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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

1

2

2

2

2

2 1 = Eurotransplant

2 = Scandiatransplant

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1

1

1

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

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