The EU Standards Directive on human organ transplantation : a Maltese Law evaluation

Abstract

This paper discusses European Union Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. At the outset, the organ transplantation directive is introduced in the light of Maltese Medical Law regulating organ donation and transplantation. Next, the European Union’s legislative authority for adopting this Directive is set out. The salient innovative and pioneering features of the organ transplantation Directive are then briefly explained. As this Directive has to be transposed by Malta not later than 27 August 2012, the implications for transposition are considered so as to assist the Maltese authorities at identifying those measures which have to be addressed by them in the Directive’s transposition and subsequent implementation. This is because transposition requires not only the adoption of the Directive’s provisions into Maltese Law but also the taking of several other measures by the State of Malta and the competent authority to be designated for the implementation of the Directive at national level. The paper then considers certain unaddressed and unresolved matters in the Directive and concludes by making recommendations for adoption by the State of Malta in the transposition and implementation of the Directive on organ donation and transplantation stages into Maltese Law.