13 - The Regulation of Human Germline Genome Modification in Spain

Summary

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.