The Regulation of Human Germline Genome Modification in Italy

Abstract

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 but, at the same time, fails to define what an embryo is and, surprisingly, might have left the door open to clinical application of therapies that modify the human germline genome. This chapter first discusses the general regulatory environment for scientific work involving human germline genome modification. After having introduced the hierarchy of norms in the Italian legal system, it considers in detail relevant provisions of the Italian Constitution, European Union (EU) law, international treaties ratified by Italy, and Law 40/2004. The second part of the chapter aims at assessing whether and to what extent research using human germline genomemodification technologies, as well as clinical applications of such techniques, is permitted under the Italian legal system. Finally, it offers some remarks on future perspectives.