This chapter discusses the regulation of germline editing in Europe, the only region in the world to date to have set up a regulatory framework for biomedical research. First, we consider the principal contributions of the Council of Europe to this framework. After a brief introduction of the history, goals and structure of this organization, we analyse key provisions of the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention) as well as its additional protocols. Relevant case law of the European Court of Human Rights related to the protection of human embryos is also taken into account. Then we turn to the European Union (EU) to examine its efforts to articulate a regulatory for biomedical research. Again, after a brief introduction to the EU, we discuss the basic elements of its framework. This includes the relevant rights included in the EU Charter of Fundamental Rights, the EU directive on the legal protection of biotechnological inventions (98/44/EC) and the EU regulation on clinical trials on medicinal products for human use (EU 536/2014), as well as significant case law of the European Court of Justice. Throughout our analysis, we highlight contradictions, gaps and unresolved issues of the current European regulatory framework, which slow down or even block scientific advancement on human germline modification in Europe. We conclude the chapter not only by pointing to the need for a public debate to address the challenges faced, but also by acknowledging the difficulties of making progress in the light of the complexity of the EU framework and the current political climate.

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 chapter, we review the key elements of the larger international and transnational framework within which the national legal regimes regulating human germline genome modification exist. Part I is a quick primer to international law and international human rights for the benefit of those who are not familiar with them. Part II presents the relevant norms of international bioethics law, including three main declarations adopted by UNESCO touching on human genome modification. It discusses also the relevant governance activities of the World Health Organization, Organisation for Economic Co-operation and Development and civil society, nationally and transnationally. Part III discusses relevant international human standards, and in particular the so-called ‘right to science’ and the ‘rights of science’. Finally, Part IV discusses how these rights can contribute to the emerging international regulatory framework. This chapter argues that, by itself, international bioethics law and its instruments provide a narrow and inadequate description of the range of human rights that must be taken into account in the conversation on the regulation of germline engineering. These instruments must be integrated with the broader international human rights law corpus. When they are integrated, five key principles emerge as foundations of the emerging regulatory framework: freedom of research; benefit sharing; solidarity; respect for dignity; and the obligation to respect and to protect the rights and individual freedoms of others.

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.