Settori ERC:
Durata:
In the post-genomic era, humanity has become aware of the possibility of transforming—not only the known object, but also the knowing subject. The new genetic engineering techniques make it possible to imprint the human body with an “artificial” evolution: the DNA sequence can be modified to cure or prevent diseases (more or less likely), or to construct the physical characteristics of the individual.
On January 8, 2025, the medical journal Nature published an editorial titled “We need to talk about human genome editing,” highlighting the need to start a conversation on what might happen if more sophisticated gene-editing technologies become available. The law is called upon to regulate these unforeseen developments in medical technology, placing limits to curb the technological process or redirect it toward predefined goals.
New legal issues are emerging on the horizon: on the one hand, one can imagine an individual’s right not to undergo—through genetic manipulation—the heteronomous determination of their future life; on the other hand, it is not ruled out that—once gene editing techniques have been perfected—an individual affected by a genetic disease might invoke a right “not to be born unless edited.” The legal debate is made more challenging by the subtle distinction between therapeutic and enhancement purposes.
Purpose:
Genetic engineering, by allowing intervention on germ cells (as well as somatic cells), calls into question the entire framework of rules and principles that protect genetic identity, both of the individual concerned and their descendants. This risks creating new forms of discrimination, giving rise to prohibited eugenic practices, and increasing the risks of commercialization of biological samples (especially if edited), thereby violating the principle of human dignity and compromising the legal certainty of relationships, including family relationships.
Therefore, with the awareness that genetic editing could nonetheless bring significant benefits to personalized medicine and disease prevention, the research primarily aims to identify its admissibility limits, taking into consideration the need to protect the fundamental rights of the individual. Moreover, the regulations concerning genetic manipulation (see, in particular, Article 13 of the Oviedo Convention and Article 13 of Law 40/2004), while prohibiting such practices, seem to allow them for diagnostic, therapeutic, or preventive purposes. Consequently, in order to identify the scope for admissibility of genetic editing, the research seeks to delineate the boundary between permissible therapeutic interventions and prohibited human enhancement interventions, taking into account the current definitions of disease and health, the distinction between Mendelian diseases, multifactorial diseases, and polygenic mutations.
Attività / Fasi del progetto:
It will be necessary to address the issues of protecting the personal identity of those involved (and of any third parties), with particular attention to the aspects of protection and circulation of "edited" genetic data, in order to evaluate the adequacy of current regulations, and, if necessary, to identify the most suitable rules and principles to ensure a satisfactory balance between the protection of the individual and the freedom of research. To this end, particular attention will be given to the role of explicit consent as a tool that allows individuals to maintain adequate control over information concerning them.
Furthermore, given the close connection between biological samples and genetic data, the circulation of biomaterial from people born as a result of genetic editing, or who have undergone such procedures, will also be addressed. To this end, consideration will not only be given to the most recent regulatory sources regarding the circulation of substances of human origin (see, for example, EU Regulation 2024/1938 on quality and safety standards for substances of human origin intended for application in humans), but also to the most significant decisions made on the subject, which show how the need to protect individuals must be balanced with the need to guarantee progress, the sharing of scientific discoveries, and the protection of future generations.
Finally, to the extent that genetic editing is deemed permissible, both the aspects of liability (including medical liability) related to genetic manipulation interventions (particularly in relation to cases of unintentional changes, the so-called off-target effects), as well as the sensitive issues related to the impact of such practices on parental responsibility, and on family and inheritance relationships, will be addressed.
Pubblicazioni:
L. Dani, The Processing of Genetic Data in Insurance Contracts, in Annali della SISDiC, no. 13/2025, pp. 31-63. ISSN 2612-2790 (Class A journal).
Coordinatore:
Team:
Prof. Paolo Morozzo Della Rocca, Dr. Leonardo Dani