Governing Gene Editing in the European Union: Legal and Ethical Considerations

Abstract

The chapter analyses the re-emergence of gene editing as an object of policy attention at the European Union (EU) level. Editing the genome of plants and/or animals has been a rather controversial component of all EU policies on agricultural biotechnology since the late 1980s. The chapter examines in detail the various initiatives that have been assumed for the regulation of gene editing at the EU level. Since the first political and legislative attempts, the field has been revolutionized with the development of the CRISPR-Cas9 system, which is comparatively much easier to design, produce, and use. Beyond the pure, safety-driven scientific questions, gene editing, in its contemporary form, raises a series of ethical and regulatory questions that are discussed in the context of the legal options and competences of the EU legislators. Special attention is paid to questions about the legal status of gene editing in Europe and the adequacy of the current GMO framework to deal with all the challenges associated with the latest scientific developments in the field of gene editing with a special focus on gene drive. Given the ongoing discussions regarding the ethical tenets of gene editing, the chapter investigates the question on whether there is a need to shape an EU-wide “intervention” that will address the complex and dynamic socio-ethical challenges of gene editing and puts forward a series of proposals for the framing of an inclusive framework that will be based on the need to re-enforce public trust in the EU governance of emerging technologies.

Citation

Kritikos, M. (2018), "Governing Gene Editing in the European Union: Legal and Ethical Considerations", Ethics and Integrity in Health and Life Sciences Research (Advances in Research Ethics and Integrity, Vol. 4), Emerald Publishing Limited, Leeds, pp. 99-114. https://doi.org/10.1108/S2398-601820180000004007