- Directive on standards of quality and safety of human organs for transplantation (Directive 2010/53/EU). It applies to donation; procurement ; testing; characterisation; transport; transplantation of organs. It sets out a common framework on quality and safety standards for organs of human origin intended for transplantation into the human body. It also aims to protect donors and optimise exchanges between Member States and third countries. It is to bear in mind that the following areas are out of the scope of the Directive: consent systems for organ donation (opt-in vs. opt-out); waiting lists (access to healthcare); criteria for organ allocation; and legislation around brain death. These areas remain a national competence.
- Action Plan on Organ Donation and Transplantation for the period 2009-2015(Commission Communication COM(2008) 819), setting out 10 priority actions grouped under three challenges: increasing organ availability; enhancing efficiency and accessibility of transplantation systems; improving quality and safety. The action plan aim is to strengthen cooperation between Member States in organ donation and transplantation. The Action Plan tools are:
As part of the mid-term review of the Action Plan, the following documents have been prepared: the external study; the Council Conclusions; and the Commission staff working document. The final review of the Action Plan on Organ Donation and Transplantation is foreseen for 2016.
- European Commission Implementing Directive laying down information procedures for the exchange, between Member States, of human organs intended for transplantation (Directive 2012/25/EU). This Directive lays down common procedures for transmitting information on the exchange of human organs between diverse stakeholders, whether in the context of organ and donor characterisation, the traceability of organs or the reporting of serious adverse events and reactions.