Sweden can be considered a relatively liberal European country when it comes to research, for example, it allows creating embryos for research purposes; yet, the question of human germline genome modification has been approached with great caution. With the adoption of the Genetic Integrity Act in 2006, the Swedish legislature intended to enable some research relating to gene editing technology while simultaneously placing bans on its use in clinical trials and clinical care, and providing criminal sanctions if these bans are violated. In this way, Swedish law is also aligned with its external commitments, and in particular, the EU Clinical Trials laws. While arguably the Genetic Integrity Act could have effectively functioned prior to the advances in gene editing technology, today it may be regarded as ambiguous and outdated. Hence, risks that ethically contested practices could emerge cannot be excluded. This chapter examines the national laws and policies relating to human germline genome modification in research and in clinical care in Sweden, with due regard to Sweden’s external commitments. Importantly, in light of the ongoing regulatory discussions at the national, European and international fora, it is not obvious that, should European laws become more permissive, and enable human germline genome modification, so would Swedish national law.

For historical, social, political and religious reasons, Italy has traditionally approached life sciences, especially those involving humans, with great caution. The main law touching on human germline genome modification, called Law 40/2004 (‘Rules on Medically Assisted Reproduction’) bans most ‘experimentation’ on human embryos. In addition, EU Regulation 536/2014 contains a ban on clinical research using germline modification technologies. Nevertheless, Article 13 of Law 40/2004 leaves the door open to clinical applications of germline modification technologies. However, only the improvement of basic research on gametes would permit in the future to decide if, and possibly identify which, clinical applications are scientifically feasible and ethically acceptable. Recent developments and new possibilities in the field of human germline genome modification call for regulations that, while setting limits to contain possible abuses, do not wholly frustrate scientific and technological progress. Moreover, human germline genome modification technologies, which have enormous therapeutic potential, can further certain values enjoying a constitutional status under the Italian legal system, such as the promotion of scientific progress and the protection of health.

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.

Canada’s approach to human germline modification is generally conservative, at times unclear, and largely prohibitive from both a research and clinical perspective. To date, no research using human germline modification has been undertaken in Canada. This chapter provides an overview of the Canadian legal and policy landscape surrounding human germline modification. It will begin by laying the groundwork for the subsequent assessment of specific legal provisions and policies governing the modification of the human germline from basic research to clinical applications. Finally, it will reflect on the challenges and future possibilities for human germline modification in Canada.

This chapter provides an overview of the ethical, legal, and policy framework of the Republic of Korea applicable to research on human germline genome modification and of the political and social fundaments behind it. It introduces the legal system and describes specific laws and policies related to the research on human embryos including the Constitution and the Bioethics and Safety Act. The legal framework applicable to the modification of the human genome is subsequently presented going from basic research to clinical application. The final part of our text critically reviews the implications of technological advancements in this field for legal reform, including the possibility of integrating solutions from international human rights instruments to develop a more progressive, yet responsible, national regulatory framework to human germline genome modification.