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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have effectively functioned prior to the advances in gene editing technology, today it may be regarded as ambiguous and outdated.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.
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.
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.
Australia was at the cutting edge in the development of Artificial Reproductive Technology in the 1960s and 1970s. Regulatory responses were piecemeal: only a small number of the six states and two territories enacted legislation. The regulatory response to reproductive cloning and embryonic stem cell research has been more uniform, with nationally consistent legislation in the form of the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002, together with the Gene Technology Act 2000. This regulatory regime creates a prohibitory environment for germline genome therapy in Australia and provides little scope for genome editing research involving human embryos, even under licence. This chapter discusses the Australian regulatory regime, with particular focus on this triad of legislative instruments. Although Australia has made a commitment to science and health, and recognition of the right to found a family, the special status of the embryo is a paramount consideration. This chapter concludes that, as in many other countries, Australia is at a crossroads, and Australians must decide, collectively, how far genome editing research involving human embryos should be allowed to progress.
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.
This chapter offers a paramount analysis of Spain’s regulatory framework for human gene editing. This is a particularly complex task, due to several reasons. First, Spain not only ratified the Oviedo Convention, which rules gene editing, but has also developed a national legal framework that sometimes contradicts it. Second, many competencies related to monitoring and control have been developed at the regional level to “autonomous communities” (Comunidades Autónomas). In general, the Spanish response to the issues posed by human gene editing can be summarized like this: somatic gene editing is perfectly acceptable, once the corresponding administrative steps are taken. Germline gene editing, instead, is illegal provided that it affects someone's descendants. The legal stature of basic science involving germline gene editing remains unclear. The final decision should be adopted in a case-by-case analysis by corresponding ethics committees.
In France, civil law provisions on research involving human subjects, on donation and use of human body parts, and on medically assisted reproduction – originally developed between 1988 and 1994 and generally referred to as loi de bioéthique (law on bioethics) – specify whether and under which statutory conditions activities potentially leading to human germline genome modification can be undertaken. International law, including European law, poses further conditions. This chapter explores legislative and regulatory constraints on this type of research in France, analyzing how they developed over time to reach their present state. We will show that, in France, it is prohibited to create a human embryo solely for research purposes; that, however, research activities on supernumerary embryos and human embryonic stem cells are possible upon authorization by the national agency on biomedicine; but that, nevertheless, alterations to the genome of an embryo under circumstances that allow the modifications to pass on to future generations (i.e. through a successful pregnancy) are strictly prohibited. A peculiar feature of French legislation in this domain is that the law on bioethics is regularly updated in light of new technological or scientific developments, and as a result of a national public consultation held at least every five years. In 2018 one such rounds of public consultation took place, and a report summarizing its outcome is now being considered as the basis for possible legislative reform – including in the domain of genetic engineering. While it is not possible to anticipate future legislative developments, the report signals some degree of openness in the French civil society regarding the use of genetic engineering and genome editing, at least in the context of research.
This chapter examines the regulatory framework governing the use of human embryos and gametes in treatment and research in the United Kingdom. This framework, overseen by the Human Fertilisation and Embryology Authority (HFEA), permits the use of germline genome modification in human embryos for specific research purposes, but it does not currently allow such modified embryos to be used in treatment. The chapter goes on to consider how germline genome modification may become a licensable treatment in the future, building on the recent experience of regulating research into mitochondrial donation and its clinical application in the United Kingdom. The legal and ethical challenges raised against the use of mitochondrial donation (and likely to be raised against the clinical use of germline genome modification) are also considered, including concerns arising out of EU legislation.
The use of genetic technologies for reproductive, farming, agricultural and scientific purposes has long been a matter of public concern in Switzerland. As a result of a series of legislative initiatives at the federal level, as well as of popular referenda, the country developed one of the most restrictive regulatory environments in Europe for research, potentially leading to human germline genome modification. In particular, any genetic manipulation of reproductive cells or embryos is strictly forbidden, regardless its intended purpose. This chapter will illustrate the way constitutional- and federal-level legislation, as well as international law and regulatory provisions rigidly constrain research activities that could potentially lead to genetic alterations in humans and their progeny. In such a restrictive context, it is highly unlikely that recent technical advances in genetic engineering and genome editing will be employed to produce germline genome modifications for either medical or purely scientific purposes. Furthermore, while the Swiss National Advisory Commission for Biomedical Ethics has recently expressed partial support for basic research possibly involving the genetic modification of human embryos, there are currently no indications that legislative initiatives will be undertaken to ease current regulations on such controversial matters.
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.
Belgium regulates research on human embryos, including germline modification, mainly through the 2003 Law regarding Research on Embryos In Vitro and the 2007 Law regarding Medically Assisted Reproduction and the Disposition of Embryos and Gametes. It allows the creation of embryos for research when the research goal cannot be reached by research on supernumerary embryos. The lawmaker only recognizes a gradual difference between embryos created for reproduction and later used for research and embryos specifically created for research purposes. The general rule in research is that no research can be performed for eugenic goals, i.e., selection or improvement of non-pathological characteristics of the human species. Everything that is not prohibited by the law is allowed. The conclusion, supported by the parliamentary debate, is that germline genome editing is permitted for corrective purposes (meaning elimination or correction of genetic diseases), if approval of the local ethics committee and the Federal Commission on scientific research on embryos in vitro is obtained.
China’s advances in the field together with the size of its scientific community and resources, position it at the forefront of biotechnological and gene editing research. Most recently, the still unconfirmed report of the first life birth of humans following IVF and gene editing techniques, has place China at the center of the global scientific, socio-ethical, and legal debates. This makes understanding the Chinese regulatory framework and the strength of its governance to address the vast scientific, social, ethical, and political global implications of germline genome modification paramount. This chapter explores how the legal system in the People’s Republic of China (PRC) regulates human gene editing with particular focus on germline applications. It further outlines existing governance frameworks and addresses the possibility of policy convergence by contrasting Chinese approaches to those adopted worldwide.