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effectively functioned prior to the advances in gene editing technology, today it may be regarded as ambiguous and outdated.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