CIBSS – Responsible Science and Technology

Ethical and Legal Approaches for a Responsible Regulation of Signalling Bioscience and Biotechnologies

In the second funding period (starting 2026), we will focus on current developments in biotechnology and bioscience, like the application of New Genomic Techniques and/or AI systems and tools. Those need to be framed by ethical and legal rules. Such rules need to be proportional and linked to the democratic process of law-making at the EU and national levels. In particular, we focus on on the application of AI in biotechnological and biomedical devices, and on the ongoing developments in the (de)regulation of new genomic techniques (NGTs) in the EU. For example, particular attention will be given to the scientifically contentious threshold of 20 genetic modifications in the current EU proposal for a regulation on plants based on certain NGTs, which is considered critical for the comprehensive deregulation of plants obtained through NGTs. In doing so, we will extend the research and results found in CIBSS 1, like the Expert opinion for the Federal Ministery of Federal Ministry of Food and Agriculture about the Compatibility of the EU proposal for a regulation on plants based on certain new genomic techniques with the Cartagena Protocol on Biosafety .

Research during the first funding period (2019 – 2025) focused on the European GMO regulation, its applicability to genome edited plants and, its ethical and international law implications. Starting point for the research was the European Court of Justice (ECJ) judgement from 2018 in the case Confédération paysanne et al (Court of Justice of the European Union, Case C-528/16 – Confédération paysanne and other v Premier ministre and others, Judgment of 25 July 2018) where the ECJ held that organisms whose genetic material has been modified by targeted mutagenesis are subject to the EU Deliberate Release Directive 2001/18. The judgment, its implications and the legal and scientific discussion following its publication were examined. Also, the debate concerning a new regulation for genome edited plants in the EU was analysed. The second half of the first research funding period was built on previous outcomes, especially concerning a future regulation of biotechnology and its foundations. It was based on three pillars:

For the first pillar, the project was built on the previous work and results of the project and continued to analyse from a legal angle the intense debate about the future regulation of biotechnology in the EU and on a global level. Therefore, the various PhD projects adressed the regulation of different aspects of biotechnological research, like the rights of minors parcicipating in clinical trials, or the procedure of marine bioprospecting in light of the New High Seas Treaty. Proposals that have been brought forward in this respect range from keeping, or even tightening the current regulation, to developing a new regulatory framework.

Based on this and as a second pillar, the project aimed to develop proposals on how to regulate biotechnology in the EU and on an international level in an efficient and legitimate way that enables innovation while responsibly framing and reducing related risks. In this context, particular attention was given to critically examining the European Union’s efforts to deregulate modern genomic techniques in plant breeding, for example in an Expert opinion for the Federal Ministery of Federal Ministry of Food and Agriculture about the Compatibility of the EU proposal for a regulation on plants based on certain new genomic techniques with the Cartagena Protocol on Biosafety or a lecture from Constantin Born in the DLF Nova “Hörsaal” Series.

On a global level, human rights can function as an instrument to overcome regulatory gaps in the area of biotechnology, especially since the International Covenant on Civil and Political Rights (ICCPR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR) set internationally legally binding standards. Accordingly, the examination of human rights constituted the third pillar of the project and was of particular significance in a recent contribution (forthcoming in the edited volume International Cooperation under the Human Right to Science), as well as in the aforementioned PhD Projects. Human rights implications on biotechnology and research in this field provide a common basis when developing a legitimate and proportionate regulation, evaluating benefits as well as risks of biotechnological innovations and uncertainties.

CIBSS-1

• Born, Constantin: Die Regulierung des Teilnehmerschutzes im Rahmen klinischer Arzneimittelprüfungen mit Minderjährigen im internationalen, europäischen und nationalen Recht, forthcoming 2026
• Demir, Gizem: Marine Bioprospecting – in Light of the New High Seas Treaty, forthcoming 2026
• Andersen, Elisabeth: Regulation of Biotechnological Risks in a Multi-Level System – An Analysis of the EU Regulation of Genome Edited Plants in light of WTO Law and CETA (forthcoming 2025 – Springer Verlag, European Yearbook of International Economic Law)
• Schreiber, Katharina: Recht und Ethik der Risikoregulierung in der Grünen Gentechnik. Das Vorsorgeprinzip in der Rechtssache C-528/16 Confédération paysanne (University of Freiburg) (published 2023 – Springer Verlag, 420 p.)

Expert opinion for the German Bundestag (TAB): Mögliche Anwendungen von Gene Drives im Vergleich mit alternativen Herangehensweisen, Prof. Dr. Silja Vöneky zusammen mit Dr. Guy Reeves (MPI für Evolutionsbiologie, Plön) et al., 2020-2022

Expert opinion for the Federal Ministery of Federal Ministry of Food and Agriculture, Compatibility of the EU proposal for a regulation on plants based on certain new genomic techniques with the Cartagena Protocol on Biosafety, Prof. Dr. Silja Vöneky, C. Born, L. Tribess and S. Weller, 15.04.2025

• G. Demir, Digitale Sequenzinformationen (DSI) im Rahmen der CBD, BBNJ und COP 16, Doktorantenkolloquium, 29.01.2025
• S. Vöneky, Wie adaptiv ist die Regulierung der grünen Gentechnik?, Lecture as part of the Studium Generale lecture series “Grüne Gentechnik – Chancen für Nachhaltigkeit?”, 04.12.2024, 20 c.t., , 04.12.2024, also available in the ARD-Audiothek and as a video
• C. Born, Moderne Gentechnik – Den Code des Lebens verändern, Lecture in “Hörsaal”-Reihe of Deutschlandfunk Nova, 13.9.2024 
• G. Demir, Digitale Sequenzinformationen unter dem (neuen) UN-Hochseeabkommen, Aktuelle Biodiversitätsforschung (German Federal Agency for Nature Conservation), Insel Vilm, 9-13 September 2024
• S. Vöneky, G. Demir, International Cooperation under the Human Right to Science in light of New Developments in International Law: Human Rights-based Technology Transfer in the Field of Bioprospecting and AI?, University of Fribourg, Switzerland, 5-6 September 2024
• K. Schreiber, European GMO Regulation in Need for Change?, Work in Progress CIBSS, 13.12.2021
• K. Schreiber, The current discussion on gen-edited crops in the EU, Lecture “Environmental and Energy Transition Law”, Freiburg University, 12.01.2021
• E. Andersen, A possible reform of the legal framework for genetically modified organisms in the EU, Work in Progress CIBSS, 30.11.2020
• S. Vöneky, Ethics and Law I: Law and Molecular Biotechnologies, CIBSS Seminar, Freiburg University, 06.10.2020
• S. Vöneky, Ein globaler Verhaltenskodex zur Biosicherheit – Grundprinzipien und Kernelemente, Dialogforum zum Biowaffenübereinkommen, Auswärtiges Amt, tba
• E. Andersen, K. Schreiber, By Razor or by Chance: What a Court Decision Means for the Future of Plant Breeding, Interview about the CIBSS project, March 2020
• E. Andersen, K. Schreiber, The CJEU’s ruling on genome editing, Work in Progress CIBSS, 27.01.2020
• S. Vöneky, Biotechnology, Biosecurity and the Global Order, Freiburg Institute for Advanced Studies, 08.01.2020
• E. Andersen, K. Schreiber, Regulation of Genome Editing in the European Union, International Summer School – Universities of Freiburg, Nagoya, Straßburg, 18.09.2019
• S. Vöneky, International Standards Setting in Biomedicine, Symposium: International law and Human Health, Kiel University, 27.09.2018
• S. Vöneky, Evaluation and Impact of Existential Risk according to Public International Law, Cambridge Conference: Challenges of Existential Risk Research, 17.-18.04.2018, CSER, University of Cambridge/UK (Video)
• S. Vöneky, Legitimate Governance of Existential Risk, Symposium: Human Rights, Democracy, and Legitimacy in the 21st Century, Harvard Law School, Cambridge/US, 04.05.2016

• S. Voeneky, C. Born, L. Tribess, S. Weller, Vereinbarkeit des EU-Vorschlags für eine Verordnung über mit bestimmten neuen genomischen Techniken (NGT) gewonnenen Pflanzen mit dem Cartagena Protokoll über die biologische Sicherheit, EurUP 4, 2025, 450-466
• G. Demir, Digitale Sequenzinformationen unter dem (neuen) UN-Hochseeabkommen, in Feit/Stadler (eds.), BfN-Schriften 744 – Treffpunkt Biologische Vielfalt XXII. Interdisziplinärer Forschungsaustausch im Rahmen des Übereinkommens über die biologische Vielfalt, 58-59
• S. Voeneky, G. Demir, International Cooperation under the Human Right to Science in Light of New Developments in International Law, Human Rights-based Technology Transfer in the Field of Bioprospecting and AI?, in Besson/Achermann (eds.), Human Rights in Science (Edward Elgar, forthcoming 2026)
• C.Born, Neue Regeln für geneditierte Pflanzen in Europa? – Der Verordnungsvorschlag der EU-Kommission zu neuen genomischen Verfahren in der Pflanzenzüchtung, FIP 1/2024                                                                  
• K. Schreiber, Recht vs. Naturwissenschaften? Die Debatte zur Regulierung grüner Gentechnik in der EU, Paper for Bundeszentrale für politische Bildung, APuZ “Gentechnik” 2022, Vol. 72 (34-35), 27-32
• E. Andersen, K. Schreiber, European GMO regulation in need for change? Ways to the future regarding the risk regulation of genome editing techniques (to be published 2022)
• K. Schreiber, E. Andersen, S. Vöneky, Regulatory Framework for the Deliberate Release of Gene Drive Organisms on the National, European and International Level, in: GDRA – Gene Drive Risk Assessment, Final Project Report, 219 – 235 (forthcoming as BfN-Skript)
• L. Kemp, DC. Aldridge, O. Booy, H. Bower, D. Browne, M. Burgmann, S. Vöneky et al., 80 questions for UK biological security, PLoS One 2021
• E. Andersen, K. Schreiber, Neue Regeln für die Gentechnik in Europa? Eine Darstellung der faktischen Auswirkungen des EuGH-Urteils C-528/16 und der im Nachgang ergangenen Vorschläge für eine Reform des europäischen Gentechnikrechts, NuR 2020, 168-178
• E. Andersen, K. Schreiber, Neue Regeln für die Gentechnik in Europa? Eine Darstellung der faktischen Auswirkungen des EuGH-Urteils C-528/16 und der im Nachgang erganenen Vorschläge für eine Reform des europäischen Gentechnikrechts, FIP 3/2020
• E. Andersen, K. Schreiber, “Genome Editing” vor dem EuGH uns seine Folgen – Eine Darstellung der durch das EuGH-Urteil C-528/16 hervorgerufenen Reaktionen und ihre Bewertung, NuR 2020, 99-106
• E. Andersen, K. Schreiber, “Genome Editing” vor dem EuGH und seine Folgen – Eine Darstellung der durch das EuGH-Urteil C-528/16 hervorgerufenen Reaktionen, FIP 11/2019 
• S. Vöneky, Legal Framework, in Ethics Council of the Max Planck Society (ed.), Discussion paper focusing on the scientific relevance of genome editing and on the ethical, legal and societal issues potentially involved, 2019, Chapter 7, 17-22
• S. Vöneky, Bioprospection – Gerechte Verteilung genetischer Ressourcen, in Nida-Rümelin/von Daniels/Wloka (eds.), Zwischen internationaler Gerechtigkeit und institutioneller Verantwortung, 2019, 341-355
• S. Vöneky, Human Rights and Legitimate Governance of Existential and Global Catastrophic Risks, in Voeneky/Neuman (eds.), Human Rights, Democracy, and Legitimacy in a World of Disorder, CUP, 2018, 139-162
• S. Vöneky, Agricultural research, or a new bioweapon and its means of delivery? , Science 05 Oct 2018, Vol. 362, Issue 6410, pp. 35-37
• S. Vöneky, International Standard Setting in Biomedicine – Foundations and New Challenges, GYIL 61 (2018), 131-151
• S. Vöneky, Biotechnologie und der rechtliche Rahmen der künftigen Weltgesellschaft, in Messner/Mair/Meyer (eds.), Deutschland und die Welt 2030, 265-273
• S. Vöneky, F. Beck, Umweltschutz und Menschenrechte, in Proelß (ed.), Internationales Umweltrecht, 2017, 133-182
• S. Vöneky, Das Recht der Biomedizin auf dem Prüfstand des EGMR – Grundrechtseingriffe und die Lehre vom weiten Beurteilungsspielraum des nationalen Gesetzgebers, MedR 32, 2014, 704-711
• S. Vöneky, Recht, Moral und Ethik, in Puhl et al. (eds.), Leitgedanken des Rechts: Paul Kirchhof zum 70. Geburtstag, Heidelberg 2013, 333-350
• S. Vöneky, Ethisches Expertentum und moralischer Autoritarismus, in Vöneky/Hagedorn/Clados/von Achenbach (eds.), Legitimation ethischer Entscheidungen im Recht – Interdisziplinäre Untersuchungen, Heidelberg 2009, 85-97