Modifying the human germline: a study of the applicable Spanish regulations

Abstract

The question of the legal regulation of genetic editing in Spain is, at least, thorny, because it covers, in general, norms elaborated in a historical context very different from the current one, a context in which gene therapies were still considered very dangerous. Hence, the regulation of the time was very strict, prioritizing safety over the possible (although unlikely) benefit that its use could bring. To this must be added that the legislative technique used was not refined, because it contained arcane clauses, difficult to understand and ductile interpretation, which did not help too much to obtain the precious legal certainty. Unfortunately, this framework has not undergone substantial changes until now despite the fact that the state of science certainly has. As a consequence, we can only speak of a certain mismatch between the needs of biological research and the legal responses that, hopefully, will be solved at any time. Entering now to expose the keys of the system, it is convenient to underline that there are three great normative documents that deal with regulating this matter: the Oviedo Convention, Law 14/2007, on biomedical research and the same Spanish Penal Code. In the following pages we will dedicate ourselves to expose what is exactly (and what is not) deduced from its articles.