navigation