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Transcript of 1 EU Policy in the field of Organ Donation and Transplantation Media Seminar - EU Health Journalist...
1
EU Policy in the field of Organ Donation and Transplantation
Media Seminar - EU Health Journalist Prize Brussels, 29 October 2009
Anna PavlouEuropean Commission
Health and Consumers Directorate GeneralPublic Health and Risk Assessment Directorate
Health Law and International Unit C6
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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
THE EU - A DIVERSE LANDSCAPE
Source: CoE/ONT
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2
2
2
2
2 1 = Eurotransplant
2 = Scandiatransplant
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1
1
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ORGAN DONATION AND TRANSPLANTATION: POLICY ACTIONS AT EU LEVEL
10 PRIORITY ACTIONS (2009-2015)
Increasing organ
availability
Make transplantation systems more
efficientand accessible
Improve quality and
safety
EU LEGAL FRAMEWORK
Quality and Safety
Requirements
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THE ACTION PLANTHE ACTION PLAN
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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
Increase Organ
Availability
Enhance Efficiency
and Accessibility of Transplantation
Systems
Quality and
Safety
CH
AL
LE
NG
ES
CH
AL
LE
NG
ES
OB
JEC
TIV
ES
OB
JEC
TIV
ES
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
PR
IOR
ITY
AC
TIO
NS
PR
IOR
ITY
AC
TIO
NS
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
WGWG PROJECTSPROJECTS
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THE DIRECTIVETHE 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
THE DIRECTIVE
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State of PlayCouncil
1st ReadingCZ Presidency Progress ReportSW 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 forceTwo years after adoption
ORGAN DONORS RATESPer million population
2015?
ORGAN DONORS RATESORGAN DONORS RATESPer million populationPer million population
2015?2015?
11-20 ppm11-20 ppm
20-30 ppm20-30 ppm
> 30 ppm> 30 ppm
< 11 ppm< 11 ppm
ORGAN DONORS RATESPer million population
2004
ORGAN DONORS RATESORGAN DONORS RATESPer million populationPer million population
20042004
11-20 ppm11-20 ppm
20-30 ppm20-30 ppm
> 30 ppm> 30 ppm
< 11 ppm< 11 ppm
ACTION PLAN
DIRECTIVE2008
2010-11
2013
2015
Adoption
ProposalAdoption?
Mid-term review
Entry into force?
Evaluation
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Thank you
http://ec.europa.eu/health/index_en.htm