CIBSS – Responsible Science and Technology

Our research project is based on three pillars during the second funding period:

For the first pillar, the project will build on the work and results of the first-round project and continue to analyse from a legal and ethical angle the ongoing intense debate about the future regulation of biotechnology in the EU. 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 aims at developing 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. Questions that arise in this context concern the proportionate regulation of biotechnology in a pluralistic world, the still unclear relation between the precautionary principle and science-based regulation, and human rights implications. Hence, the project will assess these principles in more detail as they could be the foundation of a future biotechnology regulation. One main challenge will be to analyse the distinctive differences and overlapping features between the precautionary principle and a science-based approach to biotechnology and risk regulation, and to assess the consequences that arise out of differences of these two concepts for a future regulation. The results of the first funding period show that the legal framework both on the European and international level is based on the precautionary principle. However, the US as a major actor is not bound by this principle in the area of biotechnology. This requires a basis that might bridge the gap between these concepts. In this regard, possible approaches that need to be assessed may include new perceptions on the ethics of risk, the examination of reservations from a rational point of view as well as processes of public consultation and participation. Besides, human rights might function as an instrument to overcome this regulatory gap, 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.

This is how the third pillar of the project, research on human rights, becomes relevant: human rights implications on biotechnology and research in this field might provide a common basis when developing a legitimate and proportionate regulation, evaluating benefits as well as risks of biotechnological innovations and uncertainties. Human rights obligations enshrined in the Covenants, such as the right to health or the freedom of science, can influence how to weigh benefits of biotechnology in a future regulation. Human rights may also call for an efficient regulation of biotechnological applications due to possible risks for human health and life or because of the need for consent, e.g. in the context of the deliberate release of GMOs in the environment or in the context of clinical trials. Furthermore, the role of human rights and international law for scientific research and the exchange of data (especially relating to genetic sequences) in the field of biotechnology shall be assessed. What can be seen today is that there is a tendency towards the development of a universal right to participate in scientific progress (cf. UN CESCR, General Comment No. 25 (2020)).

Research during the first funding period (January 2019 – June 2022) focused on the European GMO regulation, its applicability to genome edited plants and, its ethical and international law implications. The second project round (starting in July 2022) will build on the outcome of the first project round, especially concerning a future regulation of biotechnology and its foundations.

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 upcoming debate concerning a new regulation for genome edited plants in the EU was analysed.

• Born, Constantin: Klinische Arzneimittelprüfungen mit Minderjährigen (second funding period)
• Demir, Gizem: Marine Bioprospecting – in Light of the New High Seas Treaty (second funding period)
• Andersen, Elisabeth: The EU regulation of genome edited plants in light of WTO law and CETA (University of Freiburg) (first funding period, dissertation under review)
• Schreiber, Katharina: Recht und Ethik der Risikoregulierung in der Grünen Gentechnik. Das Vorsorgeprinzip in der Rechtssache C-528/16 Confédération paysanne (University of Freiburg) (first funding period, published 2023 – Springer Verlag, 420 S.)

Gutachten für den Deutschen 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

• S. Vöneky, Wie adaptiv ist die Regulierung der grünen Gentechnik?, Vortrag im Rahmen der Reihe „Grüne Gentechnik – Chancen für die Nachhaltigkeit?“, Freiburg University, 04.12.2024, 20 c.t.
• C. Born, Moderne Gentechnik – Den Code des Lebens verändern, Vortrag in der „Hörsaal“-Reihe von Deutschlandfunk Nova, 13.9.2024 
• G. Demir, Digitale Sequenzinformationen unter dem (neuen) UN-Hochseeabkommen, Aktuelle Biodiversitätsforschung (Bundesamt für Naturschutz), 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

• G. Demir, Digitale Sequenzinformationen unter dem (neuen) UN-Hochseeabkommen, BfN Schriftenreihe, Treffpunkt Biologische Vielfalt, Interdisziplinärer Austausch im Rahmen des Übereinkommens über die biologische Vielfalt (forthcom.)
• 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?, International Cooperation under the Human Right to Science, University of Fribourg, Switzerland, 5-6 September 2024 (forthcoming publication, ed. Samantha Besson 2024/25)
• 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