1. 1 EU Policy in the field of Organ Donation and Transplantation Media Seminar - EU Health Journalist Prize Brussels, 29 October 2009 Anna Pavlou European Commission Health and Consumers Directorate General Public Health and Risk Assessment Directorate Health Law and International Unit C6

2. 2 Legislative process in the EU Problem identification Open Consultation Impact Assessment Commission Proposal Co-decision procedure: Council + European Parliament EU POLICY ON SUBSTANCES OF HUMAN ORIGIN The steps towards the Commission Organ Proposals Statement by the Commission (2004) Questionnaire to Member States (2004) Open Consultation (2006) Commission Communication 2007 + problem identification document Council and EP Resolutions (dec.2007)+ (apr.2008) Commission proposals (dec.2008) => Action Plan + Directive => + Impact Assessment Co-decision: 2 readings

3. THE EU - A DIVERSE LANDSCAPE Source: CoE/ONT 1 2 2 2 2 2 1 = Eurotransplant 2 = Scandiatransplant 1 1 1 1 1 1

4. 4 ORGAN DONATION AND TRANSPLANTATION: POLICY ACTIONS AT EU LEVEL 10 PRIORITY ACTIONS (2009-2015) Increasing organ availability Make transplantation systems more efficient and accessible Improve quality and safety EU LEGAL FRAMEWORK Quality and Safety Requirements

5. 5 THE ACTION PLAN

6. 6 Action Plan on Strengthened Cooperation between Member States Promote the role of transplant donor coordinators in every hospital where there is a potential for organ donation Promote Quality Improvement Programmes in every hospital where there is a potential for organ donation Promote Living Donation Programmes Enhance the organisational models of organ donation and transplantation in the EU Member States Facilitate the interchange of organs between national authorities Improve knowledge and communication skills of health professionals and patients support groups on organ transplantation THE ACTION PLAN

7. Increase Organ Availability Enhance Efficiency and Accessibility of Transplantation Systems Quality and Safety CHALLENGESOBJECTIVES 1 full potential of deceased donation 2 living donation as complementary 3 Increase public awreness 4 support and guide TX Systems 5 improve quality and safety PRIORITY ACTIONS 1 transplant coordinators 2 quality improvement programmes 3 living donation programmes 4 communication skills of health professionals 5 information on citizens rights 6 enhance organisational models 7 EU-wide agreements 8 interchange of organs 9 evaluation of post transplant results 10 common accreditation system WGPROJECTS

8. 8 THE DIRECTIVE

9. Proposed Directive on Quality and Safety a.Establishment of national oversight authority or authorities b.Establishment of National Quality Programmes c.Ensuring traceability d.Reporting of serious adverse events and reactions e.Unpaid and Voluntary Donation f.Ensuring a complete characterisation of the organ, in order for the transplant team to undertake the appropriate risk assessment THE DIRECTIVE

10. 10 State of Play Council 1st Reading CZ Presidency Progress Report SW Presidency will move text forward European Parliament Miroslav Mikolasik (SL/EPP) Andres Perello Rodriguez (ES/S&D) Expected Outcome adoption under the ESP Presidency – June 2010 Entry into force Two years after adoption

11. ACTION PLAN DIRECTIVE 2008 2010-11 2013 2015 Adoption Proposal Adoption? Mid-term review Entry into force? Evaluation

12. 12 Thank you http://ec.europa.eu/health/index_en.htm