Bioethics and European Union: the Advanced Therapy. Medicinal Products’ Case

Authors: Aurélie Mahalatchimy


Advanced Therapy Medicinal Products (ATMP) are medicinal products which are based on human genes, cells and tissues. They are completely framed by European Union Law. They are covered by the European pharmaceutical general legislation and by a lex specialis: the regulation (EC) N°1394/2007 on ATMP. This legal framework has been accompanied with the adoption of many guidelines related to ATMP. Furthermore, ATMP raised important ethical questions which can not be ignored: human cloning, research on embryonic stem cells, chimeras … They principally come from the legal difference between the human body and its elements and the products derived from them or containing them.