For many patients, organ transplantation represents the only life saving treatment available. There are currently 56,000 patients waiting for a suitable organ donor in the EU. It is estimated that every day 12 people die while waiting for transplantation. The Directive and Action Plan that the Commission proposed addresses 3 key challenges to save lives: improving the quality and safety of organs across Europe, increasing organ availability and making transplant systems more efficient and accessible. EU and Member States will strengthen their cooperation on organ donation and transplantation to provide high quality and safe transplantation systems that citizens and patients across Europe can rely on. The proposal for a Directive provides a clear legal framework for organ donation and transplantation in the European Union. It aims to minimise the risk for the organ transplant recipient, to improve and optimise the allocation of human organs across the European Union and to provide the transplant surgeon with the necessary information to make the best choices. The Action Plan with 10 priority actions addresses the 3 key challenges in organ donation and transplantation in Europe. The Action Plan aims to stimulate joint actions and facilitate coordination with Member States. This will be achieved through different mechanisms such as exchanging good practice or creating EU wide agreements on specific topics. The organ donation and transplantation EU health initiative is part of the Commission's Europe for Patients campaign.

The Impact Assessment on improving organ donation and transplantation across the European Union identifies the major policy options, in order to deal with the main challenges in this field and outlines the rationale for EU action. Four policy options for future EU action are analysed: continue current activities, establish a mechanism to strengthen coordination between Member States and introduce either a flexible or a stringent legal instrument on quality and safety of organs together with a method of cooperation. Economic, social and health impacts are analysed and the possible options for EU action are compared. The Impact Assessment concludes that an integrated approach is the best way to achieve the objectives in the area of organ donation and transplantation: strengthened cooperation between Member States underpinned by a flexible legal framework.

This report summarises the presentations and discussions at a Workshop-Hearing on the Quality and Safety of Organ Donation and Transplantation, held at the European Parliament in Brussels on Thursday 19th November 2009. The aim of the workshop was to exchange views on the Commission's 2008 proposal for a Directive of the European Parliament and of the Council on standards of quality and safety of human organs intended for transplantation (COM(2008) 818 final) and the associated Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States (COM(2008) 819/3).

In May 2007, the European Commission issued a communication relating to organ donation and transplantation. This made a number of proposals for actions which were designed to help increase the supply of donor organs across the EU. The two major elements were: first, the introduction of a directive aimed at setting standards for the quality and safety of organ donation and transplantation across the EU; and, second, the establishment of an action plan for closer cooperation between Member States in sharing experiences and best practice. This Report brings together evidence relating to the Commission's proposals and draws conclusions about their merits. It also sets out evidence received about a range of matters relating to organ donation which are not within Community competence but which are of central relevance to the shortage of organs for donation: the Organ Donation Taskforce's recent recommendations for the re-organisation of the health infrastructure in the UK; and the proposal, by the Chief Medical Officer for England, that current legislation in England should be changed in order to create a "presumed consent" or "opt-out" system for organ donation in place of the existing "opt-in" system. The Committee's conclusion is that the proposals set out in the Commission's communication would help to raise the numbers of organs available for transplantation as well as the overall safety and quality of those organs. The proposed directive should not be overly bureaucratic and should not inhibit the application of expert clinical judgement and informed patient choice.

Organ transplantation is a much-discussed subject, and the importance of living organ donation is increasing significantly. Yet despite all efforts, too few donor organs are available to help all patients in need. This book analyses whether the national legal regulations are also partly responsible for the organ shortage in the Member States of the European Union. In addition to a detailed analysis of the various national regulations, the main arguments in favour of and against legal restrictions on living organ donation are considered. Furthermore, the European Union’s authority is investigated, namely, whether it is entitled to establish statutory provisions for the Member States with respect to a harmonized regulation of living organ donation. Based on the results of the analysis, the author establishes a Best Practice Proposal for living organ donation.

The first holistic and thematic study of EU health law, and its implications, through its own internal logics.

Organ shortage is an ongoing problem in many countries. The needless death and suffering which have resulted necessitate an investigation into potential solutions. This examination of contemporary ethical means, both practical and policy-oriented, of reducing the shortfall in organs draws on the experiences of a range of countries. The authors focus on the resolution and negotiation of ethical conflict, examine systems approaches such as the 'Spanish model' and the US Breakthrough Collaboratives, evaluate policy proposals relating to incentives, presumed consent, and modifications regarding end-of-life care, and evaluate the greatly increased use of (non-heart-beating) donors suffering circulatory death, as well as living donors. The proposed strategies and solutions are not only capable of resolving the UK's own organ-shortage crisis, but also of being implemented in other countries grappling with how to address the growing gap between supply and demand for organs.