ORGAN DONATION AND ORGAN DONATION AND TRANSPLANTATIONTRANSPLANTATION

in the EUROPEAN UNIONin the EUROPEAN UNION

Alessandro Nanni CostaItalian National Transplant Centre

WHAT IS ORGAN TRANSPLANTATION?WHAT IS ORGAN TRANSPLANTATION?

kidneysheart

liver

lung

pancreas

ORGANS

An organ transplant is a surgical operation in which a failing or damaged organ in the human body is removed and replaced with a functioning one. The donated organ may be from a deceaseddonor, a living donor, or an animal. In some cases an artificial organ is used.

THE PROCESS STARTS WITH A GIFTTHE PROCESS STARTS WITH A GIFT

A gift to the recipients and their families

AN UNDENIABLE ADVANTAGE FOR PATIENTS AN UNDENIABLE ADVANTAGE FOR PATIENTS

In some cases (heart, liver, lung) organ transplantation is a life saving treatment

But even for kidney, for which a replacement therapy is available, the quality of life of patients drammatically improves after transplantation

DONOR MANAGEMENT(CLINICAL, LOGISTICAL, DECISION MAKING ASPECTS)

Identification

�

Diagnosis

�

Referral

�

First A

sessment

�

Maintenance

�

Family interview

�

Typing

�

Recipient

selection

�

Second

 assessment

�

Organ

 recovery

�

Transplant

�

Follow‐up

�

RECIPIENT MANAGEMENTRECIPIENT MANAGEMENT(CLINICAL, LOGISTICAL, DECISION MAKING ASP(CLINICAL, LOGISTICAL, DECISION MAKING ASPECTSECTS))

Diagnosis

�

Indication for transplant

�

Clinical assessment

�

Admission/treatm

ent

�

Periodic testing

�

Waitlisting

�

Immunol Assessm

ent

�

Selection for tx

�

Summoning

�

Preparation�

Transplant�

Follow‐up

�

TRANSPLANTED TRANSPLANTED PATIENT PATIENT

MANAGEMENTMANAGEMENT

BUT A VERY COMPLEX PROCESSBUT A VERY COMPLEX PROCESS……

A COMPLEX JIGSAW PUZZLE INVOLVING A COMPLEX JIGSAW PUZZLE INVOLVING LOGISTICS AND ORGANIZATIONLOGISTICS AND ORGANIZATION

ACTIVITY IN EUROPEACTIVITY IN EUROPE

4 …shall contribute to the achievement of the objectives referred to in this Article through adopting in order to meet common safety concerns:

(a) Measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member States from maintaining or introducing more stringent protective measures.

Article168 (4) (a) Lisbon Treaty

EUROPEAN LEGAL BASISEUROPEAN LEGAL BASIS

Conference on Conference on Safety and Quality Safety and Quality in Organ Donation in Organ Donation

and Transplantationand Transplantationin the European in the European

UnionUnion

COMMUNICATION BY THE EC(2004)

EUROBAROMETER(2003)

PUBLIC CONSULTATION

(2006)

EUROBAROMETER(2007)

EU DIRECTIVE 2010/53/EU

EUROPEAN LEGISLATION IN THIS FIELDEUROPEAN LEGISLATION IN THIS FIELD

ACTION PLAN

INCREASING INCREASING ORGAN ORGAN

AVAILABILITYAVAILABILITY

MAKE MAKE TRANSPLANTATION TRANSPLANTATION

SYSTEMS MORE SYSTEMS MORE EFFICENT AND EFFICENT AND ACCESSIBLEACCESSIBLE

IMPROVE IMPROVE QUALITY AND QUALITY AND

SAFETYSAFETY

EUROPEAN DIRECTIVE

QUALITY AND QUALITY AND SAFETY SAFETY

REQUIREMENTSREQUIREMENTS

DIRECTIVE AND ACTION PLANDIRECTIVE AND ACTION PLAN

INCREASE ORGAN

AVAILABILITY

ENHANCE EFFICIENCY AND ACCESSIBILITY OF

TRANSPLANTATION SYSTEMS

QUALITY AND

SAFETY

CHA

LLEN

GES

CHA

LLEN

GES

OBJ

ECTIV

ESO

BJEC

TIVES

PRIO

RITY

AC

TION

SPR

IORI

TY A

CTIO

NS

1. Full potential o deceased donation2. Living donation as complementary3. Increase public awareness

4. Support and guide TX systems

5. Improve quality and safety

1. Transplant coordinators2. Quality improvement programmes3. Living donation programmes4. Communication skills of health professionals5. Information on citizens right

6. Enhance organizational models7. EU-wide agreements8. Interchange of organs

9. Evaluation of post transplant results10. Common accreditation system

WORKING GROUPSWORKING GROUPS PROJECTSPROJECTS

WORKING GROUPS and HEALTH PROGRAM: WORKING GROUPS and HEALTH PROGRAM: a close collaboration a close collaboration

HEALTH PROGRAMMEHEALTH PROGRAMMEPROJECTS and JOINT ACTIONSPROJECTS and JOINT ACTIONS

FUNDING PROGRAMS:Public Health 2006-2008

RUNNING PROJECTSRUNNING PROJECTS

COORENOR project:PUBLIC HEALTH 2009

MODE Joint Action :PUBLIC HEALTH 2010

SOHOV&S project:PUBLIC HEALTH 2009

ACCORD Joint Action :PUBLIC HEALTH 2011

OUTCOMESOUTCOMES

Networking

Sharing of quality and safety practices

Sharing of possible solutions for common problems

WHAT WE EXPECTWHAT WE EXPECT

Improvement of overall quality and safety of transplants in EU

Clear identification of Competent Authorities in each Member State

A better traceability for international exchanges

CONCLUSIONSCONCLUSIONS

Transplantation requires- the building of a network- the development of new skills- the enhancement of research

This systems needs rules and skills

EU actions and Health program have laid the grounds for regulation and increase of quality in the interest of patients