Legal regulation dedicated to advance directives (ADs) do not yet exist in Turkey. However, the Patient’s Rights Regulation (1998), Convention on Human Rights and Biomedicine (2003) and professional guidance issued by several professional medical societies provide broad ethical and legal underpinning for advance care planning and emphasise the importance of taking into consideration a patient’s previously expressed wishes. Although these regulatory approaches have force, they have not been entirely harmonised in the jurisdiction. Thus, there is a need to legislate living wills and ADs based on human rights and dignity, which will help develop a more patient-centred healthcare, diminish paternalism and enhance patient–physician–relative interactions on the basis of trust, balancing patient autonomy in a pluralistic vein and honouring dying in dignity. This chapter considers ADs in Turkey, beginning with a consideration of the possible legal bases for such directives. It then explores the relevant professional guidance from medical associations, as well as empirical data relating to the level of awareness of ADs amongst patients and healthcare professionals. The sociocultural factors that pose potential obstacles to the introduction and implementation of ADs in Turkey are also discussed, and the chapter concludes with some thoughts about the way forward.

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have effectively functioned prior to the advances in gene editing technology, today it may be regarded as ambiguous and outdated.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.

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.

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.