This work, which began in November 2017, started with the ambition of reconstructing the response that the legal system provides to the new genetic engineering techniques that, in view of their applicability on human beings, have produced, in recent years, the rise of new stakeholders and, even before that, of new interests worthy of protection.If until a few years ago it seemed unthinkable to modify the human genome and, even less, to do it in a precise, efficient and economical way, today thanks to the CRISPR / Cas9 genetic modification system it is possible, by intervening on the germ line of human embryos, to prevent contraction of hateful genetic diseases and, even in the medium term, eradicate them from our society. The enormous therapeutic potential of this technique has even attracted the attention of the Royal Swedish Academy of Sciences which, just as these lines are being written, attributed to its inventors, Jennifer Doudna and Emmanuelle Charpentier, the Nobel Prize in Chemistry 2020, defining CRISPR / Cas9 as “a revolutionary gene editing method that contributes to the development of new cancer therapies and can fulfill the dream of curing hereditary diseases” (The Royal Swedish Academy of Sciences 2020a). Alongside these perspectives, which have become increasingly evident since 2017, there are risks and dangers arising from the use of genetic engineering techniques that the law must take into due consideration when regulating them. In the first months of work, dedicated precisely to the reconstruction of the applicable legal sources, we were immediately struck by the fact that despite the techniques in question are, still today, an absolute novelty in continuous change, the legal rules, both supranational and national, are relatively old. over time: law 40 which, in Italy, aims to regulate medically assisted procreation and to lett. b) of the co. 3 of its art. 13 deals with genetic manipulation dates back to 2004, while the most relevant provision on this point at an international level, art. 13 of the Oviedo Convention, is even dated April 1997. In short, in this field the law, rather than appearing in physiological delay, has drawn up regulations that are suspiciously early. This observation, combined with the results of the reconstruction of the doctrinal debate, where even highly authoritative authors continually combine ethical and legal arguments, often without even differentiating them, led us to ascertain how before addressing the specific regulation of genome editing it was necessary to reflect on how the law interfaces before the bios as a normative object and, above all, in what relationship it places itself with bioethics in carrying out this function.

This work, which began in November 2017, started with the ambition of reconstructing the response that the legal system provides to the new genetic engineering techniques that, in view of their applicability on human beings, have produced, in recent years, the rise of new stakeholders and, even before that, of new interests worthy of protection.If until a few years ago it seemed unthinkable to modify the human genome and, even less, to do it in a precise, efficient and economical way, today thanks to the CRISPR / Cas9 genetic modification system it is possible, by intervening on the germ line of human embryos, to prevent contraction of hateful genetic diseases and, even in the medium term, eradicate them from our society. The enormous therapeutic potential of this technique has even attracted the attention of the Royal Swedish Academy of Sciences which, just as these lines are being written, attributed to its inventors, Jennifer Doudna and Emmanuelle Charpentier, the Nobel Prize in Chemistry 2020, defining CRISPR / Cas9 as “a revolutionary gene editing method that contributes to the development of new cancer therapies and can fulfill the dream of curing hereditary diseases” (The Royal Swedish Academy of Sciences 2020a). Alongside these perspectives, which have become increasingly evident since 2017, there are risks and dangers arising from the use of genetic engineering techniques that the law must take into due consideration when regulating them. In the first months of work, dedicated precisely to the reconstruction of the applicable legal sources, we were immediately struck by the fact that despite the techniques in question are, still today, an absolute novelty in continuous change, the legal rules, both supranational and national, are relatively old. over time: law 40 which, in Italy, aims to regulate medically assisted procreation and to lett. b) of the co. 3 of its art. 13 deals with genetic manipulation dates back to 2004, while the most relevant provision on this point at an international level, art. 13 of the Oviedo Convention, is even dated April 1997. In short, in this field the law, rather than appearing in physiological delay, has drawn up regulations that are suspiciously early. This observation, combined with the results of the reconstruction of the doctrinal debate, where even highly authoritative authors continually combine ethical and legal arguments, often without even differentiating them, led us to ascertain how before addressing the specific regulation of genome editing it was necessary to reflect on how the law interfaces before the bios as a normative object and, above all, in what relationship it places itself with bioethics in carrying out this function.