CHAPTER 6: LEGAL ISSUES AND FOR THE HEALTH SYSTEM OF THE DEVELOPMENT OF A NEW CLASS OF INNOVATIVETHERAPY IN ONCOIMMUNOLOGY: THE “CAR-T CELLS”

Abstract

Car-T Cells are autologous or allogeneic lymphocytes cells, genetically engineered toexpress a transmembrane receptor called “chimeric” because it consists of the assembly of different parts of molecules. These new techniques using biotechnologies (cellular engineering and genetic modifications) are developing in a complex legal context integrat in the rules of the European Union (EU) and national rules, aiming to guarantee a high level of security for products and techniques but also for patients. This framework can be either considered as a guaranty for the use of new molecules in a highly secure environment oras an impediment, on the one hand regarding those who want to develop them because of a great complexity in identifying the adequate procedures and regarding the scientific pre-requisites expected by the control agencies, and on the other hand by patients who have to wait many years for these innovations to be made available. The development of these innovative therapies will thus question first, the way care and healthcare system shouldbe organised (including for their accessibility) and second, the legal regime and the bioethical principles to be applied for their implementation in the market.