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What Would It Take to Enable Germline Editing in Europe for Medical Purposes?
Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.ORCID iD: 0000-0002-5621-8485
2022 (English)In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 29, no 3-5, p. 521-542Article in journal (Refereed) Published
Abstract [en]

Commonly, the regulation on germline editing in Europe is described through the two prohibitions: the prohibition set out in Article 13 of the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine and the prohibition that is set out in the EU Clinical Trials Regulation. These prohibitions reflect the European regional position regarding the ethical and legal questions raised by the technology, and an unwillingness to enable such interventions in Europe. Simultaneously, these prohibitions have been shaped prior to the recent breakthroughs in the field, such as the discovery of the CRISPR-Cas technology, which has initiated a new era in the field. This contribution examines what it would take to enable human germline gene editing in Europe for medical purposes. It scrutinises in detail the content and context of the existing bans, as well as mechanisms to lift them. It argues that the bans that are prescribed by each of the European regional legal orders are embedded in strong structures, composed of values and principles. For the human germline gene editing to be enabled in Europe for health-related purposes, the approach to these values and principles needs to change. Only then can the machinery to lift the bans lead to a change.

Place, publisher, year, edition, pages
Brill Nijhoff, 2022. Vol. 29, no 3-5, p. 521-542
Keywords [en]
Biomedicine Convention Article 13, Clinical Trials Regulation Article 90, gene therapy, germline gene editing
National Category
Law Health Care Service and Management, Health Policy and Services and Health Economy
Research subject
Medical Law
Identifiers
URN: urn:nbn:se:uu:diva-485720DOI: 10.1163/15718093-bja10074ISI: 000881764700009Scopus ID: 2-s2.0-85129534014OAI: oai:DiVA.org:uu-485720DiVA, id: diva2:1699224
Available from: 2022-09-27 Created: 2022-09-27 Last updated: 2023-03-09Bibliographically approved

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