On 8 December 2008 the Commission adopted a proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation and a 10 point Action Plan to work with Member States on strengthening organ donation and transplantation systems in Europe. The Directive and Action Plan address three key challenges: improving the quality and safety of organs across Europe, increasing organ availability and making transplant systems more efficient and accessible. A summary of the impact assessment of this new proposal is available

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Prior to the proposal for a Directive, the European Commission adopted a a Communication in May 2007 in response to the results of an earlier open consultation. The annex to the Communication provided a comprehensive impact assessment (see the short summary ) identifying the major policy challenges in respect to organ donation and transplantation.