In December 2008, the EC Commission published its proposal for a directive on the standards of quality and safety of human organs intended for transplantation. The proposed directive will cover all phases of the human organ transplantation process – donation, procurement, testing, preservation, transport and use – and set out the basic quality and safety requirements needed in every transplant system. The proposed directive will also require the creation (or designation) of a competent national authority in each Member State to ensure compliance with the requirements of the directive and it will require the establishment of a tracing system to ensure that all organs can be traced by the relevant competent authorities from donation to reception. The EC Commission has stressed that traceability will not mean that the organ receiver will learn the names and further details of the donor, or vice versa.

The proposed directive is intended to encourage the exchange of organs between Member States (currently not common practice) and to prevent trade and trafficking in organs. A decision on the proposal by the European Parliament is currently pending.