EU Policy in the field of Organ Donation and

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EU Policy in the field of Organ Donation and Powered By Docstoc
					Media Seminar - EU Health Journalist Prize
Brussels, 29 October 2009




 EU Policy in the field of Organ
 Donation and Transplantation


                                                             Anna Pavlou
                                                    European Commission
                                Health and Consumers Directorate General
                            Public Health and Risk Assessment Directorate
                                      Health Law and International Unit C6
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                                            EU POLICY ON SUBSTANCES OF
                                                   HUMAN ORIGIN

                                   The steps towards the Commission
 Legislative process in the EU
                                            Organ Proposals

                                 • Statement by the Commission (2004)
• Problem identification
                                 • Questionnaire to Member States (2004)
• Open Consultation
                                     • Open Consultation (2006)
• Impact Assessment
                                 • Commission Communication 2007 +
                                        problem identification document

                                 • Council and EP Resolutions
                                     •(dec.2007)+ (apr.2008)

                                 • Commission proposals (dec.2008)
                                     => Action Plan + Directive
• Commission Proposal
                                     => + Impact Assessment
• Co-decision procedure:
                                 • Co-decision: 2 readings
Council + European Parliament                                        2
THE EU - A DIVERSE LANDSCAPE

        2                                                 1 = Eurotransplant

                                                      2
                                                          2 = Scandiatransplant
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Source: CoE/ONT
                             ORGAN DONATION AND
                             TRANSPLANTATION: POLICY
                             ACTIONS AT EU LEVEL




           Increasing
             organ
           availability


               Make
          transplantation
           systems more
              efficient
          and accessible
                                         Quality and
                                           Safety
          Improve quality               Requirements
               and
              safety

10 PRIORITY ACTIONS (2009-2015)      EU LEGAL FRAMEWORK 4
THE ACTION PLAN



                  5
                                                   THE ACTION PLAN


 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      6
                                                                                               1 transplant coordinators
                                             1 full potential of                               2 quality improvement programmes
               Increase                      deceased donation
                Organ                        2 living donation                                 3 living donation programmes
               Availability                  as complementary                                  4 communication skills
                                             3 Increase public awreness                        of health professionals
                                                                                               5 information on citizens rights




                                                                            PRIORITY ACTIONS
CHALLENGES




                Enhance


                                OBJECTIVES
                Efficiency
                                                                                               6 enhance organisational models
                   and                       4 support and guide                               7 EU-wide agreements
             Accessibility of                TX Systems
                                                                                               8 interchange of organs
             Transplantation
                 Systems


                 Quality                                                                       9 evaluation of post transplant
                  and                        5 improve quality and safety                      results
                 Safety                                                                        10 common accreditation system



                                                                                                WG                 PROJECTS
THE DIRECTIVE



                8
                                                         THE DIRECTIVE



              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
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


                                                   10
                                                  ORGAN DONORS RATES
                                                   Per million population
                                                          2015?



             ACTION PLAN
                                      < 11 ppm
                                      < 11 ppm
                                      11-20 ppm
                                      11-20 ppm
                                      20-30 ppm
                                      20-30 ppm
                                      > 30 ppm
                                      > 30 ppm




Evaluation
Mid-term review

 Adoption                                         Entry into force?
            ORGAN DONORS RATES
             Per million population
                                                           Adoption?
                     2004
                                                           Proposal

< 11 ppm
< 11 ppm

11-20 ppm
11-20 ppm

20-30 ppm
20-30 ppm
> 30 ppm
> 30 ppm
                                                  DIRECTIVE
        Thank you




http://ec.europa.eu/health/index_en.htm
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