Acta Universitatis Danubius. Juridica, Vol 7, No 2 (2011)

Abstract

Objectives: The article elaborates on the intricacies brought on the Romanian Law by the adoption, on 7 July 2010, of Directive 2010/45/EU of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation, raising for the Romanian legal system the question of rapidly adapting its regulations and procedures to the newly introduced European standards, as well as the question of harmonizing its essential legislation by transposing Directive 2010/45/EU provisions into national law. Prior Work: Liability of Public Administration for damages caused by unsafe transplant procedures represents one of the major themes, in the recent specialized literature.The problematic ofinformed consent to organ donations, as well as that of organ traceability represents an interesting, though insufficiently explored and exploited issue, in contemporary Romanian Law. Approach: The author applies, as research method, the analysis of jurisprudence, doctrinal writing and legal provisions in force referring to the problematic of the human organs transplant and donations. The paper also discuses the text of Directive 2010/45/EU on standards of quality and safety of human organs intended for transplantation. Results: The “opting-in – opting out” dichotomy is discussed, as common standard for informed consent in the field of organ donations. The author also formulates de lege ferenda proposals. Implications: The paper interests legal practitioners confronted with the problematic of human organs donations, law students, as well as jurists specialized in Consumer Law and Administrative Law, since the problematic of organ transplantation also reverberates on the protection of the consumers of medical services. Value: The analysis insists on the degree of compliance of national law to the EU’s regulations when removing disparities on donor’s consent procedure or on standards of safety related to the transport of human organs. The paper is also enriched by a presentation of the new European standards on the National Register of living donors and on the National Data bases on serious adverse events.