1. 1 The EU’s efforts to provide high quality and safe Organ transplantation Anna Pavlou European Commission Health and Consumers Directorate General Public Health and Risk Assessment Directorate Health Law and International Unit C6 TAIEX Workshop on Organ Donation and Transplantation Medicine Collaboration in South Eastern Europe Croatia, February 2011

2. THE EU - A DIVERSE LANDSCAPE

3. 3 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 1 2 3

4. 4 DIRECTIVE 2010/53/EU (2010/45/EC) on standards of quality and safety of human organs intended for transplantation DIRECTIVE 2010/53/EU (2010/45/EC) on standards of quality and safety of human organs intended for transplantation Adopted: 7 July 2010 Transposition: 27 August 2012

5. Directive 2010/45/EC on Quality and Safety I.Scope, objectives and definitions II.Quality and safety of organs National Quality Programmes Organ procurement, procurement organisations, transplantation centres Transport of organs Organ and donor characterisation Traceability Reporting of serious adverse events and reactions III.Donor and recipient protection and donor selection and evaluation Unpaid and Voluntary Donation Quality and safety aspects of living donation Data protection IV.National oversight authority or authorities V.Organ Exchange with third countries VI.General provisions THE DIRECTIVE

6. 6 Scope and Objectives Ensures that human organs used for transplantation in the EU comply with the same minimum quality and safety requirements. Covers donation, procurement, testing, preservation, transport and transplantation of organs. Excludes blood and blood components, tissues and cells and organs of animal origin. THE PROPOSED DIRECTIVE

7. Proposed Directive on Quality and Safety a.Establishment of national oversight authority or authorities – Art.17 b.Establishment of National Quality Programmes – Art. 4 c.Ensuring traceability – Art. 10 d.Reporting of serious adverse events and reactions – Art. 11 e.Unpaid and Voluntary Donation – Art. 13 f.Ensuring a complete characterisation of the organ, in order for the transplant team to undertake the appropriate risk assessment – Art.7 + Annex THE DIRECTIVE

8. 8 THE ACTION PLAN

9. 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

10. 10 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 – through twinnings and peer reviews 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

11. Tools Projects Technical Working Groups Indicators Deceased Donation Living Donation THE ACTION PLAN

12. Recent Projects on Organ Donation and Transplantation EULID ETPOD EFRETOS ELIPSY EDD ODEQUS COORENOR ELPAT Conference Tender on Training transplant donor coordinators trainers TAIEX Workshops THE ACTION PLAN

13. ACTION PLAN DIRECTIVE 2008 2010-11 2013 2015 Adoption Proposal Adoption: 7.7.2010 Mid-term review Evaluation Transposition: 27.08.2012

14. 14 Thank you for your attention http://ec.europa.eu/health/blood_tissues_organs/organs/index_en.htm