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European Union: Proposal on Organ Donation and Transplantation

(May 25, 2010) On May 19, 2010, the European Parliament approved a draft Directive on Standards of Quality and Safety of Human Organs Intended for Transplantation, initially proposed by the European Commission in August 2008. The Parliament, which adopted the proposal by 643 votes to 16 with 8 absentees, also endorsed an action plan proposed by the Commission on organ donation and transplantation for the period of 2009-2015. (EU Adopts New Rules on Organ Transplants, EURACTIV.COM, May 21, 2010, available at

The impetus for the adoption of the Directive was the growing list of patients in need of transplants due to a scant number of available organs – there are approximately 56,000 patients awaiting transplants; the expected mortality rate among them ranges from 15 to 30% Another factor in the decision to approve the draft is concern about the existing differing rules among the European Union Member States. In addition, as the Commission also noted, the limited number of organs is closely linked to increased trafficking of human organs by organized criminal groups. (Draft Directive, COM(2008) 818,
(last visited May 21, 2010).)

The draft Directive regulates the transplant of organs during all phases of transplantation, from donation, procurement, testing, preservation, and transport to use, and aims to achieve a two-fold goal: quality of organs and safety for patients. It excludes from its scope human tissue, cells, and blood products, as well as tissue and cells of animal origin.

Member States are required to designate a national authority to oversee transplantations and ensure correct and efficient implementation of the Directive. Some highlights of the Directive include:

  • introduction of common quality and safety standards governing the procurement, evaluation, and selection of donors;
  • introduction and operation of national programs to ensure the quality of overall performance and constant monitoring;
  • establishment of a tracing system from the donor to the recipient and vice versa, in an effort to avoid financial remuneration for organ donation, trafficking of humans, and trade in organs;
  • anonymity of both donors and recipients;
  • measures to protect the health of living donors;
  • creation of a European database that will contain information about organs ready for transplantation and potential deceased and living donors; and
  • creation of an EU-wide certification system to ensure that organs have been obtained through legal means. (Id.)