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CIBSS - Responsible Science and Technology

The Legal and Ethical Framework of Control-of-Function Research Technology

 

 

About

'Responsible Science and Technology - The Legal and Ethical Framework of Control-of-Function Research Technology' is a project under the auspices of the Cluster of Excellence CIBSS - Centre for Integrative Biological Signalling Studies at the University of Freiburg dealing with legal and ethical implications of control-of-function approaches.

Our project supports the CIBSS aim to develop innovations to meet global challenges in biomedicine, plant sciences and biotechnology applications. On the one hand, this aim requires a research environment that enables scientific freedom and the exchange of scientific results. On the other hand, global challenges in biomedicine, plant sciences and biotechnology applications are only met in a regulatory environment that supports new scientific innovations in a responsible way. To this end, the research group analyses whether and to what extent existing conventions are applicable to new technological developments in those fields. Accordingly, our project aims to develop a regulatory proposal that enables innovative research in the field of signalling studies and then contributes to face global challenges. Here again, human rights-based obligations are of particular relevance, because they set internationally legally binding standards.

 

Aims

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 enable 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 concept of rationality of emotions as well as processes of public consultation and participation. Besides, human rights might function as an instrument to overcome this regulatory gap, esp. 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)).

 

Members of the Research Group (Second Funding Period)

Prof. Dr. Silja Vöneky 

Director Institute of Public International Law and Ethics of Law,

University of Freiburg

Phone: +49.761.203-2206

                     

 

Constantin Born  Phone: +49.761.203-2243
Gizem Demir  Phone: +49.761.203-67648

 

 

First Funding Period

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 et al. ./. Premier ministre et al., 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.

 

Research Assistants (First Funding Period)

Elisabeth Andersen  Phone: +49.761.203-2243
Katharina Schreiber  Phone: +49.761.203-2243  

 

PhD Projects

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.)

 

Third Party Funded Projects

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

 

Presentations/Interviews

  • 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

 

Selected Publications

  • S. Vöneky, International Standard Setting in Biomedicine - Foundations and New Challenges, GYIL 61 (2018), 131-151
  • 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

 

Contact

Institute of Public Law
Department 2 (Public International Law and Comparative Law) - Prof. Dr. Silja Vöneky
Werthmannstr. 4 
79098 Freiburg im Breisgau
Germany

Phone: +49.761.203-2206
Fax: +49.761.203-67683