English 
Greek Advanced Therapies (cell therapies, tissue engineering, gene therapy)
Currently, the area of advanced therapies is governed in Greece by the general legislation of the Oviedo Convention (art. 1, 3, 4, 13), the EU legislation (Regulations 1394/2007, 726/2004, Directives 2001/83, 2004/23), and specific provisions of national law implemented mostly by the National Drug Organization (EOF). The clinical use of these therapies should be distinguished clearly from their use in experimental procedures (clinical trials). Any such clinical use should be in compliance with the national law on Medical Ethics (l. 3418/2005), particularly with its article 25 on novel therapeutic applications, demanding as a binding legal prerequisite the existence of strong scientific evidence and risk/benefit assessment. Issues related to cross-border healthcare emerge also, here, as advanced therapies are offered in the Greece (mostly regarding cell therapies performed in private clinics). These are governed by the EU Directive 2011/24 (l. 4213/2013) with reference to specific patient rights.
Our services: Experts of our team contributed to to the drafting of the law on umbilical cord blood banking, the drafting of the Hellenic National Bioethics Commission’s Opinions and Reports to the Government on Umbilical Cord Blood Banking, Precision Medicine and Medical Tourism. Our experience includes also consulting services for the establishment of advanced therapies facilities, and an active presence in legal conferences, workshops and seminars in relevance, with original papers and interventions. Services we are offering are related to:
- Preparation of legally sound information documents and consent forms regarding patient access to advanced therapies
- Consultation on regulatory issues, particularly regarding professional liability of medical doctors, biologists and other experts involved in novel therapies