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In the conclusions, the book editors assess the existing national and international regulatory frameworks in the light of the five foundational principles that they identified by reading international bioethics law in conjunction with international human rights standards: (i) freedom of research; (ii) benefit sharing; (iii) solidarity; (iv) respect for dignity; and (v) the obligation to respect and to protect the rights and individual freedoms of others. Their analysis reveals four issues common to most national regulatory frameworks as well as the international framework: (i) The prohibition to create embryos for research embryos cannot be reconciled with the right to science and the rights of science; (ii) limitations to scientific freedom based on vague laws are not truly limitations “determined by law”; (iii) limitations to scientific freedom based on obsolete laws are not limitations accepted in a “democratic society”; (iv) ne plus ultra prohibitions breach the right of everyone to benefit from scientific and technological progress and the principle of benefit sharing. The editors conclude by sketching an international governance framework that promotes science and technological development while being mindful and respectful of international human rights standards, as well as the different sensitivities with which citizens from different parts of the world approach the question of human germline genome modification.
In this Introduction (Chapter 1), we discuss the science of human genome modification in general, how it relates to human reproduction, and the specific advances that CRISPR/Cas 9 represents and the family of tools it has generated to date. We then explain the methodology we followed preparing this book, including how countries were selected and what we chose to focus on and why.
The advent of the CRISPR/Cas9 class of genome editing tools is transforming not just science and medicine, but also law. When the genome of germline cells is modified, the modifications could be inherited, with far-reaching effects in time and scale. Legal systems are struggling with keeping up with the CRISPR revolution and both lawyers and scientists are often confused about existing regulations. This book contains an analysis of the national regulatory framework in eighteen selected countries. Written by national legal experts, it includes all major players in bioengineering, plus an analysis of the emerging international standards and a discussion of how international human rights standards should inform national and international regulatory frameworks. The authors propose a set of principles for the regulation of germline engineering, based on international human rights law, that can be the foundation for regulating heritable gene editing both at the level of countries as well as globally.
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