Regulating Germline Editing in Assisted Reproductive Technology: An EU Cross-disciplinary Perspective

Posted: 10 Dec 2018 Last revised: 15 Jan 2020

See all articles by Ana Nordberg

Ana Nordberg

Faculty of Law, Lund University, Sweden

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

Oliver Feeney

Centre of Bioethical Research and Analysis (COBRA), National University of Ireland (Galway), Rep. of Ireland

Iñigo de Miguel Beriain

Independent

Lucia Galvagni

Independent

Kirmo Wartiovaara

Independent

Multiple version iconThere are 2 versions of this paper

Date Written: July 15, 2018

Abstract

Potential applications of genome editing in assisted reproductive technology (ART) raise a vast array of strong opinions, emotional reactions and divergent perceptions. Acknowledging the need for caution and respecting such reactions, we observe that at least some are based on either a misunderstanding of the science or misconceptions about the content and flexibility of the existing legal frameworks. Combining medical, legal and ethical expertise, we present and discuss regulatory responses at the national, European and international levels. The discussion focus on the EU as a starting point and is meant as a contribute to the general international regulatory debate. Overall, this paper concludes that gene editing technologies should not be regulated autonomously. Rather, potential uses should be regulated under general, existing frameworks and where applicable by reference to sufficiently equivalent technologies and techniques already subject to specific regulation. To be clear, we do not argue for the hasty introduction of gene editing as a reproductive treatment option in the immediate future. We call for caution with regard to overreaching moratoria and prohibitions which will also affect basic research. We recommend flexible regulations that allow for further responsible research into the potential development of the technology. We call for an open and inclusive debate and argue that scientific communication should claim a more prominent role to counter the danger of widespread misinformation. A high level of transparency and accuracy should guide scientific communication while simultaneously global-scale responsibility and governance should be fostered by promoting cross-disciplinary thinking and multi-level stakeholder involvement in legal and regulatory processes.

Keywords: Assisted Reprudution Technology, Gene Editing & Law, Human Enhancement, Bioethics & Law, Bioethics & Genetics, Techn Regulation

Suggested Citation

Nordberg, Ana and Minssen, Timo and Feeney, Oliver and de Miguel Beriain, Iñigo and Galvagni, Lucia and Wartiovaara, Kirmo, Regulating Germline Editing in Assisted Reproductive Technology: An EU Cross-disciplinary Perspective (July 15, 2018). Available at SSRN: https://ssrn.com/abstract=3285731

Ana Nordberg (Contact Author)

Faculty of Law, Lund University, Sweden ( email )

Lilla Gråbrödersgatan 4
Lund, 222 22
Sweden
+46462221054 (Phone)

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law ( email )

Karen Blixens Plads 16
Copenhagen, 2300
Denmark
+46 708 607517 (Phone)

HOME PAGE: http://jura.ku.dk/cebil/staff/profile/?pure=en/persons/381631

Oliver Feeney

Centre of Bioethical Research and Analysis (COBRA), National University of Ireland (Galway), Rep. of Ireland ( email )

University Road
Galway, Co. Kildare
Ireland

Iñigo De Miguel Beriain

Independent

No Address Available
United States

Lucia Galvagni

Independent

No Address Available
United States

Kirmo Wartiovaara

Independent

No Address Available
United States

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