Organs

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Legislation

The legal framework defining the standards for organ transplantation is set out in Directive 2010/53/EU, also referred to as the European Organs Directive.

The Directive lays down the quality and safety standards for organs. It covers all steps in the transplant process from donation, through procurement, testing, handling to distribution.

To help implement this basic act, the Commission proposed and adopted, in close collaboration with EU national authorities, Commission Directive 2012/25/EU regarding the information procedures for exchange of human organs intended for transplantation, between EU countries.

The Commission's proposal for the Organs Directive was accompanied by an Impact Assessment. Resolution 2007/2210, Council Conclusions No 15332/07 SAN on organ donation and transplantation, the Communication from the Commission COM (2007) 275 and the Consultation on Organ Donation and Transparency that lay the groundwork for the existing legislation.

Guidelines

The European Commission collaborates closely with expert bodies such as the  Council of Europe (CoE) and the European Centre for Disease Prevention and Control (ECDC) in the development of practical guidelines that support transplant centres and procurement organisations with the implementation of this binding legislative framework.

• The Council of Europe (CoE) regularly reviews and updates technical requirements in its Guide to the quality and safety of Organs for Transplantation. In addition, it has published a Recommendation on organ trafficking.
• The ECDC prepares risk assessments and preparedness plans whenever epidemiological outbreaks are of relevance for blood, tissues, cells and organs. Most recently ECDC has provided input on:
  • Ebola
  • Hepatitis A
  • West Nile Virus
  • Zika

Coordination and implementation

National Competent Authorities (CAs) are in charge of the implementation of the requirements established in EU legislation. The European Commission holds regular meetings with them to facilitate communication and the exchange of best practices, as well as to reach a common understanding on the implementation of the Directives.

Periodic surveys, completed by the CAs, allow the European Commission to draft reports on the current  implementation status of the legislation.

• Report on the implementation of the legislation
• Meeting Minutes

Occasionally, the EU National Competent Authorities adopt a statement on a topic of common interest or concern:

• Statement on Organ Donation and Transplantation and the COVID-19 pandemic
• Statement on a proposed concept of Global Kidney Exchange

Action plan

The European Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States  assists EU countries in addressing the shortage of organs, enhancing transplant systems and improving the quality and safety of transplant products. It has set a common direction for EU countries to strengthen their national transplant activities and served as the basis for many EU-funded actions. Over its period of implementation, 2009-2015, EU countries increased activities by 4,600 additional transplants per year.

• Mid-term review of the Action Plan and accompanying study
• Final assessment of the Action Plan and accompanying study
• Other documents connected to the Action Plan

EU-funded actions

The European Commission provides funding for Actions in the area of SoHO through the Third EU Health Program (2014-2020) and previous EU Health Programmes, mainly in the form of projects or joint actions with national authorities. In addition, the European Parliament has proposed to fund some pilot projects in this field.

Actions aim at supporting the EU mandate on safety and quality, but can also serve to promote other policy priorities, such as improving the availability of SOHO or the efficiency of the health systems that support donation and supply. Some recent examples include:

• Joint Action FOEDUS – Facilitating the exchange of organs donated in EU Member States
• EDITH - Project focusing on different organ donation and transplantation practices
• EUDONORGAN - Training and Social Awareness for Increasing Organ Donation in the European Union and Neighbouring Countries
• COORENOR - Coordinating a European Initiative among National Organisations for Organ Transplantation
• ODEQUS - European Quality System Indicators and methodology on Organ Donor
• Joint Action ACCORD - Achieving Comprehensive Coordination in Organ Donation throughout the European Union
• Joint Action MODE - Mutual Organ Donation and Transplantation Exchanges: Improving and developing deceased organ donation and transplantation programmes
• EFRETOS - European Framework for the Evaluation of Organ Transplant
• DOPKI - Improving the knowledge and practice of Organ Donation
• ALLIANCE-O - European Group for Cooperation of National Research Programmes on Organ Donation and Transplantation
• ETPOD - European Training Programme on Organ Donation
• ELIPSY - European Living Donor Psychological Follow-up
• EULOD - Living Organ Donation in Europe.