This foundational technology provides tools that enable researchers with a basic knowledge of biochemistry and molecular biology to modify with improved precision the genetic structure of any living organism. Gene-editing technology, such as CRISPR/Cas9, 3 holds the potential to guide seminal discoveries within basic science and open a Pandora's box of practical applications. The analysis will include brief references to corresponding USA rules in order to place these European debates in the broader international context.
The present piece is an European perspective written for a global audience, intended as a research contribute to the global debate on how to regulate the potential uses and applications of gene-editing technology. While the questions raised by gene editing are global, laws and rules are to a great extent bound by national borders. Our legal analysis incorporates contextual elements, based on a legal reflection built upon interdisciplinary contributes such as the scientific state of the art, philosophical analysis concerning the precautionary principle and the dual-use problem, the importance of communication, social perception, and public debate. We argue that before society can harness this technology's potential it is imperative to consider from a broader societal and value-based perspective not only the enormous benefits that gene editing may bring, but also its problematic aspects.
Taking into account the international context, we identify and debate some of the perceived legal and regulatory challenges that scientists, legislators, and society as a whole face in Europe. This paper is the result of an interdisciplinary research project conducted by a European group of lawyers, biologists, philosophers, social scientists, and physicists. Given the complexity and the great variety of applications of the technology, this calls for an interdisciplinary effort and the incorporation of interdisciplinarity in legal thinking. This highlighted once more that it is more pressing than ever to debate and make national and international decisions on how to interpret, adapt, or produce adequate rules and regulations. The announcement sparked controversy, igniting strong reactions in the scientific community, and fueled public debate concerning the regulation of gene-editing technology. 2 Reportedly, the embryos used were unviable and not intended to be implanted. 1 Chinese laws and regulations did not explicitly control or monitor research concerning modification of the germline of humans. In April 2015, Chinese scientists announced the use of gene-editing technology in human embryos. Focusing mainly in the main regulatory and patent law issues, we will argue that (a) general moratoriums and blank prohibitions do a disservice to science and innovation (b) it is crucial to carefully consider a complex body of international and European fundamental rights norms applicable to gene editing (c) these require further developments grounded in consistent and coherent implementation and interpretation (d) legal development should follow a critical contextual approach capable of integrating interdisciplinary contributions and broad multilevel societal dialog. Our legal analysis incorporates interdisciplinary contributes concerning the scientific state of the art, philosophical thinking regarding the precautionary principle and dual-use issues as well as the importance of communication, social perception, and public debate. This paper presents a European perspective, written for a global audience, and intends to contribute to the global debate. While the questions raised by gene editing are global, laws and regulations are to a great extent bound by national borders. This paper stems from an interdisciplinary research project seeking to identify and discuss some of the most pressing legal implications of gene-editing technology and how to address these. Any legislative initiative needs to consider both the benefits and the problematic aspects of gene editing, from a broader societal and value-based perspective. This requires an interdisciplinary effort in legal thinking. Yet, in order to enhance its potential for societal benefit, it is necessary to adapt rules and produce adequate regulations.
This foundational technology enables modification of the genetic structure of any living organisms with unprecedented precision. Gene-editing technology, such as CRISPR/Cas9, holds great promise for the advancement of science and many useful applications technology.