Vom 15. November 2007
Deutscher Bundestag Drucksache 16/7192
16. Wahlperiode 15. 11. 2007
Beschlussempfehlung und Bericht
des Ausschusses für Gesundheit (14. Ausschuss)
zu der Unterrichtung durch die Bundesregierung
– Drucksache 16/6389 Nr. 1.10 –
Mitteilung der Kommission an das Europäische Parlament und den Rat
Organspende und -transplantation: Maßnahmen auf EU-Ebene
(inkl. 9834/07 ADD 1)
KOM (2007) 275 endg.; Ratsdok. 9834/07
A. Problem
Die Mitteilung der Europäischen Kommission über Organspende und -trans-
plantation greift die Rechtsgrundlage des Artikels 152 Abs. 4 Buchstabe a des
EG-Vertrages (EGV) auf, der das Europäische Parlament und den Rat ermäch-
tigt, harmonisierte Maßnahmen auf der Grundlage des Mitentscheidungsver-
fahrens gemäß Artikel 251 EGV zu treffen, um hohe Qualitäts- und Sicher-
heitsstandards für Organe und Substanzen menschlichen Ursprungs festzule-
gen. Die Europäische Kommission hat in der Mitteilung zentrale Handlungs-
felder hinsichtlich Organspende und -transplantation auf der Grundlage des im
Juni 2006 durchgeführten Konsultationsverfahrens vorgelegt. Mit Blick auf
das hohe Sicherheits- und Qualitätsniveau des Transplantationswesens in
Deutschland und die zum Teil sehr unterschiedlichen kulturellen, rechtlichen
und organisatorischen Gegebenheiten in der Transplantationsmedizin der einzel-
nen Mitgliedstaaten stellt sich die Frage nach der Angemessenheit vorgeschla-
gener Maßnahmen sowie nach den möglichen Auswirkungen ihrer Umset-
zung auf das Transplantationswesen in Deutschland.
B. Lösung
Kenntnisnahme der Unterrichtung und Annahme eines Entschließungsantrags.
Die Bundesregierung wird aufgefordert, im Rahmen des europäischen Diskus-
sionsprozesses dafür Sorge zu tragen, dass nur solche Regelungen getroffen
werden, die das hohe Sicherheits- und Qualitätsniveau im Bereich der Organ-
spende und -transplantation in Deutschland nicht beeinträchtigen und die mit
dem Subsidiaritätsprinzip nach Artikel 152 Abs. 5 Satz 2 EGV vereinbar sind.
In Kenntnis der Unterrichtung Annahme einer Entschließung mit den
Stimmen aller Fraktionen
Drucksache 16/7192 – 2 – Deutscher Bundestag – 16. Wahlperiode
C. Alternativen
Kenntnisnahme der Vorlage und gegebenenfalls Annahme einer alternativen
Entschließung.
D. Kosten
Wurden im Ausschuss nicht erörtert.
Deutscher Bundestag – 16. Wahlperiode – 3 – Drucksache 16/7192
Beschlussempfehlung
Der Bundestag wolle beschließen,
in Kenntnis der Unterrichtung auf Drucksache 16/6389 Nr. 1.10 folgende Ent-
schließung anzunehmen:
„I. Der Deutsche Bundestag stellt fest:
Die Europäische Kommission hat am 30. Mai 2007 eine Mitteilung an das Euro-
päische Parlament und den Rat zu Organspende und -transplantationsmaßnah-
men auf EU-Ebene vorgelegt. In der Mitteilung stellt die Europäische Kommis-
sion Initiativen auf Gemeinschaftsebene vor, um die Probleme in Europa im Zu-
sammenhang mit Transplantationsrisiken, Organmangel und illegalem Organ-
handel zu bewältigen. Folgende Hauptaktionsschwerpunkte wurden vorgestellt:
– Aktionsplan zur verstärkten Zusammenarbeit zwischen den Mitgliedstaaten
im Bereich der Organspende und -transplantation, um gemeinsame Ziele zu
ermitteln und zu entwickeln, für die ein gemeinschaftliches Vorgehen erfor-
derlich ist,
– Vorschlag der Europäischen Kommission zu einem EU-Rechtsinstrument
über Qualität und Sicherheit von Organspende und -transplantation und
– weiterhin aufmerksame Verfolgung aller Entwicklungen im Bereich des ille-
galen Organhandels sowohl in der EU als auch weltweit.
Der Deutsche Bundestag nimmt die Mitteilung der Europäischen Kommission
an das Europäische Parlament und den Rat Organspende und -transplantations-
maßnahmen auf EU-Ebene zur Kenntnis und teilt die Auffassung der Euro-
päischen Kommission, dass vor allem der Organmangel ein grundlegendes
Problem der transplantationsmedizinischen Versorgung in den EU-Mitglied-
staaten ist.
Der Deutsche Bundestag begrüßt die Initiative der Europäischen Kommission,
einen Aktionsplan mit Maßnahmen zum Bereich Organspende und -transplan-
tation vorzulegen; dabei sind die Sicherstellung eines hohen Gesundheits-
schutzniveaus für alle Patientinnen und Patienten in ganz Europa sowie die
Umsetzung von Maßnahmen zur Behebung des Organmangels in Europa von
Priorität.
Der Deutsche Bundestag stimmt mit der Europäischen Kommission darin über-
ein, dass innerhalb Europas höchst unterschiedliche kulturelle, rechtliche und
organisatorische Gegebenheiten vorliegen und die Realisierung eines hohen
Qualitäts- und Sicherheitsniveaus in allen europäischen Mitgliedstaaten bei der
Organspende und -transplantation zum Wohle der schwerkranken Patientinnen
und Patienten gefördert und weiter vorangetrieben werden muss.
Der Deutsche Bundestag weist darauf hin, dass die Organspende und -trans-
plantation mit komplexen Fragen von ethischer Tragweite verbunden ist und in
den Mitgliedstaaten aufgrund der jeweiligen kulturellen, rechtlichen und orga-
nisatorischen Gegebenheiten unterschiedlich behandelt wird.
Er begrüßt den Vorschlag eines Aktionsplans zur verstärkten Zusammenarbeit
zwischen den Mitgliedstaaten im Bereich der Organspende und -transplanta-
tion, um vor allem die Mitgliedstaaten zu unterstützen, die nicht über eine aus-
reichende transplantationsmedizinische Versorgung verfügen und unterstützt
den gegenseitigen Erfahrungsaustausch über Maßnahmen zur Erhöhung der
Organspendebereitschaft sowie über die Organisation der Organspende und
-transplantation in den jeweiligen Mitgliedstaaten, um die Verfügbarkeit von
Drucksache 16/7192 – 4 – Deutscher Bundestag – 16. Wahlperiode
Organen und die Leistungsfähigkeit und Zugänglichkeit der Transplantations-
systeme zu erhöhen und eine gerechte, nur nach medizinischer Indikation erfol-
gende Organallokation sicherzustellen.
Der Deutsche Bundestag stellt fest, dass das Transplantationswesen in Deutsch-
land, wie in anderen Mitgliedstaaten mit etablierten Transplantationssystemen,
auf einem hohen Sicherheits- und Qualitätsniveau ist und verweist auf den Arti-
kel 152 Abs. 5 Satz 2 des EG-Vertrages, wonach die einzelstaatlichen Regelun-
gen über die Spende oder die medizinische Verwendung von Organen unbe-
rührt bleiben.
II. Der Deutsche Bundestag bittet die Bundesregierung, den europäischen
Diskussionsprozess konstruktiv zu begleiten und darauf hinzuwirken, dass
1. bei den Beratungen über einen europäischen Rechtsrahmen für Qualität und
Sicherheit menschlicher Organe auf der Grundlage von Artikel 152 Abs. 4
Buchstabe a EGV keine europäischen Regelungen getroffen werden, die
letztlich die notwendige Versorgung der auf eine Organtransplantation ange-
wiesenen Patienten beeinträchtigen können oder die mit dem Subsidiaritäts-
prinzip in Artikel 152 Abs. 5 Satz 2 EGV nicht vereinbar sind,
2. die deutschen Erfahrungen bei den Beratungen über die Qualität und Sicher-
heit im Bereich der Organspende und -transplantation eingebracht werden
mit dem Ziel, europaweit ein hohes Sicherheits- und Qualitätsniveau zu er-
reichen,
3. die einzelstaatlichen gesetzlich-ethischen Regelungen über die Spende von
Organen unberührt bleiben.“
Berlin, den 14. November 2007
Der Ausschuss für Gesundheit
Dr. Martina Bunge
Vorsitzende
Dr. Konrad Schily
Berichterstatter
gliedstaaten, um die Verfügbarkeit von Organen und die
Leistungsfähigkeit und Zugänglichkeit der Transplantations-
systeme zu erhöhen, sowie Bekämpfung des illegalen Organ-
handels.
schaffen und dafür zu sorgen, dass die einzelstaatlichen ge-
setzlich-ethischen Regelungen über die Organspende durch
etwaige neue Regelungen auf EU-Ebene unberührt blieben.
Die Fraktion der FDP wies ergänzend darauf hin, dass sie
das Anliegen der Euroäischen Kommission teile, die Mög-
lichkeit der Lebendspende zu erweitern, dies aber im natio-
nalen Rahmen zu regeln sei.
Berlin, den 14. November 2007
Dr. Konrad Schily
Berichterstatter
Deutscher Bundestag – 16. Wahlperiode – 5 – Drucksache 16/7192
Bericht des Abgeordneten Dr. Konrad Schily
I. Überweisung
Die Mitteilung der Kommission zu Organspende und -trans-
plantation – KOM (2007) 275 endg.; Ratsdok. 9834/07 –
wurde mit Drucksache 16/6389 Nr. 1.10 vom 19. Septem-
ber 2007 gemäß § 93 Abs. 1 GO-BT dem Ausschuss für
Gesundheit zur Beratung überwiesen.
II. Wesentlicher Inhalt der Vorlage
Die Mitteilung der Kommission über Organspende und -trans-
plantation greift die Rechtsgrundlage des Artikels 152 Abs. 4
Buchstabe a EGV auf, der das Europäische Parlament und den
Rat ermächtigt, harmonisierte Maßnahmen auf der Grund-
lage des Mitentscheidungsverfahrens gemäß Artikel 251
EGV zu treffen, um hohe Qualitäts- und Sicherheitsstandards
für Organe und Substanzen menschlichen Ursprungs fest-
zulegen. In der Mitteilung werden die Initiativen auf Ge-
meinschaftsebene vorgestellt, die die Europäische Kommis-
sion in Bezug auf die Organspende und -transplantation in
Europa zu ergreifen beabsichtigt: Festlegung eines Qualitäts-
und Sicherheitsrahmens für Organspende und -transplanta-
tion, Förderung der Zusammenarbeit zwischen den Mit-
III. Beratungsverlauf und Beratungsergebnis
Der Ausschuss für Gesundheit hat die Vorlage in seiner
63. Sitzung am 10. Oktober 2007 und in seiner 67. Sitzung
am 14. November 2007 beraten. Die Fraktionen der CDU/
CSU und SPD brachten in der abschließenden Beratung auf
Ausschussdrucksache 16(14)0312 den in der Beschluss-
empfehlung wiedergegebenen Entschließungsantrag ein,
dem die Fraktionen FDP, DIE LINKE. und BÜNDNIS 90/
DIE GRÜNEN beigetreten sind. Im Ergebnis der Beratun-
gen empfiehlt der Ausschuss in Kenntnis der Unterrichtung
durch die Bundesregierung mit den Stimmen aller Fraktio-
nen, die in der Beschlussempfehlung wiedergegebene Ent-
schließung anzunehmen.
Alle Fraktionen äußerten übereinstimmend die Auffassung,
dass mit Blick auf die Bundesrepublik Deutschland eine
EU-Richtlinie ebenso wie eine gesetzliche Regelung auf eu-
ropäischer Ebene zum Thema Organtransplantation nicht
erforderlich sei. Man sei in erster Linie daran interessiert,
die Qualitäts- und Sicherheitsstandards, die in Deutschland
bereits erreicht worden seien, zu erhalten. Es gehe darum,
dem Subsidiaritätsprinzip in dieser Frage Geltung zu ver-
Deutscher Bundestag – 16. Wahlperiode – 7 – Drucksache 16/7192
Anlage
RAT DER
EUROPÄISCHEN UNION
Brüssel, den 4. Juni 2007 (13.06)
(OR. fr)
9834/07
SAN 108
ÜBERMITTLUNGSVERMERK
Absender: Herr Jordi AYET PUIGARNAU, Direktor, im Auftrag des
Generalsekretärs der Europäischen Kommission
Eingangsdatum: 31. Mai 2007
Empfänger: der Generalsekretär/Hohe Vertreter, Herr Javier SOLANA
Betr.: Mitteilung der Kommission an das Europäische Parlament und den Rat
Organspende und -transplantation: Massnahmen auf Eu-Ebene
Die Delegationen erhalten in der Anlage das Kommissionsdokument - KOM(2007) 275 endgültig
Anl.: KOM(2007) 275 endgültig
Drucksache 16/7192 – 8 – Deutscher Bundestag – 16. Wahlperiode
KOMMISSION DER EUROPÄISCHEN GEMEINSCHAFTEN
Brüssel, den 30.5.2007
KOM(2007) 275 endgültig
MITTEILUNG DER KOMMISSION
AN DAS EUROPÄISCHE PARLAMENT UND DEN RAT
ORGANSPENDE UND -TRANSPLANTATION: MASSNAHMEN AUF EU-EBENE
{SEK(2007) 704}
{SEK(2007) 705}
Deutscher Bundestag – 16. Wahlperiode – 9 – Drucksache 16/7192
1. EINLEITUNG
In den letzten 50 Jahren hat sich die Organtransplantation weltweit etabliert und
Hunderttausenden von Patienten ungeheuren Nutzen gebracht.
Organspende und –transplantation sind heikle und komplexe Fragen von ethischer Tragweite,
deren Ausbau der umfassenden gesellschaftlichen Mitwirkung bedarf. In verschiedenen
Aspekten werden diverse Aspekte je nach kulturellen, rechtlichen, administrativen und
organisatorischen Gegebenheiten unterschiedlich behandelt.
Die Zahl der Transplantationen menschlicher Organe ist in den letzten Jahrzehnten ständig
angestiegen. Mittlerweile stellt die Organtransplantation die kostengünstigste Behandlung bei
Nierenversagen im Endstadium dar; bei Leber-, Lungen- und Herzversagen ist sie zurzeit die
einzige Behandlungsmöglichkeit.
Durch die hervorragenden Ergebnisse, die mit Transplantationen in Bezug auf gewonnene
Lebensjahre und Verbesserung der Lebensqualität erzielt wurden, haben sich die Indikationen
dieser Therapien vervielfacht. Transplantationsverfahren werden immer noch weiter
entwickelt und können in Zukunft praktische Therapiemöglichkeiten für weitere bisher
unbehandelbare Erkrankungen bieten.
Der therapeutische Einsatz von Organen bringt jedoch auch ein Risiko der
Krankheitsübertragung mit sich. Jedes Jahr wird eine Reihe von Organen unter den EU-
Mitgliedstaaten ausgetauscht. Grenzübergreifender Austausch bedeutet, dass die
Transplantationsverfahren von Krankenhäusern oder Ärzten durchgeführt werden, für die
unterschiedliche Rechtsordnungen gelten.
Andererseits beeinträchtigt der Organmangel die Transplantationsprogramme in hohem Maße.
Beinahe 40 000 Patienten stehen zurzeit in Europa auf den Wartelisten. Die
Sterblichkeitsraten während der Wartezeit für eine Herz-, Leber- oder Lungentransplantation
betragen in der Regel zwischen 15 und 30 %. Innerhalb der EU ist die Rate der verstorbenen
und lebenden Spender höchst unterschiedlich. Diese Unterschiede sind nicht leicht zu
erklären. Selbst in EU-Mitgliedstaaten, die über hoch entwickelte Gesundheitsdienste
verfügen, gibt es beträchtliche Unterschiede bei der Organspende und –transplantation, und
einige Organisationsmodelle scheinen leistungsfähiger zu sein als andere.
Eine der möglichen Folgen der Organknappheit besteht im illegalen Handel mit menschlichen
Organen durch kriminelle Gruppen, die Organe in Entwicklungsländern ausfindig machen
und entnehmen, um sie dann an Empfänger in der Europäischen Union zu vermitteln.
Die vorliegende Mitteilung der Kommission über Organspende und -transplantation soll diese
Problematik auf der Rechtsgrundlage des Artikels 152 Absatz 4 Buchstabe a EG-Vertrag
aufgreifen, dem zufolge das Europäische Parlament und der Rat harmonisierte
Gesundheitsschutzmaßnahmen auf der Grundlage des Mitentscheidungsverfahrens gemäß
Artikel 251 EG-Vertrag treffen können, um hohe Qualitäts- und Sicherheitsstandards für
Organe menschlichen Ursprungs festzulegen. In der Mitteilung werden die Maßnahmen
dargestellt, welche die Kommission plant, um auf die hauptsächlichen politischen
Herausforderungen in Bezug auf Organspende und -transplantation zu reagieren:
Sicherstellung der Qualität und Sicherheit von Organen, Erhöhung der Spendenbereitschaft
und Bekämpfung des illegalen Organhandels.
Drucksache 16/7192 – 10 – Deutscher Bundestag – 16. Wahlperiode
2. ORGANSPENDE UND -TRANSPLANTATION: DIE AKTUELLE PROBLEMATIK
2.1. Transplantationsrisiken
Der therapeutische Einsatz von Organen bringt das Risiko einer Krankheitsübertragung auf
den Empfänger mit sich. In der wissenschaftlichen Literatur wurde die Übertragung von HIV,
Hepatitis B und C, Bakterien, Pilzen und Parasiten durch die Transplantation beschrieben,
ebenso wie die Übertragung verschiedener Krebsarten.
Die Übertragung einer Krankheit durch das Organ eines verstorbenen Spenders kann nicht nur
zum Verlust des Transplantats, sondern auch zum Tod des Empfängers führen, dessen
Immunreaktion ja unterdrückt wird. Trotz des Mangels an Organen verstorbener Spender
muss jedes Organ gründlich geprüft werden.
Jedes Jahr wird eine Reihe von Organen zwischen den EU-Mitgliedstaaten ausgetauscht. Die
Zahl der ausgetauschten Organe macht nur einen kleinen Anteil der gesamten in der EU
transplantierten Organe aus, mit Ausnahme der unter internationale Vereinbarungen
(Eurotransplant) fallenden Bereiche, in denen der Organaustausch bis zu 20 % der gesamten
Organtransplantationen ausmacht. Darüber hinaus lassen sich jedes Jahr eine Reihe von EU-
Bürgern in einem anderen Mitgliedstaat als ihrem Heimatland ein Organ transplantieren. Die
Zahl der Patienten, die versuchen, in einem anderen Land mit größerer Spendenbereitschaft
eine Organspende zu erhalten, ist offenbar im Steigen begriffen. Allerdings gelten in den
einzelnen Mitgliedstaaten unterschiedliche Qualitäts- und Sicherheitsanforderungen1. Die
Sicherstellung eines hohen Gesundheitsschutzniveaus für alle Patienten in ganz Europa stellt
daher eine Priorität dar.
2.2. Organmangel
Der gravierende Mangel an Organspendern ist auch weiterhin das Hauptproblem, vor dem die
EU-Mitgliedstaaten bei der Organtransplantation stehen.
In Europa sterben täglich beinahe zehn Patienten, die auf ein Organ warten. In allen EU-
Mitgliedstaaten werden die Wartelisten immer länger. Selbst in Fällen, in denen die Zahl der
Spender stetig angestiegen ist, erweist es sich als sehr schwierig, die Zahl der Patienten auf
den Wartelisten und die Wartezeiten zu verringern. Die Nachfrage nach Transplantationen
steigt schneller als die Spendenbereitschaft. Dennoch wird die steigende Zahl der Spender
dazu beitragen, die Kluft zwischen Angebot und Nachfrage zu verringern, auch wenn sich die
absoluten Zahlen auf den Wartelisten nicht senken lassen.
Für den Mangel an Spendern gibt es verschiedene Gründe2. Auch sind die Mitgliedstaaten bei
ihren Bemühungen zur Erhöhung der Spendenbereitschaft unterschiedlich erfolgreich. Die
Spenderraten variieren erheblich von einem europäischen Land zum anderen: die Rate der
verstorbenen Spender reicht von 0,8 bis 35,1 Spendern je Million Einwohner. Diese
Unterschiede sind nicht leicht zu erklären. Sie beruhen wahrscheinlich auf einer komplexen
Kombination kultureller, historischer und sozialer Faktoren, zusammen mit Aspekten des
Gesundheitswesens und der Organisation des Spendenwesens im jeweiligen Land.
1 http://ec.europa.eu/health/ph_threats/human_substance/documents/organ_survey.pdf.
2 Nähere Einzelheiten sind der Folgenabschätzung im Anhang zu dieser Mitteilung zu entnehmen.
Deutscher Bundestag – 16. Wahlperiode – 11 – Drucksache 16/7192
2.3. Illegaler Organhandel
Wie bereits erwähnt, ist das Angebot an Organen sehr begrenzt.
Zwar hat die strafrechtliche Verfolgung bisher keine Nachweise erbracht, doch es ist möglich,
dass international agierende kriminelle Organisationen die lukrativen Möglichkeiten erkannt
haben, die sich aus der Lücke zwischen Angebot und Nachfrage ergeben, und mehr Druck auf
Menschen ausüben, die in extremer Armut leben, damit diese ihre Organe verkaufen.
Das Problem des Organhandels ist nicht neu auf der Welt. In den 80er Jahren wurden
Fachleute auf ein Phänomen aufmerksam, das als „Transplantationstourismus“ bekannt
wurde. Dabei reisten wohlhabende Asiaten nach Indien und in andere Teile Südostasiens, um
Organe von in Armut lebenden Spendern zu erhalten. Seither haben sich andere
Möglichkeiten eröffnet.
Zwar bewegt sich der Organhandel in Europa nach aktuellen Schätzungen auf relativ
bescheidenem Niveau, dennoch gibt die Problematik Anlass zu ernster politischer und
ethischer Besorgnis.
3. DER MEHRWERT DER EU-MASSNAHMEN
In den letzten Jahren hat die Kommission erhebliche Anstrengungen unternommen, um die
Organtransplantation im Rahmen verschiedener Gemeinschaftsprogramme zu unterstützen. Es
wurde eine große Zahl von Projekten gefördert3, deren Ergebnisse beträchtliche Mengen an
Informationen und Erkenntnissen geliefert haben, welche für die Durchführung von EU-
Maßnahmen in diesem Bereich von Nutzen sein können. Es wird nun Zeit, diese Erkenntnisse
umzusetzen.
Im Juni 2006 leitete die Kommission eine öffentliche Anhörung zum Thema Organspende
und -transplantation ein. Anhand der Ergebnisse dieser Anhörung schlägt die Kommission
nun vor, weitere Initiativen auf Gemeinschaftsebene zu treffen, die zur Bewältigung der vor
uns liegenden Herausforderungen einen Mehrwert erbringen.
Im Mittelpunkt der Gemeinschaftsmaßnahmen in diesem Bereich steht die Gewährleistung
von Qualität und Sicherheit menschlicher Organe, da dieser Aspekt im Vertrag zur Gründung
der Europäischen Gemeinschaft Vorrang erhalten hat4. Eine von der italienischen Regierung
während ihres EU-Ratsvorsitzes 2003 veranstaltete Expertenkonferenz nannte den
Organmangel und den Organhandel als Hauptprioritäten in diesem Bereich und unterstrich,
dass Qualitäts- und Sicherheitsaspekte im Rahmen von Organangebot und -nachfrage
umfassend zu berücksichtigen sind. Um die genannten Herausforderungen angemessen
bewältigen zu können, bedarf es eines integrierten Vorgehens mit drei Aktionen.
3 Eine Beschreibung der Projekte ist der Folgenabschätzung im Anhang zu dieser Mitteilung zu
entnehmen.
4 Seit 1999 ermöglicht Artikel 152 EGV es dem Europäischen Parlament und dem Rat,
Gesundheitsschutzmaßnahmen anzunehmen, die hohe Qualitäts- und Sicherheitsstandards für Organe
und Substanzen menschlichen Ursprungs, Blut und Blutderivate festlegen. Die Gemeinschaft hat bereits
Richtlinien des Parlaments und des Rates für Blut sowie für Gewebe und Zellen festgelegt.
Drucksache 16/7192 – 12 – Deutscher Bundestag – 16. Wahlperiode
3.1. Qualitäts- und Sicherheitsrahmen für Organspende und -transplantation
In jeder Phase des Transplantationsverfahrens lässt sich eine Reihe von Maßnahmen
durchführen, um die Qualität und die Sicherheit der Organe zu verbessern.
Ein wesentlicher Bestandteil einer soliden Organtransplantation besteht darin, die potenziellen
Spender vor der Transplantation zu untersuchen. Diese Untersuchung muss genügend
Informationen liefern, damit das Transplantationsteam eine angemessene Nutzen-Risiko-
Analyse erstellen kann. Die Risiken und Merkmale des Organs sind zu ermitteln und zu
dokumentieren, damit das Organ einem geeigneten Empfänger zugeteilt werden kann.
Als wesentliche Schritte in Richtung auf Qualität und Sicherheit haben sich Aufzeichnungen
über Spender und Qualitätssysteme erwiesen. Es müssen Standardverfahren für die Entnahme
und Vorschriften für die Aufbewahrung und den Transport von Organen vorhanden sein.
Sicherzustellen ist ein geeigneter Transport der Organe, der Zeiten ohne Blutversorgung
minimiert und Organschädigungen vermeidet. Bei gleichzeitiger Wahrung der medizinischen
Vertraulichkeit muss der Organbehälter klar beschriftet werden und die erforderliche
Dokumentation enthalten.
Das Transplantationssystem muss sicherstellen, dass die Spur vom Spender zum Empfänger
verfolgt werden kann. Das System muss im Falle einer unvorhergesehenen Komplikation
warnen können. Zudem muss ein System vorhanden sein, mit dem sich ernste oder
unvorhersehbare unerwünschte Zwischenfälle erkennen und untersuchen lassen.
Ein Organspender ist oft auch ein Gewebespender. Die Qualitäts- und
Sicherheitsanforderungen für Organe sollten mit dem bestehenden Gemeinschaftssystem für
Gewebe und Zellen5 verbunden werden und dieses ergänzen. Eine unerwünschte Reaktion
beim Empfänger einer Organspende sollte zurückverfolgt und bei Bedarf über das
Gewebevigilanzsystem gemeldet werden.
Es wurde bereits betont, welche Schlüsselrolle die einzelstaatlichen zuständigen Behörden bei
der Gewährleistung von Qualität und Sicherheit dieses Verfahrens spielen, und ebenso, wie
wichtig es ist, Systeme für die Zulassung von Einrichtungen sowie Programme für
Organspende und -entnahme auf der Grundlage gemeinsamer Qualitäts- und
Sicherheitskriterien zu schaffen. Dieses System sollte eine vollständige Liste aller
zugelassenen Zentren in ganz Europa liefern, auf die sowohl die Öffentlichkeit als auch
Angehörige der Gesundheitsberufe Zugriff haben.
Verbindliche Sicherheits- und Qualitätskriterien sollten nicht zur Senkung der Zahl der
Spender führen. Es ist wichtig, über das Krankheitsübertragungsrisiko, das mit jedem Fall
einhergeht, Klarheit zu gewinnen. Zwar ist eine Risikodefinition anhand des Spenderprofils
für eine rationale Entscheidungsfindung entscheidend, doch jede Entscheidung hängt auch
von den Merkmalen des Empfängers ab. In jedem Einzelfall sind Nutzen und Risiken
gegeneinander abzuwägen: das mit dem Organ verbundene Risiko gegen die Folgen, wenn
keine Transplantation erfolgt.
5 Richtlinie 2004/23/EG des Europäischen Parlaments und des Rates vom 31. März 2004 zur Festlegung
von Qualitäts- und Sicherheitsstandards für die Spende, Beschaffung, Testung, Verarbeitung,
Konservierung, Lagerung und Verteilung von menschlichen Geweben und Zellen (ABl. L 102 vom
7.4.2004, S. 48).
Deutscher Bundestag – 16. Wahlperiode – 13 – Drucksache 16/7192
3.2. Zusammenarbeit zwischen den Mitgliedstaaten
Organmangel ist ein gemeinsames Problem aller Länder Europas, und der Knowhow-Transfer
innerhalb der EU hat sich in einigen Ländern zur Erhöhung der Spenderraten bereits als
sinnvoll erwiesen.
3.2.1. Organangebot
Einige Mitgliedstaaten haben verschiedene Initiativen eingeführt, in deren Mittelpunkt
Organisation und Praxis von Spendesystemen stehen, mit denen nachweislich das
Organangebot erhöht werden konnte.
Ein wichtiger Faktor zur Ermittlung von Personen, die zur Spende nach ihrem Tode bereit
sind, sobald alle obligatorischen Zustimmungsanforderungen der jeweiligen Mitgliedstaaten
erfüllt sind, besteht offenbar darin, ein leistungsfähiges System einzurichten, das verstorbene
potenzielle Spender ermittelt und zu tatsächlichen Spendern macht. Es hat sich gezeigt, dass
viele Spender verloren gehen, weil keine Überprüfung oder keine Meldung stattfindet oder
weil es versäumt wird, den Angehörigen eine Organspende nahezulegen.
In manchen Mitgliedstaaten hat die Fortbildung und Beschäftigung von für die Ermittlung
potenzieller verstorbener Organspender und die Organisation des Organspendeverfahrens
zuständigen Beschäftigten des Gesundheitswesens die Leistungsfähigkeit der
Organbeschaffung erhöht und dazu geführt, dass die Transplantationssysteme besser
funktionieren.
Um den Spenderkreis zu erweitern, wäre es wichtig, die Förderung der altruistischen
Lebendspende zu erwägen, und zwar auf der Grundlage angemessener
Sicherheitsvorkehrungen zum Schutz der lebenden Spender und zur Verhinderung illegalen
Organhandels. Lebendspenden liegen in Europa bei 17 % der Nierentransplantationen und bei
5 % der Lebertransplantationen vor. Obgleich lebende Spender immer schon von
entscheidender Bedeutung für die Transplantation waren, ist der Einsatz von Lebendspendern
in den letzten Jahren drastisch gestiegen. Der Anstieg der Lebendspenden ist auf mehrere
Faktoren zurückzuführen, unter anderem auf den Druck durch den Mangel an Spenderorganen
von Verstorbenen, auf Fortschritte in der Chirurgie und überzeugende Nachweise günstiger
Transplantationsergebnisse und geringer Spenderrisiken. Die Zahl der freiwilligen
Lebendspendern ist innerhalb Europas ebenfalls höchst unterschiedlich.
Unter bestimmten Umständen wäre es auch möglich, andere potenzielle Spender (einen
„erweiterten Spenderkreis“) in Erwägung zu ziehen, die aufgrund einer positiven Serologie,
angeborener oder erblicher Gesundheitsstörungen, familiärer Belastung oder anderer
Merkmale wie Spenderalter, Bluthochdruck oder Diabetes keine idealen Spender wären.
3.2.2. Das Bewusstsein der Öffentlichkeit
Das Bewusstsein der Öffentlichkeit und die öffentliche Meinung spielen ebenfalls eine
wichtige Rolle bei der Verstärkung der Spendenbereitschaft.
Organspende und -transplantation sind therapeutische Maßnahmen, an deren Entwicklung die
gesamte Gesellschaft mitwirken muss. In diesem Bereich gibt es viele komplexe und heikle
Fragen der Ethik, und es ist deutlich geworden, dass mehrere dieser Aspekte in den
Drucksache 16/7192 – 14 – Deutscher Bundestag – 16. Wahlperiode
verschiedenen Ländern je nach den kulturellen Wertvorstellungen unterschiedlich behandelt
werden.
Im Jahre 2006 erklärten sich 56 % der Europäer bereit6, ihre Organe nach dem Tode einem
Organspendedienst zur Verfügung zu stellen. Die Antworten auf die Befragung waren je nach
Land höchst unterschiedlich.
Die Quoten der Ablehnungen einer Organspende Verstorbener durch die Angehörigen
betragen in Europa zwischen 6 % und 42 %. Auch diese Unterschiede sind nicht leicht zu
verstehen. Sie ließen sich erklären durch die große Vielfalt der Verfahren zur Einholung der
Zustimmung des Spenders – bei lebenden und verstorbenen Spendern – unterschiedliche
organisatorische Praxis sowie andere wichtige kulturelle, wirtschaftliche oder soziale
Faktoren, die einen Einfluss darauf haben, wie die Gesellschaft den Nutzen der Organspende
wahrnimmt.
Die kostengünstigste Möglichkeit, die Spendenbereitschaft der Öffentlichkeit zu erhöhen,
scheint darin zu bestehen, die Beschäftigten im Gesundheitswesen und die Medien besser
über Transplantationsfragen zu informieren. Da sowohl positive als auch negative Botschaften
die Spendenbereitschaft beeinflussen können, bedarf es einer professionellen Einstellung
gegenüber der Spende und der Unterstützung durch Kommunikationsexperten.
Fortgesetzte Aufklärung sollte ein wesentliches Element jeder Kommunikationsstrategie sein.
Die Menschen sollten dazu ermutigt werden, über die Organspende zu sprechen und ihren
Angehörigen ihre Wünsche mitzuteilen. Nur 41 % der europäischen Bürger haben mit ihren
Angehörigen über eine mögliche Organspende gesprochen6. Es besteht ein wichtiger
Zusammenhang zwischen der Spendenbereitschaft und der Tatsache, darüber mit seinen
Familienangehörigen gesprochen zu haben.
Die Schaffung eines europäischen Spenderausweises, dem zu entnehmen ist, ob der Inhaber
zur Organspende bereit ist oder nicht, wird dazu beitragen, die Öffentlichkeit für die
Problematik zu sensibilisieren. 81 % der europäischen Bürger sprechen sich für die
Verwendung eines Spenderausweises aus, damit leichter ermittelt werden kann, wer bereit ist,
nach dem Tode Organe zu spenden. Dennoch haben bisher lediglich 12 % der Europäer einen
Spenderausweis.
3.2.3. Organisatorische Aspekte
Ein Vergleich der einzelnen Länder zeigt, dass die Spenderraten nicht immer mit den
Prozentsätzen derjenigen übereinstimmen, die zuvor in diesen Ländern ihre
Spendenbereitschaft erklärt haben. Dies zeigt deutlich, wie wichtig ein leistungsfähiges
Transplantationssystem ist, um sicherzustellen, dass die Organe der spendenbereiten Personen
auch zur Verfügung gestellt werden.
Voraussetzung für jegliche Maßnahme in diesem Bereich ist die Schaffung geeigneter
Transplantationssysteme auf einzelstaatlicher Ebene. Ein solches System braucht einen
angemessenen Rechtsrahmen, einen guten fachlichen Ansatz und organisatorische
Unterstützung. Die Rolle der zuständigen Behörden ist entscheidend bei der Organisation. Die
6 Eurobarometer-Umfrage 2006.
Deutscher Bundestag – 16. Wahlperiode – 15 – Drucksache 16/7192
Behörden müssen dafür sorgen, dass die grundlegenden Standards eingehalten werden, und
sie müssen die Spende- und Transplantationsaktivitäten organisieren.
Die verschiedenen Organisationssysteme in Europa sind das Ergebnis ihrer Ursprünge und
ihrer Geschichte. Selbst in den EU-Ländern, die über hoch entwickelte Gesundheitsdienste
verfügen, gibt es beträchtliche Unterschiede bei der Organspende und –transplantation, und
einige Organisationsmodelle scheinen leistungsfähiger zu sein als andere.
Organtransplantationen unterliegen starkem Zeitdruck. Das Verfahren von der Beschaffung
bis zur Transplantation sollte in einigen wenigen Stunden abgeschlossen sein (um das Organ
lebensfähig zu erhalten). Zudem muss der Spender zum Empfänger passen, damit ein Organ
transplantiert werden kann. Deshalb ist die Organisationsstruktur ein Schlüsselelement der
Organspende-/Organtransplantationssysteme.
Als Teil dieser Organisation ist ein wirksames Zuteilungssystem von wesentlicher Bedeutung.
Dieses System muss die kurze Zeit berücksichtigen, in der die Organe lebensfähig erhalten
werden können, und die Notwendigkeit, sicherzustellen, dass das Organ nach vorher
definierten Kriterien dem geeignetsten Empfänger zugeteilt wird.
Die neuen Mitgliedstaaten stehen vor größeren gesundheitlichen Problemen als die übrige
Union, haben jedoch weniger wirtschaftliche Ressourcen zu deren Bewältigung. Ihre
Gesundheitssysteme stehen deshalb unter besonderem Druck, insbesondere, was das
Verfahren von der Organspende bis zur Transplantation angeht, dessen Komplexität
besondere Schwierigkeiten verursachen kann. Dies führt zu enormen Unterschieden zwischen
den einzelnen Mitgliedstaaten, was den Zugang zu Transplantationen und die Länge der
Wartelisten betrifft. Diese Systeme können besonders von einer Zusammenarbeit auf EU-
Ebene profitieren.
Es ist allgemein anerkannt, dass sich Spender und Empfänger umso besser aufeinander
abstimmen lassen, je größer der Spenderkreis ist. Dringlichkeitspatienten und
Problemempfänger (Kinder, hoch sensible Patienten usw.) können innerhalb einer kleinen
Organisation nicht wirksam behandelt werden; dies ist besonders in kleinen Mitgliedstaaten
problematisch. Gleichzeitig hat auf der Spenderseite die Beteiligung lokaler Akteure
(Krankenhaustransplantationsteams und Transplantationskoordinatoren) am
Entscheidungsprozess dazu beigetragen, die betreffenden Berufsgruppen zu motivieren, und
bessere Ergebnisse hervorgebracht.
Ein flexibles System, das ein dezentralisiertes Netz aus lokalen Organisationen, die sich
hauptsächlich auf die Organbeschaffung und die Förderung der Organspende konzentrieren,
mit großen Organisationen verbindet, die sich auf die Förderung des Organaustauschs und der
Zusammenarbeit konzentrieren, scheint organisatorisch am effektivsten zu sein.
Das Übereinkommen Nr. 26 des Europarats über den Austausch therapeutischer Substanzen
menschlichen Ursprungs von 1958 war der Ausgangspunkt für grenzübergreifende
Tätigkeiten in diesem Bereich. Die Arbeit des Europarats, von Eurotransplant,
Scandiatransplant, des Europäischen Transplantationsnetzes oder die regelmäßigen Sitzungen
der Europäischen Organisationen für Organaustausch sind gute Beispiele für die notwendige
europäische Zusammenarbeit7.
7 Nähere Einzelheiten sind der Folgenabschätzung im Anhang zu dieser Mitteilung zu entnehmen.
Drucksache 16/7192 – 16 – Deutscher Bundestag – 16. Wahlperiode
3.3. Bekämpfung des Organhandels
Gemäß Artikel 3 der EU-Charta der Grundrechte hat jeder das Recht auf körperliche
Unversehrtheit. Außerdem verbietet die Charta es, den menschlichen Körper und Teile davon
zur Erzielung von Gewinnen zu nutzen. Ferner enthält sie das Verbot des Menschenhandels.
Als Teil des allgemeinen Phänomens des Menschenhandels stellt der Handel zum Zwecke der
Organentnahme einen gravierenden Verstoß gegen die Freiheit und die körperliche
Unversehrtheit seiner Opfer dar.
Der Europarat8 und die Weltgesundheitsorganisation9 haben bereits mehrfach zu Maßnahmen
aufgerufen, um den Organhandel zu bekämpfen. Das Verbot des Handels mit menschlichen
Organen und Geweben ist bereits durch internationale Rechtsinstrumente in Kraft gesetzt
worden, wie das Übereinkommen von Oviedo über die Menschenrechte und Biomedizin
sowie sein Zusatzprotokoll über die Transplantation von Organen und Geweben menschlichen
Ursprungs. Außerdem verpflichtet das Protokoll über die Verhütung, Bekämpfung und
Bestrafung des Menschenhandels, welches das UN-Übereinkommen zur Bekämpfung des
internationalen organisierten Verbrechens ergänzt, die Unterzeichnerstaaten, diese Form des
Menschenhandels als Verbrechen zu behandeln und verhältnismäßige und abschreckende
Strafen zu erlassen.
Die Kommission bezieht sich ständig auf diese wichtigen internationalen Instrumente und
wird alle Entwicklungen im Bereich des illegalen Organhandels sowohl in der EU als auch
weltweit aufmerksam verfolgen
4. SCHLUSSFOLGERUNGEN UND FOLGEMASSNAHMEN
Die Arbeit im Rahmen der verschiedenen Gemeinschaftsprogramme wird in den kommenden
Jahren fortgesetzt. Wichtig ist, dass die Ergebnisse dieser Projekte auf politischer Ebene
weiterverfolgt und gutgeheißen werden; die Ergebnisse müssen allen Beteiligten zur
Verfügung gestellt werden.
Die Hauptaktionsschwerpunkte hinsichtlich Organspende und –transplantation sind folgende:
� Verbesserung von Qualität und Sicherheit
Die Kommission wird unter Berücksichtigung des bisherigen Dialogs mit den Mitgliedstaaten
den genauen, ausgewogenen Umfang des Rechtsrahmens für Qualität und Sicherheit
menschlicher Organe festlegen. Dieser Rahmen muss durch die Zusammenarbeit der
Mitgliedstaaten gestützt werden; dabei sind ausreichende Informationen zusammenzustellen,
anhand deren festgelegt werden kann, welche Risiken beim Einsatz erweiterter Spenderkreise
und durch die Förderung guter medizinischer Praxis und die Evaluierung der
Posttransplantationsergebnisse („Organvigilanz“) vertretbar sind.
8 Empfehlung Rec (2004) 7 des Ministerkomitees.
9 Entschließung WHA 42.5 zur Verurteilung des Kaufs und Verkaufs von Organen menschlichen
Ursprungs.
Deutscher Bundestag – 16. Wahlperiode – 17 – Drucksache 16/7192
� Erhöhung der Organverfügbarkeit
Die Kommission wird die Zusammenarbeit zwischen den Mitgliedstaaten fördern, um
Erfahrungen und vorbildliche Verfahren auszutauschen, damit leistungsfähige Systeme für die
Organspenderermittlung eingerichtet werden können.
Ferner bedarf es der Zusammenarbeit, um die Schulung von im Gesundheitswesen
Beschäftigten anhand modellhafter Erfahrungen zu fördern, die Förderung von
Lebendspenden zu erwägen und den Einsatz eines erweiterten Spenderkreises (der aus
medizinischer Sicht nur für bestimmte Empfänger unter bestimmten Umständen in Frage
kommt) unter Berücksichtigung von Qualitäts- und Sicherheitsaspekten zu bewerten.
Zudem wird es von Bedeutung sein, gemeinsame Bemühungen zu unternehmen und
Erfahrungen auszutauschen, um das Bewusstsein der Öffentlichkeit zu schärfen. In diesem
Zusammenhang ist die Schaffung eines europäischen Organspenderausweises oder dessen
Einbeziehung in die bestehende Europäische Krankenversicherungskarte zu erwägen.
� Erhöhung der Leistungsfähigkeit und Zugänglichkeit der Transplantationssysteme
Wie auch andere Fragen des Zugangs zur gesundheitlichen Versorgung ist diese Frage im
Zusammenhang mit anderen einschlägigen Initiativen auf Gemeinschaftsebene zu betrachten.
Die Initiativen werden sich darauf konzentrieren, die leistungsfähigsten Systeme zu ermitteln,
Erfahrungen auszutauschen und vorbildliche Verfahren unter Berücksichtigung lokaler
Gegebenheiten zu fördern. Diejenigen Mitgliedstaaten, deren Transplantationssysteme noch
nicht ausreichend entwickelt sind, können in ihren Bemühungen zur Verbesserung der
Patientenversorgung unterstützt und angeleitet werden.
Weitere Aktionen werden sich darauf richten, den Bedarf für den Organaustausch zwischen
einzelstaatlichen Behörden auf EU-Ebene zu ermitteln. Leitlinien für Verfahren zum Angebot
überzähliger Organe an andere Länder können unter besonderer Berücksichtigung des
Organaustauschs für Dringlichkeits- und Problempatienten bewertet werden.
Die zunehmende Mobilität der EU-Bürger erfordert es, die Hauptprobleme bei der
Patientenmobilität zu ermitteln. Auch wird es wichtig sein, EU-weite Vereinbarungen über
alle Fragen zu treffen, die die Transplantationsmedizin für Nicht-EU-Bürger betreffen.
Die Kommission schlägt folgende Maßnahmen vor:
� Aktionsplan zur verstärkten Zusammenarbeit zwischen den Mitgliedstaaten
Bei der Analyse der Organtransplantationslage in der EU wurden große Unterschiede bei der
Rate der verstorbenen und lebenden Spender innerhalb der EU und ebenso große
Unterschiede in der Transplantationstätigkeit festgestellt. Diese Unterschiede sind nicht leicht
zu erklären, und es ist deutlich geworden, dass einige Modelle leistungsfähiger sind als
andere. Der Know-how-Transfer unter den EU-Mitgliedstaaten und die Zusammenarbeit
zwischen den Ländern sind noch ausbaufähig, um die Zahl der Organspenden zu maximieren
und gleichen Zugang für alle zur Transplantation zu schaffen. Die Gemeinschaft wird das
beste der besten Modelle ermitteln und unter Berücksichtigung der kulturellen und
organisatorischen Vielfalt dessen EU-weite Anwendung fördern.
Drucksache 16/7192 – 18 – Deutscher Bundestag – 16. Wahlperiode
Schon in der vom Rat der Gesundheitsminister 1991 angenommenen Entschließung10 über
richtungweisende Entscheidungen in der Gesundheitspolitik hat der Rat die Prüfung eines
möglichen Beitrags der Gemeinschaft zur Verfügbarkeit von Transplantationsorganen als
eines der Themen genannt, das gemeinsamer Erwägung, regelmäßiger gemeinsamer
Erörterung und/oder gemeinsamer Anstrengungen bedarf, um die Mitgliedstaaten bei der
Gestaltung ihrer Gesundheitspolitik zu unterstützen. Die wichtigsten europäischen
Organaustauschorganisationen haben ebenfalls empfohlen, die besten Initiativen zu ermitteln,
um den Erfahrungs- und Informationsaustausch zwischen den EU-Mitgliedstaaten zu fördern
und organisatorische Aspekte zu verbessern.
Ein Aktionsplan für engere Zusammenarbeit zwischen den Mitgliedstaaten, der speziell auf
diesen konkreten Bereich zugeschnitten ist, wird das nötige politische Instrumentarium
liefern, damit man sich schrittweise an die Entwicklung einer EU-Politik annähert. Dieser
Ansatz sollte auf der Ermittlung und Entwicklung gemeinsamer Ziele, für die
anerkanntermaßen ein gemeinschaftliches Vorgehen erforderlich ist, auf vereinbarten
quantitativen und qualitativen Indikatoren und Maßstäben, regelmäßiger Berichterstattung
sowie der Ermittlung und dem Austausch vorbildlicher Verfahren beruhen.
� EU-Rechtsinstrument über Qualität und Sicherheit von Organspende und
-transplantation
Die Gemeinschaft hat bereits Richtlinien des Europäischen Parlaments und des Rates über
Qualitäts- und Sicherheitsstandards für Blut11 sowie für Gewebe und Zellen12 erlassen. Eine
mögliche europäische Richtlinie zur Festsetzung von Qualitäts- und Sicherheitsstandards für
Organe könnte ähnliche Fragen behandeln; allerdings ist das Nutzen-Risiko-Verhältnis von
grundlegender Bedeutung für die Organtransplantation. Wegen des Organmangels und der
lebensbedrohlichen Indikationen für Organtransplantationen ist deren Nutzen hoch und es
sind mehr Risiken vertretbar als bei den meisten Behandlungen mit Blut, Geweben und
Zellen. In diesem Zusammenhang spielt der Arzt eine wichtige Rolle bei der Entscheidung, ob
ein Organ zur Transplantation angenommen wird. Der Vorschlag der Kommission wird
diesen Besonderheiten der Organspende und –transplantation Rechnung tragen.
Die Folgenabschätzung im Anhang zu dieser Mitteilung kommt zu dem Schluss, dass ein
angemessener und flexibler europäischer Rechtsrahmen auf der Grundlage weiterer
Zusammenarbeit mit den Mitgliedstaaten die geeignete Reaktion der Gemeinschaft auf das
Mandat gemäß Artikel 152 Absatz 4 Buchstabe a EGV darstellt.
Das künftige Rechtsinstrument, das auf einer eigenen Folgenabschätzung beruht, könnte
Grundsätze umfassen, die für die Schaffung eines grundlegenden Qualitäts- und
Sicherheitsrahmens erforderlich sind. Dazu gehören
– die Errichtung einer oder mehrerer einzelstaatlichen Aufsichtsbehörden zur
Umsetzung der Vorschriften der Richtlinie;
– gemeinsame Qualitäts- und Sicherheitsstandards für die Zulassung von
Einrichtungen und Programmen für Organspende und -beschaffung sowie für
angemessene Konservierung und Beförderung der Organe;
10 Entschließung des Rates und der Gesundheitsminister (ABl. C 304 vom 23.11.1991, S. 5).
11 ABl. L 33 vom 8.2.2003, S. 30.
12 ABl. L 102 vom 7.4.2004, S. 48.
Deutscher Bundestag – 16. Wahlperiode – 19 – Drucksache 16/7192
– die Sicherstellung der Rückverfolgbarkeit und die Meldung etwaiger schwerer
unerwünschter Zwischenfälle und Reaktionen;
– die Einrichtung von Inspektionsstrukturen und Kontrollmaßnahmen;
– die Sicherstellung einer vollständigen Merkmalbeschreibung des Organs, damit
das Transplantationsteam eine angemessene Risikobewertung vornehmen kann.
Drucksache 16/7192 – 20 – Deutscher Bundestag – 16. Wahlperiode
COUNCIL OF
THE EUROPEAN UNION
Brussels, 4 June 2007
9834/07
ADD 1
SAN 108
COVER NOTE
from: Secretary-General of the European Commission,
signed by Mr Jordi AYET PUIGARNAU, Director
date of receipt: 31 May 2007
to: Mr Javier SOLANA, Secretary-General/High Representative
Subject: Commission Staff Working Document
Accompanying document to the communication from the Commission
to the European Parliament and the Council
Organ donation and transplantation: Policy Actions at EU Level
Impact Assessment
Delegations will find attached Commission document SEC(2007) 704.
________________________
Encl.: SEC(2007) 704
Deutscher Bundestag – 16. Wahlperiode – 21 – Drucksache 16/7192
COMMISSION OF THE EUROPEAN COMMUNITIES
Brussels, 30.5.2007
SEC(2007) 704
COMMISSION STAFF WORKING DOCUMENT
Accompanying document to the
COMMUNICATION FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
ORGAN DONATION AND TRANSPLANTATION: POLICY ACTIONS AT EU
LEVEL
IMPACT ASSESSMENT
{COM(2007) 275 final}
{SEC(2007) 705}
Drucksache 16/7192 – 22 – Deutscher Bundestag – 16. Wahlperiode
Lead DG: SANCO
Other involved services: DG ENTR, DG RESEARCH, DG INFSO, DG RELEX, DG JLS,
LS and SG
Agenda planning or WP reference: CLWP 2007/2005/SANCO/032
Deutscher Bundestag – 16. Wahlperiode – 23 – Drucksache 16/7192
TABLE OF CONTENTS
1. Executive summary.................................................................................................... 24
2. Procedural issues and consultation of interested parties. ........................................... 25
3. Problem definition...................................................................................................... 30
3.1. Quality and safety ...................................................................................................... 31
3.2. Organ Shortage........................................................................................................... 41
3.3 Organisational systems…………………………………………………..…………. 55
3.4 The rational for EU action …………………………………………………………. 62
4. Objectives................................................................................................................... 65
5. Policy options............................................................................................................. 65
6. Analysis of impacts .................................................................................................... 68
6.1. Political impact........................................................................................................... 68
6.2. Economic impact........................................................................................................ 70
6.3. Assessing the impact on health and social welfare .................................................... 72
6.4. Environmental impact ................................................................................................ 74
7. Comparing the options ............................................................................................... 74
7.1. Summary of the contributions of the open consultation ............................................ 74
7.2. Comparison of the options ......................................................................................... 74
7.3. Conclusions ................................................................................................................ 80
8. Monitoring and evaluation ......................................................................................... 83
Annex ………………………………………………………………………………………..84
77
Drucksache 16/7192 – 24 – Deutscher Bundestag – 16. Wahlperiode
IMPACT ASSESSMENT1 ON A COMMISSION COMMUNICATION ON ORGAN
DONATION AND TRANSPLANTATION
1. EXECUTIVE SUMMARY
Organ transplantation is the therapeutic use of human organs involving the substitution of a
non-functional organ for another one coming from a donor. The use of human organs for
transplantation has steadily increased during the past decades. Organ transplantation is now
the most cost-effective treatment for end-stage renal failure, and for end-stage failure of
organs such liver, lung and heart, it is the only available treatment.
The use of organs in therapy poses a risk of transmission of diseases to the recipient.
Infectious or cancerous diseases could be transmitted. Every year, a number of organs are
exchanged between EU Member States. Cross border exchanges imply that the transplantation
process is carried out by hospitals or professionals falling under different jurisdictions.
In 2003, the Commission carried out a survey on legal requirements related to organ
transplantation in the EU. The survey showed discrepancies in quality and safety requirements
between Member States2.
On the other hand, the shortage of organs is a major factor affecting transplantation
programmes. Nearly 40 000 patients are now on waiting lists in western Europe. Mortality
rates while waiting for a heart, liver or lung transplant usually range from 15 to 30%. One of
the potential consequences of the scarcity of organs is the trafficking of human organs carried
out by organised criminal groups, tracking down and removing organs in developing countries
and handing them on to recipients within the European Union.
This Commission Communication on Organ donation and transplantation intends to respond
to the main policy challenges related to the mandate of Article 152.4 a) of the Treaty, which
enables the European Parliament and Council to adopt health measures setting high standards
of quality and safety of blood, blood components, organs and substances of human origin
The Community has already adopted Directives of the Parliament and the Council on quality
and safety standards for blood in 2003 and for Tissues and Cells in 2004. However, it was
already recognized during the discussions of the Tissues and cells Directive that organs need a
different approach. In this particular area the main priority is to reduce the organ shortage and
the quality and safety aspects have to be considered at the same time that the shortage of
organs for the patients in need.
Three levels of possible intervention have been considered. Level one “further work under
existing Community programmes.” would mean continuing the current level of activity. A
second level would consist of implementing an active system of coordination between
Member States and stakeholders in order to achieve common objectives, and a third level,
building on the previous one, that would add EU legal instruments.
1 On the basis of SEC (2005) 791 of 15 June 2005 (Impact Assessment Guidelines)
2 http://ec.europa.eu/health/ph_threats/human_substance/documents/organ_survey.pdf
Deutscher Bundestag – 16. Wahlperiode – 25 – Drucksache 16/7192
As a conclusion the Commission is proposing a combination of actions oriented to respond to
the above mentioned problems. Strengthen the cooperation between Member states will
provide the necessary policy mix to achieve a gradual approach to the development of an EU
policy. This approach will be based, in the first stage at least, on the identification and
development of common objectives for which it is agreed that a Community response is
necessary, on agreed quantitative and qualitative indicators and benchmarks, regular reporting
and identification of best practices. It will be necessary to determine common EU guidelines
for national policy, and formulate the objectives for the short, medium and long term, where
necessary in combination with national plans monitoring and comparing national systems,
based on a determined set of indicators. It will describe the instruments and methods needed.
A legal framework introducing the basic principles and the technical requirements on
donation, procurement, testing preservation, transport and distribution, for human organs will
complement the approach taken under the strength cooperation method. The future legal
instrument should be limited to those minimum requirements needed to establish a basic
quality and safety framework.
To measure the possible impacts of the different options the Commission has used several
sources.
– Experience with existing EU legislation on blood and human tissues and cells;
– EU survey on organ donation and transplantation
– Eurobarometer survey on organ donation and transplantation
– Consultation with Member States experts
– Extensive consultation with all stakeholders;
– Relevant publications of other international organisation: Council of Europe, WHO
– Published literature on scientific, economic, regulatory and ethical aspects of organ
transplantation
– Conclusions/contributions from the projects funded by Community programmes
This document is to be read together with the draft Communication on Organ donation and
transplantation
2. PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES.
2.1. Organisation and timing
(1) In 2003, the Commission carried out a survey on legal requirements related to organ
transplantation in the EU. The survey showed discrepancies in quality and safety
requirements within Member States. Results can be found at:
http://europa.eu.int/comm/health/ph_threats/human_substance/documents/organ_surve
y.pdf
Drucksache 16/7192 – 26 – Deutscher Bundestag – 16. Wahlperiode
(2) The Greek Presidency of the EU presented in February 2003 an initiative (3), with a
view to adopting a Council framework decision concerning the prevention and control
of trafficking in human organs and tissues, under the legal basis of Articles 29, 31(e),
and 34(2)(b) of the EU Treaty (third pillar). The discussions on the initiative were
suspended on Coreper on 22 May, pending further detailed information on the
situation, especially based in concrete cases. Europol has been asked to issue a report
on the situation of Organ trafficking in the EU
(3) The Venice Conference on Safety and Quality in Organ Donation and Transplantation
in the European Union was held on 17-18 September 2003. The Conclusions of the
expert conference organised by the Italian government during its Presidency of the EU
Council, listed the shortage of organs and organ trafficking as the main priorities in
this area and underlined that the quality and safety aspects have to be considered fully
within the framework of supply and demand for organs.
(4) With the occasion of the adoption of the Tissues and cells Directive on 31 March
2004, the Commission made the following declaration to be entered in the minutes:
"The important differences between organ transplantation and the use of other human
substances such as blood, tissues and cells mean that a specific approach for organs in
order to ensure safety and quality is necessary. Such an approach in the current
situation characterised by shortage of organs has to balance two factors: the need for
organs' transplantation which is usually a matter of life and death with the need to
ensure high standards of quality and safety. The Commission believes that before
considering any proposal it is necessary to conduct a thorough scientific evaluation of
the situation regarding organ transplantation. The Commission will present a report on
the conclusions of the analysis it undertakes as soon as possible."
(5) During March and April 2005, DG SANCO has identified all projects related with
organ transplantation. During these two months the relevant DGs were contacted all
projects funded with EC money and their respective project officers were identified.
Meetings with the different DGs and project officers were held on May, September
and October. As a result the Commission (DG INFSO, RTD and SANCO) organised a
Workshop in December 2005 on organ transplantation with the objective of promoting
EU cooperation on organ donation and transplantation on the basis of the existing
projects. Project coordinators, member states experts and transplantation organisations
participated. One of the main conclusions of the workshop was the need for these
projects to become operational.
(6) On April 2005 the Commission announced the conduction of an evaluation of the
situation regarding organ transplantation to the Inter service group on health (ISGH).
An ad-hoc working group on organ transplantation was created within the group. The
work linked to the present impact assessment report was supported by this Inter-
service Steering Group (ISSG) of the European Commission set up in September
2005. The Group was led by the Directorate General for Health and Consumer
Protection (DG SANCO). The following DGs were involved in the exercise, DG RTD,
DG ENTR, DG INFSO, DG RELEX, DG AIDCO, DG JLS, SJ and Sec-Gen.
(7) A scoping paper was drafted in August 2005 and has been circulated with the draft
proposals for consultation during the autumn 2005. On August the scoping paper on
organ donation and transplantation was finalised and approved by the Director general,
it also incorporated a time table with the following steps.
Deutscher Bundestag – 16. Wahlperiode – 27 – Drucksache 16/7192
(8) On 15 November 2005 the Commission hosted a meeting with key experts on organ
transplantation. The objective of the meeting was to discuss the future impact
assessment of future community initiatives on organ transplantation. Experts from
Eurotransplant; Scandiatransplant, CNT, ONT, Agence de la Biomedicine; Hungaro
transplant and UK transplant participated.
(9) In order to give stakeholders and Member States an occasion to put forward their
positions related to Organ donation and transplantation DG SANCO launched an open
consultation in the public health web site from June to September 2006. The draft
proposal of the consultation document were sent to relevant DGs in an informal inter-
service consultation and presented to the ISGH. A number of replies have been
received so far and comments have been taken into account (results of the consultation
below).
(10) A preliminary draft of this Impact assessment has been examined by the Impact
assessment board, set up in November 2006 by the President of the Commission, with
the mandate to examine and advice on the quality of impact assessment (IA) reports.
The board has delivered a favourable opinion on 2 March 2007 with three main
recommendations. This has led to a number of modifications in the text oriented to
clarify the objectives of the policy proposal and the relations between the different
objectives. The justification for a EU action has also been strengthened and clarified in
the final version following the recommendations of the board. Some modifications in
the structrure of the text were introduced to add clarity.
2.2. EC Funded projects
During the past years, the Commission has put considerable effort into supporting organ
transplantation. In the area of Information Society, the Commission is supporting the creation
of a European registry on organs, cells and tissues through the EUROCET project. This
project is a second phase building on the results of a previous project, EURODONOR. A
common and agreed nomenclature will make possible to compare the activity of the different
systems at EU level.
In the field of research the Commission has also been very actively involved in this area.
ALLIANCE-O, an ongoing project, is the first-ever coordination of donation and transplant
national or regional research activities across seven different EU countries, which aims to
identify the best possible framework for efficient organ donation and transplantation strategies
across Europe.
A third important project, DOPKI, has started this year focusing on improving knowledge and
developing applicable methodology that could be used to increase the potential of organ
donation. In order to achieve such an objective, the project aims to promote cooperation and
sharing of information and practices among seven EU countries.
A fourth interesting project, RISET, is based on basic research oriented to reprogram the
immune system for the establishment of tolerance to organ transplants. A filth project is
BOTIA, aims at improving the safety of blood and organ supply by creating the research
infrastructure to monitor emerging pathogens and develop new screen tests through more
cost-effective safe and inexpensive procedures.
Drucksache 16/7192 – 28 – Deutscher Bundestag – 16. Wahlperiode
A sixth project, TRIE, should start before the end of 2006 and is expected to prepare the
groundwork for a possible large-scale initiative in transplantation research in the European
Union aiming at improving coordination of national research programmes in transplantation.
This project will work closely with ALLIANCE-0."
In the area of Justice, Freedom and Security, under the AGIS program, a project is starting
that aims to compile national legislations and identify the main problems and potential
solutions to ensure the avoidance of organ trafficking. Under the Public Health Program the
Commission is finalizing the negotiation phase of a project intended to develop a EU Training
Program on Organ Donation.. A new project has been accepted for funding in 2006 aimed to
establish a European common standard framework regarding living donation.
The results of all these projects are providing a considerable amount of information useful for
active policies in this area.
2.3. Consultation of experts and stakeholders
Member States authorities in the area of organ transplantation were consulted on the draft
texts during a meeting organised in December 2005. The initiative was very well received and
the feedback was positive. Comments formulated by the various Member States experts
during were integrated into the draft texts.
In order to give stakeholders and Member States an occasion to put forward their positions
related to Organ donation and transplantation DG SANCO launched an open consultation in
the public health web site from June to September 2006. The objectives of the consultation
process have been to gather the opinions and views of the stakeholders on issues to be
included in the Communication.
The Commission received 73 contributions. Many of them, in particular the ones from
regulators, the medical community and the patients or donors associations are the results of
wider consultation.
Contributions have been received from 18 Member States (Austria, Belgium, France, UK,
Czech Republic, Finland, Sweden, The Netherlands, Denmark, Germany, Ireland, Italy,
Spain, Portugal, Latvia, Hungary, Malta, Slovenia and Poland), Norway, Switzerland,
Georgia, US and Argentina.
A full listing of all parties providing comments is given at the end of this document. The
participants can be divided into 4 categories:
– Patients or donors associations (15 contribution);
– Transplantation professionals / Scientific associations (26 contributions)
– Governmental bodies;, national ministries, national agencies of transplantation; regional
representatives, international institutions and Organ exchange organisations (24
contributions);
– Individuals (4 contributions);
– Others (4 contributions).
Deutscher Bundestag – 16. Wahlperiode – 29 – Drucksache 16/7192
All contributions received provided valuable information for the Commission’s further action
in this field. The summary report and the contributions could be found at:
http://ec.europa.eu/health/ph_threats/human_substance/oc_organs/oc_organs_en.htm
Drucksache 16/7192 – 30 – Deutscher Bundestag – 16. Wahlperiode
3. PROBLEM DEFINITION
The use of human organs for transplantation has steadily increased during the past decades.
Organ transplantation is now the most cost-effective treatment for end-stage renal failure, and
for end-stage failure of organs such liver, lung and heart, it is the only available treatment.
Transplant procedures continue to develop and in the future may offer practical treatment for
other unmet medical needs such as diabetes mellitus and some forms of malignant and
metabolic diseases.
The use of organs in therapy poses a risk of transmission of diseases to the recipient.
Infectious or cancerous diseases could be transmitted. Transmission of HIV, Hepatitis B and
C, bacteria, fungi and parasites, as well as new emergent diseases, through transplantation
have been described in scientific literature.
On the other hand, the shortage of organs is a major factor affecting transplantation
programmes. Nearly 40.000 patients are now on waiting lists in Western Europe. Mortality
rates while waiting for a heart, liver or lung transplant usually range from 15 to 30%.
An organ transplant is lifesaving and is in most cases the only available treatment. In terms of
quality and safety the benefit-to-risk ratio is a fundamental approach for organ transplantation.
Due to the organ shortage and the life threatening indications of organ transplants, the benefits
of an organ transplantation are high and more risks can be accepted than with blood or most
tissues and cells treatments. In this context the clinical doctor has an important role in the
decision on the acceptance of organs for transplantation.
Every year, a number of organs are exchanged between EU Member States. Cross border
exchanges imply that the transplantation process is carried out by hospitals or professionals
falling under different jurisdictions. However the number of organs interchanged between
Member States constitutes a low percentage of the total organs used for transplantation.
In 2003, the Commission carried out a survey on legal requirements related to organ
transplantation in the EU. The survey showed discrepancies in quality and safety requirements
within Member States2.
From 1999 onwards, Article 152 of the Treaty has enabled the European Parliament and
Council to adopt health measures setting high standards of quality and safety of organs and
substances of human origin, blood and blood derivatives. The Community has already
adopted Directives of the Parliament and the Council on blood, and on tissues and cells.
It is recognised that organs need a different approach from blood or tissues. An expert
conference on organ transplantation, held in Venice on 17-18 September 2003 organised by
the Italian government during its Presidency of the EU Council, listed the shortage of organs
and organ trafficking as the main priorities in this area and underlined that the quality and
safety aspects have to be considered fully within the framework of supply and demand for
organs.
One of the potential consequences of the scarcity of organs is the trafficking of human organs
carried out by organised criminal groups, tracking down and removing organs in developing
countries and handing them on to recipients within the European Union.
Deutscher Bundestag – 16. Wahlperiode – 31 – Drucksache 16/7192
3.1. Quality and safety
The use of organs in therapy poses a risk of diseases being transmitted to the recipient.
Ensuring the quality and safety of human organs in Europe is at the core of Community
activities in this field, as this aspect is prioritized in the Treaty of the European Union.
In this section it is revised the main risks related with organ transplantation and an analysis of
every step in the transplant process, how the introduction of measures into every step can
improve the quality and safety of organs and a overview of the situation in Member States.
The Risks
3.1.1. Transmission of Communicable diseases.
The use of organs in therapy poses a risk of communicable diseases being transmitted to the
recipient. These risks have been described in the scientific literature: Viral, bacterial, and
fungal infections have been transmitted via transplantation of organs. Several types of
protozoan and worm parasites have also been transferred via organ transplants. Because
organs cannot be subjected to sterilization steps, the risk of infectious disease transmission
remains and thorough donor screening and testing is especially important.
Although testing covers a broad range of infections, there are some of primary interest; human
immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV). A complete
revision of the main risks is provided in the Annex I.
3.1.2. Transmission of malignant diseases.
Transmission of different types of cancers through organ transplantation has also been
described3. In the Annex I there is a revision of the findings of the main international registers
that could measure the risk of tumour transmission through organ transplants.
Although the risk of tumoral transmission exists, the frequency of donors with tumors and the
frequency of transmission are low. Generally, tumors of high degree of malignancy are more
often transmitted from donor to recipient. Whereas, the transmission of tumors of low degree
of malignancy or localized tumors is much less frequent. For this reason donors diagnosed of
low-grade skin tumors with low capacity for metastasis like basocellular carcinoma and
donors diagnosed of spinocellular carcinoma without metastasis could be considered for the
donation.
On the other hand, not enough evidence exists to set a period of time in which a donor must
be free of the neoplastic disease before being accepted as a donor. This depends on the type
and features of the tumor, meaning that decisions should be specific to each case.
When considering organ donors who have a history of solid transplantation, the general
biologic behaviour of the tumour type, the histology and stage at time of diagnosis, and the
length of the disease-free interval should be considered. Additional caution must be exercised
3 Consensus Document Criteria for Preventing the Transmission of Neoplastic Diseases in Organ
Donation. Organizacion Nacional de Transplantes Spain
http://www.ont.es/Consenso?id_nodo=263&&accion=0&keyword=&auditoria=F
Drucksache 16/7192 – 32 – Deutscher Bundestag – 16. Wahlperiode
when considering specific tumour types such as melanoma, breast and lung, which are known
to have potential for unpredictable behaviour
Deutscher Bundestag – 16. Wahlperiode – 33 – Drucksache 16/7192
The different steps of quality and safety in the transplant process
3.1.3. Donor testing
To minimise the risks (described above) to the recipient, it is essential to screen donors and
establish the presence or absence of disease transmission risk in their organs. In order to
establish the standard level of donor safety, a minimum set of examinations should be
performed, but as shown in the "State of the Art" document (Project ALLIANCE-O:
deliverable 4.1), there is no consensus to day for all tests. The tests performed in most
countries are:
1. blood cell count with differential cell count;
2. antibody to HIV1 and 2;
3. hepatitis B surface antigen;
4. antibody to hepatitis C virus;
5. antibody to hepatitis B core antigen;
6. treponemal antigens (VDRL and/or TPHA); a positive result is not a contraindication
to organ procurement, but could be a marker of high risk behaviours and than
suggests to further investigate for infectious diseases;
7. CMV, EBV and toxoplasmosis are also tested routinely in a majority of countries
8. The following figure shows the biological tests used in the countries and indicates
whether these tests are carried out on a routine basis or depending on donor
characteristics2. (Bars indicate the number of countries)
25
9
27
27
17
19
27
11
23
8
2
9
1
1
6
6
1
10
4
10
1
10
5
3
7
1
10
1
1
1
1
1
1
1
1
1
1
0 5 10 15 20 25 30
Anti-HIV 1 and 2
Ag-HIV
Anti-HCV
Ag-HBs
Anti-HBs
Anti-HBc
CMV
Toxoplasmosis
Treponema
pallidum
HTLV 1 and 2
Routine Depending of the chracteristics of the donor Not required No data
As the previous figure shows, there is consensus in the use of a number of tests (Anti HIV,
Anti HCV, Ag-Hbs or Treponema Pallidum), however this does not apply for some other tests
(HTLV, Toxoplasmosis or Ag-HIV).
Drucksache 16/7192 – 34 – Deutscher Bundestag – 16. Wahlperiode
The use of authorised laboratories for carrying out the different tests is a binding requirement
in 10 countries2, although 15 more include this recommendation in technical guidelines. The
use of authorised tests for testing the donors is a binding requirement only in seven of the
countries surveyed2. However, 17 more include this provision in technical guidelines
With respect to tumour markers carried out for donor evaluation, the following figure 14
shows the different practices in the countries surveyed. There is wide heterogeneity, but the
results show clearly that few countries carry out these tests on a routine basis2.
2
2
3
3
3
15
12
13
11
10
12
15
13
15
15
0 5 10 15 20 25 30
Pregnancy Test
BHCG
PSA
Carcinoembryonic
antigen
Alphafetoprotein
Routine Depending of the chracteristics of the donor Not required
Standard laboratory tests should be conducted on all potential donors with the objective to
detect specific malignant diseases that may contraindicate the organ donation. The human
chorionic gonadotropin (HCG) beta in the urine should be determined in females in fertile age
since this hormone appears augmented in females with choriocarcinoma. Also, it’s
recommendable, when possible, to do always the determination in a blood sample.
The usefulness of other specific tumoral markers is questionable. With regards to prostate
specific antigen (PSA) as screening the adenocarcinoma of the prostate different studies have
shown its limited or null usefulness for a premature diagnosis. When selecting donors older
than 50 years it was found that only 11 of them (5.9%) had high PSA and only 2 out of those
that had high PSA confirmed the presence of adenocarcinoma of the prostate. There is a
consensus to advise against indiscriminately carrying PSA and other tumoral markers. For this
reason, there isn’t any evidence that advices the systematic realization of the PSA for the
donor evaluation 4,5,6
3.1.4. Donor Suitability
Pre-transplant evaluation of potential donors is an essential part of solid organ transplantation.
The goals are to identify conditions which disqualify donors; to identify and active infection
4 Frutos MA, Daga D, Ruiz P, Jose Mansilla J, Requena MV. Prostate-specific antigen in the assessment
of organ donors. Transplant Proc. 2003 Aug;35(5):1644-6.
5 Ruth Etzioni, David F. Penson, Julie M. Legler, Dante di Tommaso, Rob Boer, Peter H. Gann, and Eric
J. Feuer. Overdiagnosis Due to Prostate-Specific Antigen Screening: Lessons From U.S. Prostate
Cancer Incidence Trends. J Natl Cancer Inst 2002; 94: 981-990
6 Yamey G, Wilkes M. The PSA storm. BMJ 2002; 324: 431.
Deutscher Bundestag – 16. Wahlperiode – 35 – Drucksache 16/7192
pre-transplant and to define the level of risk in order to determine strategies for preventing
post-transplant effects. The differences on screening between the living donor and the
deceased donor are largely based on the different time which this screening takes place. For
the living donor it is possible to treat active infection and to defer transplant until such
infection resolves. By contract the time frame for deceased donor evaluation is typically
hours. Because of the short time frame there is a possibility that certain infections (HIV or
HVC) may be presented at an early stage, prior to the development of antibodies. Thus,
considerable weight is placed on donor social and medical history in identifying potential
risks that might not be reflected in serological testing.
Donor suitability criteria should be established according to accepted medical standards.
Donor evaluation normally includes an interview with a family or other relevant source, a
detailed review of the medical notes, assessment of the medical and behavioural history, full
physical examination, post-mortem examination (autopsy) findings, if performed, and
laboratory tests. This information should be obtained by a trained professional.
One of the conclusions of the project O-Alliance (deliverable 4.2?) are common guidelines on
suitability of the potential donor: Every donor who will undergo the process of organ removal,
must be evaluated by the intensive care operators as well as by local coordinators and
clinicians responsible for the transplant of the specific organ jointly to their reference centres
according with the procedures presented in the adopted O-Alliance safety guidelines. In
addition, a copy of protocol has to be kept and filed at the national reference centres.
The evaluation of the suitability of the donor has to be based on:
– medical history;
– physical examination;
– instrumental as well as laboratory tests; the laboratory tests should be
conducted on a sample collected before procedures which required
haemodilution;
– histological examination and/or post mortem examination with the aim to
clarify those issues emerged during the previous evaluation steps or still to be
investigated.
– The gathering of all this information is finalised to the best treatment of the
patient.
– In accordance with current knowledge the following conditions, if present, are
usually considered as complete exclusion criteria for the donor suitability:
– HIV 1 or 2 seropositivity;
– HbsAg and HDV contemporaneous seropositivity;
– Current neoplastic conditions (with a number of exceptions);
– Systemic infections caused by agents for which treatments are not feasible;
– Documented prion diseases;
Drucksache 16/7192 – 36 – Deutscher Bundestag – 16. Wahlperiode
The project concludes that benefit and risk assessment could allow the use of organs at risk
for transmissible disease and the final decision of organ suitability should rest with the
transplanting team. However, all potential donors should be referred to the donor transplant
co-ordinator for assessment. The cause of brain death must always be thoroughly investigated.
In the EU, the criteria for cadaver organ selection are regulated by technical guidelines in
most countries2 (23) with only nine having binding selection criteria in place. For the living
donor, 13 countries have binding criteria and 15 more have technical guidelines. The next
figure shows the different factors included in the risk assessment in the different countries,
and how they are regulated (binding requirements, technical guidelines or not regulated).
9
11
4
4
6
5
1
7
1
5
19
17
15
16
22
23
18
20
23
21
9
8
9
1
3
2
1
1
1
1
1
1
1
1
1
1
0 5 10 15 20 25 30
HIV risk factors
History, clinical evidence, or confirmed positive
test for HIV/AIDS
Prion disease risk factors
History, clinical evidence of prion disease
Bacterial, viral or fungal infection which is not
controlled at the time of donation
Presence or previous history of malignant
diseases.
Haemodilution of donor samples
Cause of death
Age
Ingestion of, or exposure to, a toxic substance
Legal Guidelines Not regulated No data available
Most of the risk assessment is governed by technical guidelines. Some of the common
accepted criteria such haemodilution of donor samples or risk factors for prion diseases were
lacking in a considerable proportion of countries, which do not have any kind of
law / guidelines in place.
Evaluation of the different criteria in the risk assessment is covered in technical guidelines in
most of the countries surveyed.
There are however some special situations where organ donation could be performed even if
the organ does not satisfy all eligibility criteria. These situations occur when the patients
condition becomes life threatening and transplantation is the only life-saving treatment
possible. Transplantation should be also possible in some specific clinical situations of the
recipient, certified by the transplant centre. (O-alliance project delivery 4.2)
3.1.5. Living donors
Living donors of organs will face risks associated both with testing to ascertain their
suitability as a donor and the procedure to obtain the organ, tissue or cells. Complications may
include medical, surgical, social, financial or psychological problems and, in the worst case
Deutscher Bundestag – 16. Wahlperiode – 37 – Drucksache 16/7192
scenario, could seriously incapacitate the donor or even lead to the donor’s death. As donors
are volunteers and otherwise healthy individuals, all possible measures must be taken to
minimise the risks to the donor.
3.1.6. Deceased donor management
The management of the deceased donor during the process is important not only for safety
and quality but also for maximising organ procurement. Proper donor management should
start as soon as possible after completion of death certification, and while appropriate consent
is being obtained to maximise the chance of successful organ recovery the staff involved
should have appropriate training and experience. It is recommended that a standardised
protocol for donor management be developed in each centre, including monitoring and
documentation.
3.1.7. Conditions of procurement
Allograft contamination has been described during procurement, and processing of organs for
transplantation. The procurement team has an important role for inspecting the donor in order
to complete the donor record. The maintenance of donor records and quality systems has also
been identified as key steps towards quality and safety. Standard procedures for procurement
and requirements for organ preservation and transport should ensure the best quality and
safety.
The following figures show the requirements in the different EU countries in relation with the
authorisation of organ procurement, standards for organ procurement and existence of quality
systems during the procurement phase.
19
12
9
6
1
4
19
16
9
12
6
1
1
1
0 5 10 15 20 25
Specific authorisation
for a procurement
centre
Specific authorisation
for a procurement
team
Standards for organ
procurement to be
met
Quality control
systems to be
followed
Legal
Guidelines
Not regulated
No Data
In order to maximise the benefits and minimise the risks of the transplant procedure, the
suitability of an individual donor of organs, tissues or cells should be based upon quality and
safety. Organs, tissues and cells should be retrieved and preserved within appropriate time
intervals to preserve the necessary biological functions. The time interval should be
compatible with the period it takes to perform all the relevant investigations to ensure the
quality and safety of the retrieved materials. Therefore, all these activities should be
Drucksache 16/7192 – 38 – Deutscher Bundestag – 16. Wahlperiode
undertaken according to SOPs within a quality assurance programme and should include an
appropriate risk assessment.7
The procurement team should provide a sufficient amount of preservation solution. The
solutions should be specified in SOPs and comply with existing standards. Possible
contamination of the preservation fluid should be avoided and these fluids should be
monitored with repeated samplings for bacterial culture. The required temperature should be
achieved by external cooling, and continuous monitoring of temperature in the environment of
the graft should be provided
The removed organs should be flushed with cold preservation fluid. Donor blood should be
removed as carefully as possible from the vessels of the organ, while keeping the organ cool
in order to slow down its metabolism. Acceptable cold ischemia times should be specified for
each type of organ and be kept to the minimum possible, as it is generally agreed that short
preservation time correlates with better organ function.
3.1.8. Organ processing and transportation.
Allograft contamination has been described during processing of organs for transplantation. It
also important to ensure that there is effective transportation of organs which minimises
ischemic times and avoids organ damage. While maintaining medical confidentiality the
organ container must be clearly labelled and should contain the necessary documentation.
Next figure shows how different procedures for the retrieval of the organs, their packaging,
labelling, preservation and transport, as well as how the documentation to be provided with
the organ, the quality systems and the audit of accidents are regulated in the EU. It is clear
that in the majority of countries (bars represent countries) these procedures are governed by
technical guidelines:
6
8
6
8
7
2
2
3
21
19
21
19
17
24
21
17
1
1
1
1
4
2
5
8
1
1
1
1
1
1
1
1
0 5 10 15 20 25 30
Retrieval
Procedures
Organ Labelling
Organ packaging
Documentation to
be provided with
the organ
Organ Transport
Preservation
methods
Quality system
Audit of accidents
Legal Guidelines Not regulated No data available
3.1.9. Transplantation programmes
It has been recognised by the experts of the Venice Conference that the recipient preparation,
transplant procedure and follow up are critical for the outcome. Transplant procedures should
be performed according to the state of the art, only in units which have all the necessary
7 Guide to safety and quality assurance for organs, tissues and cells. Council of Europe
Deutscher Bundestag – 16. Wahlperiode – 39 – Drucksache 16/7192
facilities and human resources to maximise the safety of the recipient. The staff involved
should have appropriate training and experience.
The authorization of establishments and programmes of organ transplantation has been
identified as one of the key elements to ensure quality and safety. The Council of Europe
recommendation Rec (2004)19 of the Committee of Ministers adopted on 15 December 2004
(6) recommends that that the governments of its member states take all necessary measures to
ensure that criteria for the authorisation of organ transplantation facilities were in place. The
recommendation considered that given that organ exchange and circulation of patients is
becoming a more frequent phenomenon, minimum common standards should be guaranteed
to the citizens.
The conclusions of the Venice conference also stressed that the evaluation of procedures and
outcomes is critical to the safety and effectiveness of transplant services. Transplant services
should submit evaluation data to appropriate registers. Member States should take appropriate
measures to ensure that a system is in place for collecting and analysing transplant follow up
data on a regular basis.
The following figures show the requirements in the different countries in relation with
authorisation of organ transplantation. The bars indicate the number of countries.
22
13
8
8
2
5
17
14
5
10
3
6
1
1
1
0% 20% 40% 60% 80% 100%
Specific
authorisation for
a transplant
centre
Specific
authorisation for
a transplant
team
Standards for
organ
transplantation to
be met
Quality control
systems to be
followed
Legal
Guidelines
Not regulated
No Data
3.1.10. Traceability and vigilance of adverse events and reactions
It is important to ensure that all transplanted material can be traced forward to recipients and
back to the donor. It is mandatory to inform the relevant contacts of donors or other recipients
about potential problems coming to light after transplantation, when relevant to their health
Twenty-five of the countries surveyed have a national register containing data on the origin
and destination of the organs; in 18 of these countries this register is legally binding. From the
countries where a register is in place, 15 have binding rules on restricted access and
confidentiality. The percentage of countries with registers in place in the different settings
(procurement sites and transplantation centres) is also indicated in figure below.
It is necessary that national organizations ensure that specimens of serum and mononuclear
cells of the donors are stored and can be reanalysed afterwards. Registers of activities in the
procurement centres or in transplantation centres are only required by law in few Member
states. Only five Member States require banking of serum samples for each donor.
Drucksache 16/7192 – 40 – Deutscher Bundestag – 16. Wahlperiode
Only in 8 countries is there a binding official mechanism for reporting of serious adverse
events. In 12 more the system is driven by guidelines. This of especial interest as already
mentioned every year, a number of organs are exchanged between EU Member States.
3.1.11. Import / exports
The regulation of the authorisation of organ imports and export from or to third counties are
not regulated in many European Member States. The bars indicate the number of countries.
These could have implications on the trafficking of organs in the Community
17
15
8
10
4
4
0 5 10 15 20 25 30 35
Is specific
authorisation
required for organ
exchange between
organisations?
How are organ
imports/exports
regulated?
Legal Guidelines Not regulated
Deutscher Bundestag – 16. Wahlperiode – 41 – Drucksache 16/7192
3.2. Organ Shortage
The severe shortage of organ donors remains the main challenge that Member States in the
European Union face with regard to organ transplantation. This section identifies the main
facts and causes of this problem.
3.2.1. Growing waiting lists
It is a fact that more than 40,000 patients are currently waiting for a kidney in Western
Europe. Waiting lists have increased in all EU countries and in the rest of countries of the
world.
Even in cases of sustained increases in the number of donors’, waiting list patients and times
are very difficult to reduce. Demand of transplant increases more and faster than organ donor
rates. However, the increase in the number of available donors will help to reduce the gap
between supply and demand if not getting an absolute reduction of the waiting list.
Average prevalence rate of end stage renal failure in Europe is around 1,000 patients p.m.p.
Among those, between 20 and 30% are accepted to the waiting list for a kidney transplant.
Annual incidence is around 140-150 new patients p.m.p., giving an average need of kidney
transplants of 50 grafts p.m.p. per year, to cover the yearly needs. This rate will stabilize the
waiting list but not decrease it, since the historical will always remain. Kidney transplant rates
over 60 p.m.p. are necessary to reduce both renal waiting patients and waiting times. An
increase in the organ donation rate up to 25 donors p.m.p. which is feasible and achievable
will not be enough, but more easily complemented with other alternatives such as living
donation.
Austria 826 Greece 775 Poland 1105
Bulgary 36 Hungary 939 Portugal
Belgium 955 Iceland Romania 1512
Czech. Republic 343 Ireland Slovak Republic 741
Cyprus Italy 8688 Slovenia 81
Denmark 384 Latvia 354 Spain 4152
Estonia 29 Lithuania 434 Sweden 503
Finland 272 Luxembourg 11 The Netherlands 1088
France 5932 Malta United Kingdom 7126
Germany 8853 Norway 174 TOTAL 45313
Table 1. Patients awaiting for a Kidney transplant by 2005; 31st December8
3.2.2. Increased demand of transplants
The excellent results of transplants during the last decade, in terms of life years gained and
improvement of quality of life, has multiplied the indications of these therapies. The tables
below show the evolution of the patients admitted to the waiting list and the number of kidney
grafted (table 2) and liver (table 3) transplants, in some European countries. It shows how the
number of patients admitted to waiting lists has increased much more than the transplants
performed.
8 Data from the Newsletter Transplant. Council of Europe- 2005
Drucksache 16/7192 – 42 – Deutscher Bundestag – 16. Wahlperiode
1989 2004
Waiting
list Transplants
Waiting
list
Evolution
% Transplants
Evolution
%
France 4.603 1957 5.380 16,8 2.127 8,6
Eurotransplant 9.445 3.172 12.251 29,7 3.948 24,4
Skandiatransplant 926 854 1.235 33,3 927 8,3
U.K. /Ireland 3.704 1.960 6.829 84 1.924 -1,8
Spain 5.024 1.039 4.026 -19,8 2.133 105
Table 1. Kidney Transplants and Waiting List Patients
1989 2004
Waiting
list Transplants
Waiting
list
Evolution
% Transplants
Evolution
%
France 183 585 460 151 833 42
Eurotransplant 180 499 2.035 1000 1.391 178
Skandiatransplant 21 65 58 176 248 281
U.K. /Ireland 51 298 271 431 665 123
Spain 90 170 631 600 1037 501
Table 2. Liver Transplants and Waiting List Patients
3.2.3. Limited donor pool
It is also clear that the need for transplants increases much more than the available organs.
There are different reasons for the shortage of donors. The majority (more than 90%) of the
organ donors are patients who died in hospitals after an irreversible cessation of all brain
functions, known as brain death. These patients are in Intensive Care Units where their
cardio-respiratory functions are artificially preserved. Less then 3% of the deaths in hospitals
are diagnosed with brain related criteria before cardiac arrest, and therefore the number of
potential organ donors is low.
There are other two other parallel groups of donors: firstly living donors (donors of single
kidney or undergoing hemi-hepactectomy ) and the so call non-heart beating donors, these are
patients in irreversible cardio circulatory arrest with a warm ischaemia time reduced enough
to allow the extraction of the organ suitable for transplant. NHBD are defined in four
categories after the Maastricht Workshop in 2005 (Masstricht riteria). However the use of
these types of donors have not been actively actively favoured in many Member states given
its ethical implications.
3.2.4. Variability in Donation rates from deceased donors
Linked with the limited donor pool it is the fact that there are important differences in the
deceased organ donor rate within the EU. These differences cannot be explained only by
differences in the general or specific mortality rates.
Austria 24.8 Greece 8.1 Poland 14,5
Bulgary 0,8 Hungary 18 Portugal 19
Belgium 23.8 Iceland 6.8 Romania 0,5
Czech. Republic 20,3 Ireland 17.6 Slovak Republic 12.1
Deutscher Bundestag – 16. Wahlperiode – 43 – Drucksache 16/7192
Cyprus 8.9 Italy 21 Slovenia 10.5
Denmark 11,9 Latvia 20 Spain 35.1
Estonia 26.9 Lithuania 10,2 Sweden 14.2
Finland 16.2 Luxembourg 6 The Netherlands 14.6
France 22.2 Malta 10 United Kingdom 12.8
Germany 14.8 Norway 16.5
Table 4. Organ donor rates (per million population (p.m.p.). 20059
3.2.5. Ischemia times.
In addition organ transplants are subject to time pressure. The process from the procurement
to the transplantation should be done in a few hours (in order to preserve the organ viability.
Safety and quality evaluation procedures will take those differences into account.
3.2.6. Compatibility donor recipient
In order for organs to be transplanted, the donor has to match with the recipient. In organ
transplants ABO (blood type) matching is required, although in some situations can be
overridden. Good HLA (human leukocyte antigens) matching between donor and recipient is
usually desirable for renal, pancreatic and small bowel transplants, but may not be required
for other organ transplants. For thoracic and liver transplant recipients, a match in body size is
an important consideration. Paediatric organs should preferably be offered to paediatric
recipients.
Kidney 24-30 hours
Liver 12-18 hours
Lung 8-10 hours
Heart 6-8hs
Pancreas 6-8hs
Order of retrieval
during
procurement
Order for
transplantation
9 Data from the Newsletter Transplant. Council of Europe- 2005
Drucksache 16/7192 – 44 – Deutscher Bundestag – 16. Wahlperiode
3.2.7. Organisational complexity
All explained above makes the organisational structure key in the organ
donation/transplantation systems. It has an important role in the quality and safety of organs
and also in their availability. The Donation / Transplantation process is complex involving
many different steps; each transplant can require many professionals and more than 20 hours
of continuous work. The process starts with the identification of the donors. After a careful
evaluation in the search for any contraindication representing a potential risk for the recipient,
all potential donors will be identified. After that comes the necessary clinical and legal
certification. In case of deceased donor during all this time the haemodynamic stability must
necessarily be maintained to preserve the viability of the organs.
In the case of the legal or social requirement of the family consent (the case in most
countries), It is needed to approach the relatives and interview them to request consent. The
necessary arrangements, both within and outside the hospital, for multiple organ retrieval
must also be made. The organs should be shared according to the previously approved
allocation criteria, and the coordinating office should provide a complete logistic support.
Once the retrieval is finished the organs will be grafted.
The distribution and exchange of organs must be organised in such a way as to distribute them
as ethically as possible, facilitating a policy of exchanges, maximising the benefit from the
organs generated and the recipient chances of a transplant. All this implies more management
standards in waiting lists and more consensus-based distribution or allocation criteria. During
this process a number of preservation solutions are used and the organ has to be maintained in
cold temperature
3.2.8. Ethical issues
There are many complex and sensitive ethical issues in this area that have could have
repercussion on the availability, and it became clear that several of these aspects are dealt
differently in Member States. It is generally accepted that the donation should be voluntary
and altruistic with legal and ethical contexts clearly defined, the data from donors and
recipients should be protected, provided that traceability is ensured, except in the case of a
living donor with a close relationship to the recipient.
Most of the Member States that responded to the Commission survey2 have legislation to
protect the donor in respect of anonymity (measures ensuring that the identity of the
recipient(s) is not disclosed to the donor or his family and vice versa); confidentiality
(measures ensuring that all data collated, including genetic information, have been rendered
anonymous so that the donor and the recipient are no longer identifiable) and non
remuneration for the donation (measures preventing organ trade or trafficking).
There is a general agreement that cadaveric organ retrieval is only allowed if some form of
consent is available from the deceased or his relatives. This is also reflected in international
guidelines; according to the additional protocol to the Convention of Biomedicine of the
Council of Europe concerning Transplantation of Organs and Tissues of Human Origin10.
Member States should ensure that there is a legal basis for ensuring valid consent or objection
10
http://conventions.coe.int/Treaty/Commun/QueVoulezVous.asp?NT=186&CM=8&DF=8/29/2
006&CL=ENG
Deutscher Bundestag – 16. Wahlperiode – 45 – Drucksache 16/7192
to organ donation. The results of the Commission survey showed that in 28 countries the
consent for a donation from the deceased donor is embedded in a binding law2. Only in one is
it organised through guidelines.
Basically two kinds of consent can be distinguished: systems of explicit consent (opting in)
and systems of presumed consent (opting out). In the former the donor himself has to
authorise organ removal after his death (in the form of an advanced directive or donor card or
by filling in a form in order to record consent in a national register). In the latter kind of
system, explicit consent is not required: it is sufficient that the deceased donor has not
objected during his life (according to national law); in that case consent is presumed.11 It has
to be noted that the dichotomy between pure opting in and opting out systems represent an
oversimplification that fails to recognise the nuances with which these systems function in
practice.
There are mainly four forms of consent found among the countries surveyed. In 8 of the
countries consent required always the agreement of those close to the deceased. 7 countries
have in place a present consent law, but the family agreement is requested if the wishes of the
deceased are unknown, in other 7 countries there are present consent law but in practice the
confirmation of the family is needed, and in the rest of the countries surveyed (7) the
presumed consent law applies and no family confirmation is needed.An important operational
aspect of consent systems (whether explicit or presumed) is the way the consent of objection
is being recorded. A growing number of European countries have established national
registers so that the information on the willingness to donate is readily available and easily
accessible for health professionals confronted with potential donors in a hospital or elsewhere.
Most of the countries surveyed2 have a register in place; in 16 the existence of these registers
is compulsory by law. There are different types of registers: dedicated registers of donors,
non-donors, combined and other types such as a register of inhabitants that incorporates also
the information about the willingness – or not - to donate or other kind of registers such as
driving license or donor cards.
24%
28%
7%
41%
Donor
No donor
Combined
Others
Regarding the consent of the living donor is also regulated by law in most of the countries2
Transparency, Equity and Accessibility – It is also generally accepted that all transplant
systems rules (allocation, access to transplant services, activity data, etc.) should be made
public and be properly controlled.
Death certification - Organ retrieval from the deceased may take place only after death
certification. Death certification should be a matter of national legally binding rules that
should be made public.
11 S Gevers, A.Janssen; R. Friele. Consent systems for post mortem Organ donation in Europe. European
Journal of Health Law 2004 (11): 175-186
Drucksache 16/7192 – 46 – Deutscher Bundestag – 16. Wahlperiode
Of the countries surveyed, 86% (25) have binding legislation in place establishing a definition
of brain death, three more have technical guidelines with definitions. As to which criteria are
needed in the different countries for diagnosing brain death, differences are in evidence as
indicated in figure 5 (the bars indicate the number of countries):
7
13
5
3
1
0
2
4
6
8
10
12
14
16
Only Clinical Clinical Plus a mandatory
test
Clinical plus a
confirmation test but only
under specific
circumstances
Guidelines
Legal
The number of doctors that have to confirm brain death also varies between the countries; in
10 two doctors have to sign the certificate, in another 10 the number of doctors needed is
three, while 8 countries require only one doctor and in one country four doctors are required.
The situation is different regarding a binding definition of death in non-heart beating donors.
Only 45% (13) of the countries have this definition in their legislation and five more in
technical guidelines.
Deutscher Bundestag – 16. Wahlperiode – 47 – Drucksache 16/7192
3.2.9. Participation of the society
On the other hand, organ donation and transplantation are the only medical treatments that
require the participation of society for their full development. One of the main reasons of the
shortage of organs is the family refusals to donation. These refusals also vary widely within
Europe:
Austria Greece 46,2 Poland 9,11
Bulgaria 33,3 Hungary 8,6 Portugal 6
Belgium Iceland 25 Romania 21,4
Czech. Republic Ireland Slovak Republic 17,1
Cyprus Italy 29,4 Slovenia 22
Denmark Latvia 19,3 Spain 16,8
Estonia 20,8 Lithuania Sweden
Finland Luxembourg The Netherlands
France 30,3 Malta United Kingdom 42
Germany Norway 33,3
They could be explained by the wide variability of procedures in the law of donor consent, for
living and deceased donors, the different practices on donor registers, and also other important
cultural, economic or social factors that influence the perception of the society of the benefit
of donation.
In 2006 a survey carried out by the European Commission12 asked to European citizens if
they have already discussed within their families the possibility of being organ donors. 58%
of the surveyed answered that they never had this discussion and 41% that they have already
talked about it. This situation is worse respect the same survey done in 200213
EB66.2, automne 2006 EB58.2,
printemps
2002
UE25 UE15 NEM10 UE15
Oui 41 44 25 46
Non 58 55 73 52
Ne sait pas 1 1 2 2
In the same survey 56% of the answers declared to be ready to donate their organs to an organ
donation service after their death, 26% were against this possibility and 18% didn’t know or
didn’t want to answer the question. There were clear differences between Member states as
the next figure shows.
12 Special Eurobarometer December 2006 Organ donation and transplantation
13 Special Eurobarometer December 2002 Organ donation and transplantation
http://ec.europa.eu/health/ph_threats/human_substance/documents/ebs_183.5_fr.pdf
Drucksache 16/7192 – 48 – Deutscher Bundestag – 16. Wahlperiode
More precisely the persons less favourable to the donation were people on retirement (49%),
those persons with more that 55 years of age (49%) and persons which have finished full time
studies before 15 years old (45%). Students (60%), persons that have suited full time at least
until 20 years of age (66%) and the executives (67%) are proportionally the more favourable
to donate.
54 % of the citizens have answered affirmatively to the question « If you were asked in a
hospital to donate an organ from a deceased close family member, would you agree? 23%
Deutscher Bundestag – 16. Wahlperiode – 49 – Drucksache 16/7192
have answered negatively and 23% « I don’t know ». Answers again widely defer between
countries.
The creation of a European organ donor card, as proposed by the European Parliament in the
context of the Opinion on first reading of 16 March 2006 on the Commission proposal for a
Health and Consumer Protection Programme, could also contribute to increasing public
awareness. Data from the eurobarometer survey in 2006 shows that 81 % of European citizens
support the use an organ donor card to make it easier to identify people willing to donate
Drucksache 16/7192 – 50 – Deutscher Bundestag – 16. Wahlperiode
organs after their death. In spite of this only 12% of Europeans have currently an organ
donation card.
3.2.10. Alternatives: Increasing the detection of deceased donors and conversion into
actual donors
The adequate supply of organs is key for high quality and safe organ transplantations. A
number of different alternatives, related to the organisation of donation systems and current
practices, could help to reduce the gap between organ supply and demand.
The combination of an efficient system for organ donor identification and detection and
procurement has been identified as a key element in increasing the cadaver donation rate in
those countries that have not reached their full potential. It has been said that many donors are
lost due to a lack of evaluation, a lack of referral or because the option of donation is not
presented to the relatives.
Different initiatives have been explored measure correctly the potential for donation in all
Member States (DOPKI project) and to increase the conversion rate of potential donors in
actual donations in Member States. Since many years, the Donor Action Foundation (DA) has
profiled itself as the only international organisation with activities in 10 European countries.
DA has organised multiple international, national and regional training courses to familiarize
users with its methodology. DA has been able to increase donation rates with 50 to 70% in
hospitals, regions and countries that have implemented the DA methodology
In many Member States, the training and employment of health care professionals responsible
for detecting potential deceased organ donors and organising the donation process has
increased the efficiency of the procurement of organs and improved the functioning of local
and national transplant systems. Such professionals can also increase the rate of donation of
tissues for transplantation. The Council of Europe has adopted a recommendation regarding
the role and training of professionals responsible for organ donation (transplant “donor co-
ordinators”). It recommends member States to appoint a professional responsible for the
identification of potential deceased organ and/or tissue donors in every hospital with an
intensive care unit, the so call “Donor co-ordinators”, should have a high standard of
professional training consistent with internationally recognised standards, to ensure the
highest possible professional and ethical standards in organ donation and procurement.
3.2.11. Alternatives: The use of living donors
The use of living donors is an increasing alternative given the failure to meet the growing
need for organs with cadaver donation. Living donation in Europe represents 17% of kidney
transplant activity and 5% of liver transplantation. The use of living donors varies widely
within Europe, from countries like Spain where they currently account for less that 4% of
transplants, and other countries, mainly in Northern Europe and North America where the
percentage of living donor transplants represents between 20% and 50% (figure below).
Although living donors have always been critical for transplantation, the use of living donors
has dramatically increased over recent years for kidney and portions of liver. The increase in
living organ donation can be attributed to multiple factors, including pressure created by the
shortage of deceased donors, surgical advances, and strong evidence of favourable transplant
outcome and low donor risk.
Deutscher Bundestag – 16. Wahlperiode – 51 – Drucksache 16/7192
There is ample evidence from world wide transplant outcome studies, that the short and long
term clinical outcome from living related donor kidney transplants are equal to or
significantly better that the overall results of kidneys transplanted from deceased organ
donors.
Living kidney donor transplantation carries some medical risks for the donor. The mortality
risk has been calculated at 1:3000. The risk of a serious, but not life-threatening complications
have been estimated to be 1-2%. However, if properly screened, there is very little risk that a
donor will suffer any long-term health problems resulting from the unilateral nephrectomy.
DOPKI project has looked into the Regulations in terms of living donation, these always
imply a restriction in order to protect the potential living donor or to prevent organ trafficking.
Hence it is only consequent that those restrictions are regulated by law since they effect the
right of the living donor do decide himself about his physical integrity and it also deprives the
living donor recipient from a possibly lifesaving treatment.
In all participating countries in the project organ trafficking is penalized and living donation
has to be altruistic.
Generally living organ donation from minors is not accepted however in some countries (UK,
Switzerland, Slovenia) exceptions can be made. The principle of subsidiarity - meaning that
living donation is only allowed if no post mortem organ is available is only applicable in three
countries. The majority of the participating countries require a specially defined relationship
between donor and recipient and thus altruistic directed or non directed living donation can
not take place in those countries. 10 out of sixteen countries have installed ethical committees
that need to approve of the planned donation or require an approval by court.
Drucksache 16/7192 – 52 – Deutscher Bundestag – 16. Wahlperiode
It goes without saying that in all countries living donation requires an informed consent of the
living donor.
3.2.12. Alternatives: The use of marginal donors
In order to increase the pool of available organs for transplantation, donor profile has changed
dramatically. In some areas more than 30% of the organ donors are over 60 years old , 20% of
them are hypertensive or 6% are diabetic. The so called “expanded or marginal donors”
showed that transplantation of those “expanded kidneys” fields a substantial survival
advantage over maintenance of dialysis14.
The critical shortage of organs, the morbidity and mortality of patients awaiting
transplantation have mandated careful reconsiderations of other potential donors who are not
ideal candidates due to positive serology or history of malignancy. Transplantation of livers
and kidneys with positive serology for hepatitis B or C into recipients with appropriate
serological and viral profile has been accepted by some transplant teams.
The use of organs from donors with malignancies has been not recommended by international
bodies15. In less than 1% of all potential donors referred and after the medical examination
we discovered the presence of an unknown malignancy during the surgical procedure. In this
situation, usually organs are discarded, however several cases affecting very specific tumors
in which the graft had already been performed, did not reveal any problem in the follow up.
The decision to use or not organs from such donors would be based upon the known
biological behaviour of those tumours, always keeping in mind the benefit not only for
individuals but also for the entire transplant community. Again, published experience is not
enough to establish safety limits in the practice. Same can be said for other hundreds of
donors with pathological findings genetic or congenital disorders, or very rare diseases or
conditions. Cooperation between countries will give bigger number of recorded charts to be
on the way of defining quality and safety practice guidelines for those cases.
An informed consent should be provided by the transplant candidate, unless their physical or
mental condition does not allow them to do so.
DOPKI project has started to search into the different regulations in the participants countries.
The table at the end of this section shows whether regulations on expanded donors are existent
within each country and if yes what its contents are.
3.2.13. Alternatives: The use of non-heart beating donors
As already mentioned there is recent evidence that developments in the screening of seriously
ill patients and changes in intensive-care practices may lead to fewer patients dying in an
intensive care unit and meeting the criteria for determination of brain death. In order to
expand the donor pool it is important to consider donations from non-heart-beating donors
(NHBD). These are donors who have suffered a cardio-respiratory arrest in which special
cooling and preservation techniques can be established in a very short period of time
(generally less than thirty minutes), although the blood flow has not been maintained
14 B. Miranda, J. Vilardell., JM: Grinyó. Optimizing cadaver organ procurement. The Catalan and the
Spanish experience. Am.J.Transpl. 2003; 3:1-8
15 International Consensus Document Standardization of Organ Donor Screening to Prevent Transmission
on Neoplastic Diseases. Council of Europe Newsletter Transplant. September 2001;Vol.6.N’1:45-51.
Deutscher Bundestag – 16. Wahlperiode – 53 – Drucksache 16/7192
permanently by a machine, under certain circumstances these people could be donors of
certain organs).
The DOPKI project has investigate the situation on non heart beating donors in several
European Countries. In four out of 16 countries – namely in Croatia, Germany, Hungary, and
Poland NHBD is legally not permitted since a completed brain death diagnosis is required
prior to organ retrieval.
Apparently in some countries there are no legal restrictions however respective programs
have not been installed. In Italy, Portugal and France – even though NHBD is not forbidden
from a legal point of view, programs are not existent or only recently under development.
From the 14 countries where non Heart beating donation is allowed by law only UK allows
donation in all categories and has also programs in place in each category.
Drucksache 16/7192 – 54 – Deutscher Bundestag – 16. Wahlperiode
Non Heartbeating Donation
Organisation Country
NHBD
legally
approved?
Maastricht Category I Maastricht Category II
Maastricht
Category III.
Maastricht Category IV.
Legally
approved
Existing
programs
Legally
approved
Existing
programs
Legally
approved
Existing
programs
Legally approved Existing
programs
./. Austria Yes * Yes No Yes Yes Yes Yes Yes Yes
Belgian
Transplantation
Society (BTS)
Belgium Yes Yes No Yes Yes Yes Yes Yes Yes
MZSS Croatia No No No No No No No No No
KST Czech Republic Yes Yes Yes Yes Yes No Yes No No
ABM France Yes Yes
Under
development
Yes
Under
development
No No Yes
Under
development
DSO Germany No No No No No No No
Yes, if brain death
diagnosis completed
No
Hu-T Hungary No No No No No No No
Yes, if brain death
diagnosis completed
CNT Italy Yes Yes No Yes No Yes No Yes No
./. Luxembourg NO No No No No No No No No
NTS Netherlands Yes Yes No Yes Yes Yes Yes Yes Yes
Poltransplant Poland No No No No No No No Yes No
OPT Portugal Yes Yes No Yes No Yes No Yes No
Slovenija-Transplant Slovenia Yes Yes No Yes No Yes No Yes Yes
ONT Spain Yes Yes Yes Yes Yes No No Yes Yes
Swisstransplant
Switzerland Yes Yes No Yes Yes Yes Yes Yes Yes
UK - Transplant
United Kigdom Yes Yes Yes Yes Yes Yes Yes Yes Yes
* law says: ..removal of organs of deceased people.. Not specifically brain death or cardiac death
TABLES FROM DOPKI PROJECT
Living Donation
Organisation Country
Regulated by
Law (In
parliamentary
Transplantation
act)
Informe
d
Consent
required
Allowed
for
Minors/pe
rsons
lacking
legal
capacity
Principle of
Subsidiarity
Requirement
for Donor-
recipient-
Relationship
Approval
by ethical
committee
Approval
by court
Altruistic/No
remuneration
Organ
trafficking
penalized
./. Austria
No; only position
paper
Yes No No No No Yes Yes
BTS Belgium Yes Yes No No
Not
mandatory
No Yes Yes
MZSS Croatia Yes Yes No No Yes Yes Yes
KST
Czech
Republic
Yes Yes Yes Yes Yes No Yes Yes
ABM France Yes Yes No No Yes Yes Yes Yes Yes
DSO Germany Yes Yes No Yes Yes Yes No Yes Yes
Hu-T Hungary Yes Yes No No Yes Yes No Yes Yes
CNT Italy Yes Yes No Yes Yes No Yes Yes Yes
./. Luxembourg Yes Yes No Yes No No Yes Yes
NTS Netherlands Yes Yes No No No No Yes Yes
Poltransplant Poland Yes Yes No No Yes
Only in
case of
non
relatives
Yes Yes
OPT Portugal Yes Yes No Yes Yes Yes No Yes yes
Slovenija-
Transplant
Slovenia Yes Yes
Yes,with
obligations
Yes Yes Yes Yes Yes
ONT Spain Yes No Yes No Yes Yes Yes Yes
Swisstranspla
nt
Switzerland from 2007 Yes
Yes, with
some
obligations
No Yes Yes Yes Yes
UK -
Transplant
United
Kigdom
Yes Yes Yes, rare No No
Yes, from 1
September
2006 all
living
donations
will be
approved by
the Human
Tissue
Authority.
Yes Yes Yes
Deutscher Bundestag – 16. Wahlperiode – 55 – Drucksache 16/7192
Extended Criteria Donor
Organisation Country Do regulations exist defining ECD and their utilisation? Age limits for Donors? If Yes, what age?
Kidney Liver Heart Lung Pancreas
Austria Not regulated.
BTS Belgium No, age relative contra indications are set down in Eurotransplant manual. no no no no no
MZSS
Croatia
Yes, regulations exist. They are also established by The ordinance on measures to assure
the safety and quality of parts of the human body for medical use ( consistently with
“Guide to safety and quality assurance for organs, tissues and cells” from The Council of
Europe, see attachment!!!), and by National guidelines for treatment, allocation and
preparing of potential patients for kidney transplantation
KST Czech
Republic Not regulated.
ABM
France
There is one protocol on double kidney transplantation; There is specific rules for organs
harvested in a donor positive for HCV or HbV and syphilis No No No No No
DSO
Germany
Criteria for allocation limitations:Organs from donors with grave prior diseases (e.g. history
of malignancy) or complications resulting from these diseases require a special allocation
procedure.For example expanded donor criteria are given when the donor suffered of one
of the following diseases:- viral hepatitis (alternatively HBS Ag+, anti-HBC+ or anti-
HCV+)- sepsis with positive blood-culture- malignant tumour in medical history- drug
abuse. Specified criteria for extended donor criteria are only existent for liver
transplantation such as (alternatively): - Age of donor > 65 years- ICU-treatment including
artificial respiration > 7 days- donor adipositas >BMI.>30- fatty liver (histologically
affirmed) > 40 %- Sodium>165mmol/l - SGOT or SGPT >3x average (last parameter
before notification as donor) or- S-Bilirubin >3mg/dl (last parameter before notification as
donor) Each individual case has to be evaluated by the physicians involved in the organ
retrieval in order to determine whether the extended donor criteria are fulfilled or not.
Different allocation mechanism according to centre and patient profile
No No No No No
Hu-T Hungary Not regulated. Donor criteria are summarized in guidelines. No No No No No
CNT
Italy
YES, national guidelines exist for safety and give allocation limitations - There is no age
limit that needs to be followed by coordinators but transplant teams are free to decide case
by case
No No No No No
./. Luxembourg No No No No No No
NTS Netherlands YES, non-heartbeating donation, EurotransplantSeniorProgram (old for old) No No No No No
Poltransplant
Poland
There are also such guidelines issued in Poltransplant’s Manual. They are organ specific and
are different depending on the organ retrieved. The English version is not readily available No
Yes,
60 Yes, 60 Yes, 60
Yes, > 50
and < 5
OPT Portugal No Yes, No Yes Yes Yes
Slovenija-
Transplant Slovenia There are guidelines in the Sloveniatransplant manual No No No No No
ONT Spain Organ Specific guidelines No No Yes, <
60
Yes, <
60
Yes, < 55
Swisstransplant
Switzerland
Included in the kidney allocation rules, we speak there about handicap kidneys, the
recipients have to sign a consent form for a marginal organ No no no no no
UK - Transplant United
Kigdom No - risk/benefit assessed by local teams No No No No No
Table from DOPKI project.
3.3. Organisational Systems
1.Organisational structures have not only an impact on quality and safety of organs but also
on the detection, referral and hence the availability of organs. The organizational structure is
key in the organ donation/transplantation systems. There is a need for a well organized and
effective transplant system. This system needs an appropriate legal framework, a good
technical approach and organizational support.
The DOPKI project has evaluated these organisational systems in many European Countries:
As can be seen in the Table (From DOPKI project) below all participating organisations are in
charge of the coordination of organ donation. Only a very small percentage of countries that
have installed a national organ procurement agency are not in charge at the same time for
organs and tissues. These results coincide with those from the Commision Survey: most of the
organ transplantation organisations are also in charge of the activities of human tissues (82%
of them) and in a low percentage (57%) they also deal with haematopoietic progenitors.
Drucksache 16/7192 – 56 – Deutscher Bundestag – 16. Wahlperiode
Organisation Country Organs Tissues Cells Others
./. Austria ./. ./. ./. ./.
BTS
Belgium Yes Yes
Yes (but
not
mention
ned in
the law
1986)
./.
MZSS Croatia Yes Yes ./. ./.
KST Czech Republic Yes Yes ./. ./.
ABM
France Yes Yes Yes
Assisted reproductive
technologies; embryo
research; genetic
testing
DSO Germany Yes
New law
pending
./. ./.
Hu-T Hungary Yes ./. ./. ./.
CNT Italy Yes Yes Yes ./.
Luxembourgtransplant Luxembourg Yes Yes Yes ./.
NTS Netherlands Yes Yes No ./.
Poltransplant Poland Yes ./. Yes ./.
OPT Portugal Yes Yes Yes ./.
Slovenija-Transplant Slovenia Yes Yes Yes ./.
ONT Spain Yes Yes Yes ./.
Swisstransplant Switzerland Yes ./. Islets ./.
UK - Transplant United Kigdom Yes Yes ./. ./.
ET Netherlands Yes ./. ./. ./.
Field of Activity
Most of the 29 EU countries surveyed in the Commission survey have a national public body
(25) in charge of the organ transplantation / organ exchange. Some countries (3) have also this
type of structure decentralised in regional bodies. Others (14) have in addition an international
organisation in charge of some of the functions.
The majority of organisations is of public character. In Germany and Switzerland private non
profit organisations have been mandated by the Ministry of Health in Germany and by state
contract in Switzerland (Netherlands) to coordinate the donation and procurement activities.
Most of the organisations have a national headquarter but additionally also a regional
structure. An overview is given in table 2 (From DOPKI project)
Table: Field of activity of the organisations participating in this project
Deutscher Bundestag – 16. Wahlperiode – 57 – Drucksache 16/7192
Organisation Country Private Public Supranational National Regional
./. Austria ./. ./. ./. ./. ./.
BTS Belgium ./. Yes ./. Yes ./.
MZSS Croatia ./. Yes ./. Yes ./.
KST Czech Republic ./. ./. ./. Yes 7 regional
ABM France ./. Yes ./. Yes 6 ABM
DSO Germany Yes ./. Yes 7 DSO-Regions
Hu-T Hungary ./. Yes ./. Yes 4 Regions
CNT Italy ./. Yes ./. Yes ./.
Luxembourg Transplant Luxembourg ./. Yes ./. yes ./.
NTS Netherlands Yes ./. Yes
Poltransplant Poland ./. Yes ./. Yes ./.
OPT Portugal ./. Yes ./. Yes GCCOT -5
Slovenija-Transplant Slovenia ./. Yes ./. Yes ./.
ONT Spain ./. Yes ./. Yes ./.
Swisstransplant Switzerland Yes ./. Yes ./.
UK - Transplant United Kigdom ./. Yes Yes ./. ./.
ET Netherlands Yes ./. Yes ./. ./.
Structure
One could conclude that. two different models are present in the EU: one consists of law-
approved, institutional-centered, national transplant organizations (NTOs) based on the
principle of local and regional coordination, whereas the other consists of multinational organ
exchange organizations (OEOs) whose main objective it is to allow for adequate donor-
recipient matching through international organ sharing. In light of these two different models,
the EU transplant geography can be split into two areas: countries with NTOs based on the
principle of local and regional coordination - such as Spain, Italy, France, and Portugal - and
countries grouped into multinational exchange organizations, such as Eurotransplant
(Germany, Austria, Belgium, The Netherlands, Luxembourg, Slovenia, and Croatia) or
Scandiatransplant (Denmark, Sweden, Finland, and Norway). Even among those nations that
have recently joined the EU, some have opted for a NTO-like model (Poland, Hungary), while
other, smaller countries have gathered in an OEO-like fashion (Balttransplant for Estonia,
Latvia and Lithuania).
What is really essential to the NTO-like model adopted in Spain, Italy and France and differs
from the OEO-model currently working in Central and Northern Europe is a different concept
of transplant organization. In a NTO model, transplantation is not simplistically a mere
medical discipline, but a complex healthcare process requiring active participation from
healthcare professionals, stakeholders and local/regional/central authorities. With the
exception of UKTSA (the UK Transplant Service Authority), virtually all major NTOs are
centrally-governed, institutional organizations, officially endorsed by public laws and/or bills
and in charge of disciplining, monitoring of and planning of all donation and transplantation
activities within their borders.
2. In addition there are examples of European organisations are already in place, which proves
the need and importance of wider –European- cooperation
The Council of Europe, which groups together 46 countries, including 21 countries from
Central and Eastern Europe, has been actively involved in this area. The Committee of
Experts on the Organisational Aspects of Co-operation in Organ Transplantation (SP-CTO)
was set up following the 3rd Conference of European Health Ministers in Paris in 1987 on the
ethical, organisational and legislative aspects of organ transplantation.
Drucksache 16/7192 – 58 – Deutscher Bundestag – 16. Wahlperiode
The Eurotransplant International Foundation is responsible for the mediation and allocation of
organ donation procedures in Austria, Belgium, Germany, Luxembourg, the Netherlands and
Slovenia. In this international collaborative framework, the participants are all transplant
hospitals, tissue-typing laboratories and hospitals where organ donations take place. The
Eurotransplant region numbers well over 118 million inhabitants.
As mentioned previously, every year a number of organs are exchanged between EU Member
States. Cross border exchanges imply that the transplantation process is carried out by
hospitals or professionals falling under different jurisdictions. However the number of organs
interchanged between Member States constitutes a low percentage of the total organs used for
transplantation. However the establishment of Eurotransplant is perhaps an example of how
this situation could change if the adequate organisation is in place, the exchange rate of
kidneys between partners countries has ranged from 5% for 6 HLA mismatches to 42.8 % for
0 HLA mismatches (23 % of all transplants with and average exchange rate of 19.7%) over
the last five years. (EUROCET D7.2)
Scandiatransplant is a Nordic organ exchange organisation and it covers a population of 24
million inhabitants in five countries. According to the by-laws, the purpose of the
Scandiatransplant association is fourfold: (1) Scandiatransplant shall effect the exchange of
organs and tissue between the participating transplant centres; (2) It shall operate a database
and communicate information from it; (3) It shall contribute to promoting the provision of
human organs and tissue for transplantation; (4) It shall support scientific activities.
Scandiatransplant was founded in 1969 on the initiative of Nordic pioneers within the organ
transplantation field.
Two other organisations can be considered as having international scope: Balttransplant, an
NGO operating in Estonia, Latvia and Lithuania, and UK Transplant which scope is extended
to UK and Ireland.
On April 2004 the Ministers of Health of Italy, Austria, Cyprus, Czech Republic, Estonia,
Hellenic Republic, Hungary, Latvia, Lithuania, Malta, The Netherlands, Poland and Slovak
Republic signed the Prague Declaration which declared, among other things, the constitution
of the European Transplant Network to be the official intergovernmental organisation of
participating countries, designated for mutual cooperation in the field of organ and tissue
donation and transplantation. Members of ETN are the new Member States of the EU plus
Italy Greece and Austria. The organization is open to any country who would like to join it,
and Croatia has applied recently. The organization was founded with the aim of establishing
close collaboration and exchange of experience among the members in different aspects of the
sector for achieving higher standards of efficiency of the involved organizations, which so far
present different levels of development.
Finally the main European organ exchange organisations (EOEOs) (Eurotransplant, Swiss
transplant, Italian Transplant Centre, Hungaro transplant, UK Transplant, Organização
Portuguesa de Transplantação, Etablissement Français des Greffes, Skandiatransplant,
Poltransplant, Greek transplant organisation and the Spanish Organización Nacional de
Transplantes, ) meet on a regular basis. These organisations have already stressed the need to
analyse the differences between the EU countries in the accreditation / authorisation /
licensing / registration systems (training of professionals, authorisation of centres and
transplant programmes, import/export…etc) and the consequences of these differences in the
availability of organs and their quality and safety.
Deutscher Bundestag – 16. Wahlperiode – 59 – Drucksache 16/7192
3.Even among EU countries with well-developed services, there are considerable differences
in organ donation and transplantation activity and it seems that some organisational models
are performing better than others. In some countries the transplantation activity exceeds 80
transplanted organs pmp, compared to others with a rate of 40 pmp, and these differences are
not necessarily explained by the donation rates. As a matter of example the next figure shows
the European activity on liver transplantation in 2005 (data from the Council of Europe).
The DOPKI project is looking into the different performances of transplant systems of the
countries participating in the project as it seems that the way transplant procedures are carried
out vary between member states; e.g. in some countries the rate of non- renal transplanted
organs exceeds the number of kidney transplants, whereas at the other extreme the rate of all
other organs is only 20% of the kidney transplant rate. These differences can not be explained
by the incidence of the major causes of death or the incidence of end organ failure in the
population.. As two examples taken from the current work of the project it has studied the
differences between countries of the percentage of multi organ donors. Multiorgan donation
should be encouraged and realized whenever possible. Some statistics indicate that this is
often not done.
Drucksache 16/7192 – 60 – Deutscher Bundestag – 16. Wahlperiode
PTSIPLNLLUITHUHRFRESDECHBEAT
M
ul
tio
rg
an
do
no
r/e
ffe
ct
iv
e
do
no
r [
%
]
100
95
90
85
80
75
70
65
60
55
50
45
40
35
30
7978
39
8485
88
40
82
96
83
77
8486
77
Figure14: Percentage of multi organ donors out of effective donors across countries (mean
2003-2005)
In 12 of the 14 countries studied, the percentage of multi organ donation is around 80 %.
Multi organ donation requires that at least two different types of solid organs have been
retrieved for transplantation purposes. Another type of efficiency rate studied is to determine
how many organs where grafted per effective donor on the average. In 11 out of 15 countries
that made this data available to us more than 3 organs where grafted per effective donor.
PTUKSIPLNLLUITHUHRFRESDECHBEAT
O
rg
an
s
gr
af
te
d
pe
r e
ffe
ct
iv
e
D
on
or
4,0
3,5
3,0
2,5
2,0
1,5
1,0
,5
0,0
3,0
3,6
3,9
2,5
3,83,7
3,2
2,3
3,0
2,9
2,5
3,4
3,63,63,6
Number of organs per effective donor across countries (mean 2003-2005)
Also the number of transplant centres per population differs widely. For example, the number
of liver transplantation centres vary from more that 0.5 centres per million of population in
Belgium to less that 0.1 in Hungary or no centres in some Member States. That should be
considered given the relation between the accessibility to organ transplantation and the
donation rates.
Number of transplant programs to date 31.12.2005
Countries KIDNEY LIVER HEART LUNG PANCREAS BOWEL TOTAL
Austria 5 3 3 3 3 0 17
Belgium 8 6 7 4 7 0 32
Croatia
Germany 42 25 26 15 25 4 141
Deutscher Bundestag – 16. Wahlperiode – 61 – Drucksache 16/7192
Spain 42 23 17 7 11 3 104
France 44 24 26 15 14 4 127
HR 4 1 1 0 2 0 7
Hungary 4 1 1 0 2 0 8
Italy 40 21 19 12 15 3 110
Luxembourg 1 0 0 0 0 0 1
Netherlands 9 3 3 3 2 0 20
Poland 18 6 2 3 4 0 33
Switzerland 1 1 1 0 0 0 3
United
Kingdom 26 7 7 6 9 3 58
Cech
Republic
Portugal 8 3 4 1 1 0 17
4. As part of this organisation, an effective allocation system is essential. This system has to
take into account the short time that organs can be maintained in good conditions prior to
transplantation, and the necessity to ensure that the organ is assigned to the most suitable
recipient, according to predefined criteria.
In 17 of the countries surveyed2, the allocation criteria for organs are legally binding. These
allocation criteria normally refer to clinical criteria (medical situation of the recipient,
compatibility, time in the waiting list) and geographical criteria (to reduce the time of
ischemia and the efficiency of the process).
The majority of the countries where information is available (we do not have information on
this in 10 countries) use a combination of these two types (12 countries). In five countries the
criteria are only clinical and in two only geographical criteria are used. The responsibility of
establishing the allocation criteria is distributed as indicated above (percentage of countries).
These criteria are public in most of the countries (26) 2 (in one country data are not available).
Also in most of the countries the organ transplantation organisation is responsible for
56
26,3
32
85,2
0
10
20
30
40
50
60
70
80
90
Clinical criteria Geographical criteria
Medical professionals
Goverment
monitoring compliance with these criteria (26). Changes in the allocation criteria are
permitted in most of the countries (21), these changes are based in 72% of the countries on the
Drucksache 16/7192 – 62 – Deutscher Bundestag – 16. Wahlperiode
probability of the transplant for different groups of patients (depending in the age, blood
group, place at resident, etc…).
The inclusion and exclusion criteria for waiting lists are governed mainly through technical
guidelines, with only few countries having binding criteria2, as is shown below
7 6
21 22
1 1
0
5
10
15
20
25
30
35
Criteria for inclusion on the
waiting list
Criteria for exclusion on the
waiting list
Not regulated
Guidelines
Legal
3.4. Rational for EU action
In areas which do not fall within its exclusive competence, the EU may only act if and in so
far as the objectives of the proposed action cannot be sufficiently achieved by the Member
States and can therefore, by reason of the scale or effects of the proposed action, be better
achieved by the Community (article 5 EC Treaty). This principle of subsidiarity has been
invoked frequently in relation to initiatives on health care provision and financing.
The Treaty itself in its art. 152.4 a) provides expressly the possibility for the EC to adopt
harmonising measures to ensure Organ safety and quality of organs. National legislations
differ between Member States. A national approach could not ensure the same minimum
standard of quality and safety for organs.
Organ interchange is already taken place in Europe. In the Eurotransplant area the average
exchange rate of kidneys between partners countries was around 20% over the last five years.
The Eurotransplant region covers 118 million inhabitants. Common quality and safety rules
are needed in this context.
The example of Eurotransplant shows that once a common organisation and common rules are
in place, the number of organ exchange increases and contributes to maximize the opportunity
for patients to obtain the best possible organ. It also contributes to avoid that potential donors
are not considered because the lack of suitable recipient at that moment in the national waiting
list.
There was identified the need to develop systems for offering exchange of organs for urgent
patients and difficult recipients (e.g. children, highly sensitized patients). These patients can
not be adequately treated in small member states with limited donor pool, and can clearly
benefit from an EU initiative. In order to establish such a system common quality and safety
standards should be in place.
Also the movement of donors should be considered (e.g. In Spain close to 10 % of the donors
last year were foreigners (more than 50% of these were Europeans) and this tendency has
Deutscher Bundestag – 16. Wahlperiode – 63 – Drucksache 16/7192
steadily increased in the last years from 2 % in 2000. Cooperation to introduce initiatives that
facilitate information to citizens about the different donation systems in Europe and facilitate
these donations of foreign citizens will have an added value.
The exchange of organs is not the only "European issues" that justifies a common set of basic
standards, also the movement of patients. Having common binding standards of quality and
safety will be the only mechanism to ensure a high level of health protection all along the EU.
It is also important to consider the link with the quality and safety requirements for tissues
and cells. Many times an organ donor is also a tissue donor. Currently the Directive on quality
and safety covers the traceability and the Tissue and cells adverse event/reaction reporting but
not the organ side. These systems should be linked, even if organs are not largely cross border
exchanged, tissues and cells are. An adverse reaction in an organ donor recipient should be
traced and reported on the tissue vigilance system (already foreseen under the tissues and cells
directive) if needed.
DONOR
Recipient Recipients
Tissues
and cells
Organs
Directive 2004/23/EC
Recipient
Recipient
Recipient
Recipient
No legal framework
Drucksache 16/7192 – 64 – Deutscher Bundestag – 16. Wahlperiode
This is in close relation to the fact that organ shortage is a common dilemma in all European
countries, and that sharing of best practices, best models and expertise across the EU
members has already proved useful in increasing organ donor rates in some countries.
This is of particular interest because the experience shows how some organisational models
are performing clearly better than others. Identifying those elements in the different systems
(appropriate legal framework, good technical approach or organizational support) that could
be promoted at community level will bring a clear European added value, in particular for
those member states with less developed systems.
In addition European cooperation is imperative on the evaluation of measures intended to
increase organ donation such the use of the so call expanded donors. Again, published
experience is not enough to establish safety limits in this practice. Same can be said for other
hundreds of donors with pathological findings genetic or congenital disorders, or very rare
diseases or conditions. Cooperation between countries will give bigger number of recorded
charts to be on the way of defining quality and safety practice guidelines for those cases. This
is linked to the need of develop of consensus guidelines and professional standards to ensure
good medical practices or the evaluation of post transplant results “organovigilance” to lead to
a safer and more effective use of organ donors. This can be addressed more efficiently with a
community perspective.
Deutscher Bundestag – 16. Wahlperiode – 65 – Drucksache 16/7192
4. OBJECTIVES
In response to the issues outlined in the previous section, the general objective of the EU The
main objective of the EU is to ensure high standards of quality and safety for human organs
used in therapy at Community level as reflected in Article 152 of the Treaty. This overall
objective should be linked to specific objectives related to the main problem identified by the
experts in this area, the shortage of organ donors. In order to address adequately the quality
and safety aspects an integrated approach is needed, therefore it will be equally important to
analyse actions at EU level to increase the availability of organs use in therapy and to promote
the accessibility to these therapies in the Community.
The main objectives are represented in the figure below:
Ensuring quality and safety and increasing organ availability are the two main goals of the
proposal and should not be addressed separately. Quality and safety is in the core of the
Treaty (Article 152). Actions on quality and safety could have an effect on organ availability.
There is an important trade-off to consider in this respect.
On the other hand, the availability has also impact on the quality and safety. Maximising the
donor pool will allow to select the best organ for the patient in need.
Avoiding organ trafficking is important because any criminal on ethically doubtful activity in
this area would undermine the trust of the population of the donation-transplantation process.
A loss of trust can seriously lower the donation rates. Ilegal trafficking could also undermine
the quality and safety of the process. In the other hand organ trafficking is a consequence of
the scarcity of organs, actions oriented to increase organ availability will help to combat organ
trafficking.
The operative objectives are detailed in section 7.3.1.
5. POLICY OPTIONS
In June this year DG SANCO launched an open consultation on organ donation and
transplantation. The aim of the consultation was to identify the main problems encountered in
organ donation and transplantation, to invite ideas on EU initiatives that could help to solve
these problems, and to determine the extent to which measures should be taken at Community
level.
In the consultation, 3 possible scenarios were outlined for future EU action with regard to
organ donation and transplantation:
Main objective: High level of human health protection (Article 152 of the Treaty)
Ensuring quality and
safety
Increase organ
availability
Avoid Organ
trafficking
Drucksache 16/7192 – 66 – Deutscher Bundestag – 16. Wahlperiode
– To maintain the status quo, continuing certain basic projects already being carried out
under different EU programmes without any further coordination.
– To establish an EU structure that would promote active coordination between Member
States on organ transplantation e.g. establishing guidelines for quality and safety standards;
sharing experiences and best practice; promoting European registers on transplantation;
identifying the main problems at EU-level when it comes to organ exchanges; and
reviewing the legal framework on organ trafficking.
– To implement an open method of coordination between Member States in which they
would work together on the actions outlined in Point 2 above, while the Commission
would consider EU legislation to complement and reinforce these actions. A Directive on
quality and safety could be an option, along with legislative proposals against organ
trafficking.
a) First level: Further work under existing Community programmes.
This option will mean continuing the current work under the different Community
programmes (Public heath, Research, Information Society and Justice, freedom and security)
to support this area, without any further coordination.
b) Second level: Active coordination between Member States on organ quality, safety
and availability.
Article 152.4 constitutes the legal basis for the EC to adopt common measures to ensure high
standards of health and safety of organs. Within this framework, Member States remain
responsible for a number of significant issues linked to quality and safety, particularly with
respect to the organisation of donation systems and health care.
The use of an open method of coordination, specifically adapted to this concrete field, and as
a complement to the legislative framework, will provide the necessary policy mix to achieve a
gradual approach to the development of an EU policy. This approach will be based, in the first
stage at least, on the identification and development of common objectives for which it is
agreed that a Community response is necessary, on agreed quantitative and qualitative
indicators and benchmarks, regular reporting and identification of best practices.
Actions:
Coordination on organ transplantation activities between Member States. These could include
– Identifying standards of quality and safety.
– Putting a system in place to facilitate the transmission of the full donor record -a common
basic set of donor data- and other relevant information within Europe.
– Sharing experiences and best practices on establishing efficient systems for organ donor
detection and procurement.
– Promotion of on-going training of professionals as a key element in this process.
– The cooperation between countries leading to the compilation of sufficient information
will assist in determining the acceptable levels of risk in the use of expanded donors.
Deutscher Bundestag – 16. Wahlperiode – 67 – Drucksache 16/7192
Promoting EU registers on transplantation or cooperation between national registers should
be one of the priorities.
– International co-operation on the promotion of organ donation is desirable to help increase
public awareness, maximise organ donation, and equalise access to transplantation between
countries. Governments should actively promote such co-operation.
– Identifying the main problems at EU level for the interchange of organs and patients.
Systems for offering excess organs to other countries should be developed and in particular
exchange of organs for urgent patients and difficult recipients (children, highly sensitive
patients, ect).
– Exchange of patients, reimbursements of costs, common transplant lists, admission criteria,
prevention of registration on multiple transplant lists, among other subjects, need
discussion.
– Agreeing a common ethics code on organ transplantation.
c) Third level. Second level + Minimum harmonisation on quality and safety + Initiative
on Organ trafficking
It could be proposed that this open method of coordination should be implemented for an
initial period upon which an evaluation on the need for a Directive on quality and safety is
undertaken. After this “phasing in period” and in the light of the evaluation of the
implementation of the coordination method, the introduction of additional legislative
instruments should be considered. It could also be proposed that the coordination method
starts in parallel with the elaboration of legislative instruments. In any case, an impact
assessment shall be performed before deciding on the appropriateness to the introduction of
additional legislative instruments
This option builds on the previous level. In addition to the actions described, it incorporates
appropriate community legal instruments in order to ensure there are comparable basic levels
of quality and safety throughout Member States.
Actions:
1) EU Directive on Quality and safety for the donation, procurement, testing, preservation,
transport and distribution of human organs, under Article 152 of the Treaty
– Establishing common quality and safety standards for the
authorization/accreditation/licensing of establishments and programs of organ donation and
procurement.
– Ensuring quality management system, with a description of the standard operation
procedures.
– Having a basic set of donor information and a system in place to facilitate the transmission
of information within Europe, so that a proper risk benefit analysis can be made by the
transplant team independent of the origin of the organ.
– Ensure effective preservation and transportation of organs to minimise ischemic times and
avoid organ damage.
Drucksache 16/7192 – 68 – Deutscher Bundestag – 16. Wahlperiode
– Ensuring traceability and the reporting of serious adverse events and reactions.
2) Follow up the Greek initiative based on the results of the Europol report to evaluate how to
tackle at least partly the issue of organ trafficking in the EC proposal based on art. 152.4 of
the Treaty or to explore other possible initiatives to be undertaken on the basis of art. 29,
31(e), and 34(2)(b) of Title VI of the EU Treaty (third pillar)
6. ANALYSIS OF IMPACTS
6.1. Political impact
In 1958, the Council of Europe’s Agreement No 26 on the exchange of therapeutic substances
of human origin became the starting point for cross-border activities in this field. While
specifically referring to human blood and its derivatives, provisions were made for the
Agreement’s extension to cover other therapeutic substances. Its main purpose was to
facilitate exchanges of human substances between Member States of the Council of Europe in
cases of urgent need and under the expressed condition that no profit was made. In 198616,
the European Community became a contracting party to this Agreement. Subsequent
agreements, recommendations and guidelines that have emanated from the Council of Europe
for more than fifty years17 are the starting point for what now occurs in relation to safety and
quality of substances of human origin in Europe.
In the resolution of the Council of ministers for health in 199118 concerning fundamental
health choices the Council took note that the analysis of the Community’s possible
contribution concerning the availability of organs for transplants was identified as one of the
topics which warrant join consideration, regular joint discussions and/or joint efforts to assist
MS in framing their health policies.
In its 1994 report19 the Commission recommended the development of a blood strategy as a
way towards restoring the confidence of Community citizens in the safety of the blood
transfusion chain and fostering the goal of self-sufficiency. Council adopted the elements of
this strategy in its 1995 Resolution20.
The reports throughout the eighties of blood contaminated with the human immunodeficiency
virus (HIV) were undermining the public’s confidence in the blood supply while at the same
time, public health experts were continuing to try to prevent the transmission by blood and
other substances of human origin of the main types of infectious agents – viruses, bacteria,
and parasites.
16 Council Decision 86/346/EEC, OJ L207, 30.07.1986, p.1
17 Genetet, B. Blood transfusion: half a century of contribution, Council of Europe Press, September 1998.
55p.
18 Resolution of the Council and the Ministers for health, OJ C304 23/11/1991 p5-6
19 Communication from the Commission on blood safety and self-sufficiency. COM(94) 652 final of
21.12.1994.
20 Council Resolution of 2 June 1995 on blood safety and self-sufficiency in the community, OJ C164.
30.6.95. p. 1.
Deutscher Bundestag – 16. Wahlperiode – 69 – Drucksache 16/7192
The year 1997 was to see the Commission take a major step forward when it presented its first
proposal21 under Article 129 of the Treaty of Maastricht. Adopted as a Council
Recommendation22, it aimed to set forth common criteria for the acceptance of blood and
plasma donors as well as a set of screening tests that should be carried out in all Member
States, whether the donation was intended for transfusion or for further manufacturing into
plasma-derived products.
However, it was the entry into force of the Treaty of Amsterdam that was to provide the
Community with an opportunity to put into place a more coherent legislative framework to
address the elements that had been set out in the blood strategy and to ensure a high level of
safety for both donors and recipients. From 1999 onwards, with the adoption of the Treaty of
Amsterdam, Article 152 has explicitly enabled the European Parliament and Council to adopt
health measures setting high standards of quality and safety of organs and substances of
human origin, blood and blood derivatives.
The Community has already adopted Directives of the Parliament and the Council on blood23
in 2003 and on tissues and cells24 in 2004. These laws have been followed by the adoption by
the Commission (through the comitology procedure) of technical directives25,26,27,28 during
the last years; the next step is to establish a set of non-binding initiatives to assist Member
States to reach a consistent level of competence and performance.
The third step in this process would be to ensure the quality and safety of human organs. The
European Parliament has already pushed to include organs in the scope of the tissues and cells
Directive. At that time the Commission already recognised that organs needed a different
approach from blood or tissues. Given the shortage of organs, the quality and safety aspects
have to be considered fully within the framework of supply and demand.
This Commission Communication is responding to the mandate of the Treaty, which has been
requested by the European Parliament and the Council of ministers. Furthermore, this
Communication could support Member States in their efforts to strengthen public health
policy and contribute to a better multi-stakeholder cooperation.
This is in close relation to the fact that organ shortage is a common dilemma in all European
countries, and that sharing of expertise across the EU members has already proved useful in
increasing organ donor rates in some countries. However, if the EU is pivotal to higher organ
donation rates and more favourable results of organ transplantation, transplantation itself is
paramount to Europe. Transplantation might contribute to reinforce the idea of Europe
throughout its borders, to rekindle the spirit of community, especially after the recent
enlargement of its members number. Transplantation requires striving for common objectives,
sharing of experiences, active participation, and knowledge exchange. In a sense,
21 Commission proposal for a Council Recommendation on the suitability of blood and plasma donors and
the screening of donated blood in the European Community. COM(97) 605 final of 17.11.1997.
22 Council Recommendation 98/463/EC. OJ L 203, 21.07.1998, p.14.
23 OJ L 33, 8.2.2003, p. 30–40
24 OJ L 102, 7.4.2004, p. 48–58
25 OJ L 91,30.3.94, p25-39
26 OJ L 256, 1.10.2005, p 32-40
27 OJ L 256, 1.10.2005, p 41-48
28 OJ L 038 , 09/02/2006 P. 0040 - 0052
Drucksache 16/7192 – 70 – Deutscher Bundestag – 16. Wahlperiode
transplantation is a field where the ideals that laid the foundation of Europe are put into
practice and may stand the test of time.
6.2. Economic impact
1) Treatment Costs: Diseases that can be treated or cured by transplantation usually carry a
significant burden of morbidity and mortality, and therefore they have a significant impact on
the national health care budgets. It is estimated that, at present, more than 3% of health care
budgets of European Member Sates are dedicated to patients waiting for a transplant.
Organ transplantation provide the possibility of saving lives and also has the best cost /
benefit ration in terms of economic gains as well as quality of life. It has been calculated that
each 10,000 renal patients living with a functioning kidney graft are saving to health systems
over 200 million € annually (in terms of differences of the economical costs of the different
replacement therapies for end stage kidney patients, when comparing cost of transplantation
versus costs of dialysis treatments). The average prevalence rate of end stage renal failure in
Europe is around 1,000 patients p.m.p. Among those between 20 and 30% are waiting for a
kidney. Annual incidence is around 140-150 new patients p.m.p. This is just taking into
account daily dialysis costs and not including structural costs.
Cost-saving and cost benefits referred to Qualy’s gains can be increased with a transplant. It
has been defined that an increase of 6 donors p.m.p. in a country like Germany will lead to 29
Qualy’s gains of patients with end-stage renal disease (calculation was made over a 20 years
period).29
Recently several studies have shown that investing in organ procurement is clear a good
health investment. Even considering the lack of data to complete the analysis, it is highly
likely that obtaining additional donors will be cost effective even at a much higher average
cost per donor
2) Productivity: The most important benefit for the grafted patients is measured in terms of
survival and improvement of perceived quality of life, and consequently integration to the
working and family life and productivity.
A raw estimation of the potential increase in donation rates in Europe could be done using
different scenarios (achieving at least the European average donation rate in those MS that
have lower rates, achieving the highest donation rate in Europe (Spain) in all MS and
achieving the theoretical highest rate in all MS (40 ppm)) In all these scenarios the potential
increase of organ donors is considerable (the figure below shows number of donors).
29 Leo Roels, Bernard Cohen, Caroline Gachet and Blanca Miranda. Joining Efforts in Tackling the Organ
Shortage: The Donor Action Experience. Clinical Transplants 2002;Chap. 8:111-120
Deutscher Bundestag – 16. Wahlperiode – 71 – Drucksache 16/7192
0
5000
10000
15000
20000
25000
Current
donation rate
EU donation
rate
Spanish
donation rate
Potential
donation rate
The population in need of an organ transplant is on average a young population; with many
productive years ahead,as the following table indicates:30
Liver Heart Kidney Lung
Average age at the
time of the transplant
50.5 49.4 50.7 46.2
Average age in the
Waiting list
50.7 48.9 50.5 47.6
Quality analysis and cost / benefit studies programmed for large samples and in different
countries will definitely establish the need of a minimal invest in the organ donor promotion
activities.
The next table shows the survival at 1, 3, 5 and 10 years posttransplant.31
Graft and patient survival at 1 year; 3 years, 5 years and 10 years post transplant
Kidney
Graft 88.4 78.5 63.3 36.4
Patient 94 88.4 79.9 59.4
Heart
Graft 84.4 77.5 68.1 46.4
Patient 85.1 78.6 69.8 50
30 Data provided by the ONT (Spanish National Transplant Organisation)
31 OPTN/STR Data
Drucksache 16/7192 – 72 – Deutscher Bundestag – 16. Wahlperiode
Liver
Graft 80.2 71.4 63.5 45.1
Patient 86.4 79.5 72.4 59.4
The Survival of patients without a transplant is clearly a worst scenario. For liver patients, we
can rely heavily on analyses presented in the Institute of Medicine’s (IOM’s) 1999 study. It
found that Status 1 patients on the waiting list are expected to survive only about one week
without a transplant. For Status 2B patients, about 25% of those not transplanted would die
within 12 months of listing; for Status 3 patients, about 10%.It could be assumed that all
Status 1 patients and the great majority of Status 2A patients die within one month.
For heart transplant patients, we lack a data source like the IOM study and turn to the UNOS
waiting list data. UNOS data for 2001 showed that those who were neither transplanted nor
removed from the waiting list for reasons other than death had a survival rate of 46% at 6
months, 32% at 12 months, and 20% at 18 months.
Similar conclusions could be drawn for the quality of live with or without a transplant.32
3) Upgrading of organisational structures: This proposal will have an impact on the activities
carried out within the Organ transplantation process. The establishments directly concerned
by the provision of this proposal vary from hospitals or health centres where procurement is
carried out, to third parties which can be responsible for some step of the process. The need of
standards of quality and safety could increase the cost of the process. On the other hand they
may help to reduce costs associated with adverse events and effects related to transplantation
and facilitate the exchange of organs across the borders. There are not many cost benefit
analysis of the introduction of quality and safety standards, and a detailed impact assessment
should be done if the adoption of a Directive on quality and safety is decided.
The latest analysis has been undertaken by Health Canada on the introduction of the new CSA
standards for blood, cells, tissues and organs. The conclusion of this analysis indicates the
strength of the case in favour of adopting the regulation clear rest on the discounted benefits
from extending lives. The analysis of avoided costs indicated that hospitals may not recover
their incurred costs in implementing the new standards. Benefits are concentrated in the
provision of better services to patients and mainly conferred on those patients through
extension of their lives and the quality of their lives. In conclusion for every standard,
estimated benefits over the next 20 years exceed costs by significant amounts. In particular
the benefits associated with implementing the standards on quality and safety in Canada for
perfusable organs for transplantation over the next 20 years discounted at 5 % per year were
estimated to be between $759.3 million and $1.4 billion; costs to organ donation organisations
and organ transplant programs to meet these standards were estimated at $202.8 million.
Obviously these calculations can not be directly transposed to the EU situation.
6.3. Assessing the impact on health and social welfare
1) Increasing organ availability will have an impact on the increase of organ transplant and
thus increase healthy life years. As mentioned in this document Organ transplantation is now
32 Mendeloff J; Ko K Roberts MS, et al. Procuring organ donors as a health investment: how much should
be willing to spend? Transplantation 2004; 78:1704.
Deutscher Bundestag – 16. Wahlperiode – 73 – Drucksache 16/7192
the most cost-effective treatment for end-stage renal failure, and for end-stage failure of
organs such liver, lung and heart, it is the only available treatment. Both quality/safety and
availability will have an impact on the improvement of quality of life and reduced suffering
for many patients and their families
Mean expected half-life for a deceased kidney grafted in the USA has increased by 75% from
1988 to 1996, rising from 7.9 to 13.8 years. When adjusted to exclude dead patients with
functioning graft, these data are 11 and 19.5 years respectively 33
Ten years survival rate for liver transplantation was 31% before 1988 and it has been
improved to nearly 60% in most European countries34. According to the Registry of
International Society for Heart and Lung Transplantation and the UNOS Registry, lung
survival has increased from 70.9% to 76% between 1990 and 199735.
Investment in organ procurement has proved to have a net social benefit. Other alternatives
such the use of living donation or the use of expanded donor has to evaluated. It is obvious
that there is a need to increase the number of available organs but not at any price. Safety and
quality levels need to be established at the same time.
2) The use of organs in therapy poses a risk of communicable diseases being transmitted to
the recipient. Because organs cannot be subjected to sterilization steps, the risk of infectious
disease transmission remains and thorough donor screening and testing is especially
important.
Basic quality and safety requirements will have an impact on risk reduction and consequently
in reduction of comortality and comorbidity.
To minimise the risks to the recipient, it is essential to screen donors and establish the
presence or absence of disease transmission risk in their organs. Pre-transplant evaluation of
potential donors is an essential part of solid organ transplantation. The goals are to identify
conditions which disqualify donors; to identify and active infection pre-transplant and to
define the level of risk in order to determine strategies for preventing post-transplant effects.
In the other side a very stringent set of binding safety and quality criteria could have as a
consequence a reduction in the actual number of donors. The fundamental premise is that
organs from donors with positive viral serology or history of malignancy are underutilised
because their organs might transmit disease. It is important a clear understanding of the
disease transmission risk inherent in each case. Although a definition of risk based upon the
profile is critical to rational decision-making, each decision also depends upon recipient
characteristics.
3).The new Member States face greater health problems than the rest of the Union but have
less economic means to address them. Their health systems are therefore under particular
pressure, in particular when it comes to the process from organ donation to transplantation,
which is such a complex process that it could be especially difficult to address. This leads to
33 Hariraran S. Johnson CP., Bresnatian BA., Taranto SE., McIntosh MJ., Stabilein D. Improved graft
survival after transplantation in the USA. 1988-1996. N.Eng.J.Med. 2000; 342:605-612.
34 European Liver Transplant Registry Report. www.eltr.org., Spanish Liver Transplant Registry
Report.www.msc.es/ont. Updated Sept. 2003.
35 UNOS Registry Data. www.unos.org. Updated daily
Drucksache 16/7192 – 74 – Deutscher Bundestag – 16. Wahlperiode
enormous differences within Member States in terms of accessibility to transplants and the
length of waiting lists. Collaboration at EU level can bring particular benefits to those systems
and favour the accessibility to these therapies to an important number of European citizens.
6.4. Environmental impact
There is no significant impact on environment.
7. COMPARING THE OPTIONS
7.1. Summary of contributions of the open consultation
General comments
A vast majority of respondents welcomed the Commission’s consultation paper, the
opportunity to submit contributions, and explicitly supported the outlined objectives. The
support for an EU action in this field was strongly emphasised. Broadly speaking, most of the
contributors agreed with the key principles and concepts underlying the Commission’s
consultation document.
There is a general consensus on the importance of ensuring the quality and safety of organs
for transplantation at EU level. Given the current situation of organ shortage, diverse opinion
came out during the consultation on how should be the best approach to this objective. A
major number of responses opted for option 3 (incorporating a Directive on organ quality and
safety); however an important number of responses considered option 2 (guidelines through a
strength cooperation method) as the preferable one.
0
5
10
15
20
25
30
Option 1 Option 2 Option 2-3 Option 3 No option
given
Others considered Option 2 as a “phasing in period”; and in the light of the work done
through the coordination method, the introduction of additional legislative instruments could
be considered. This option has been named as option 2-3 and also incorporate the responses in
favour of option 2 plus an initiative on organ trafficking but not a quality and safety Directive.
Many responses did not refer to particular options but gave interesting suggestions on
different types of activities that could be undertaken at community level.
Among the different categories of stake holders professionals, patients and donor associations
were majority supported to the third option.
Patients/donor assoc.
Deutscher Bundestag – 16. Wahlperiode – 75 – Drucksache 16/7192
Option 1
No option given
Option 3
Option 2-3
Option 2
0
1
2
3
4
5
6
7
8
Professionals/Scientific ass
No option given Option 3
Option 2-3
Option 2
Option 1
0
2
4
6
8
10
12
Should be pointed out that many of the stakeholders categorised into the
professional/scientific association have provides a good number of comments on possible
initiatives but without pointed out any specific option.
Organ Exchange Organisations (OEOs), National Agencies or public authorities are more
comfortable with the second option, although the support for the third option is also
considerable.
No option given
Option 3
Option 2-3
Option 2
Option 1
0
2
4
6
8
10
12
There is however a general agreement that the content of a hypothetic future directive should
be limited to establish a basic quality and safety framework for Europe and at the same time
should respect the clinical decision. Binding requirements should not represent any barrier for
organ donation, including the use under specific circumstances of the so call “expanded
donors”. A comprehensive assessment of the impact should be presented with the proposal.
Drucksache 16/7192 – 76 – Deutscher Bundestag – 16. Wahlperiode
There is a common agreement that Organ shortage is the main problem in the field. There is
also a majority of responses recognising the European added value of a Community action in
this field, only four among all the responses were against this general feeling.
Developing national or regional systems to an optimum level of performance is a prerequisite
for wider European cooperation. These systems need an appropriate legal framework, a good
technical approach and organizational support. Sharing best practices and expertise, getting
the best of the best models are some of the suggestion received.
For most of the participants a centralised European donor pool is not considered an option.
However contributors pointed out the added value on many European actions through an
active cooperation between Member States or existing OEOs, some of the actions mentioned
were the coordination of training of professionals, performing of a benchmark between
Member States to identify areas of improvement and determining priorities, coordination of
programmes oriented to facilitate the identification of organs for urgent patients and highly
sensitised patients, mainly in those small EU countries with limited size of their national
donor pools. Other actions identified were the development of consensus guidelines and
professional standards to ensure good medical practices or the evaluation of post transplant
results “organovigilance” including adverse event to lead to a safer and more effective use of
organ donors.
Promotion of the donation is also one of the most shared suggestions received during the
consultation. Awareness-raising activities have been suggested, it has also mentioned the need
to give to these activities a society oriented approach. The involvement of all stakeholders in
the process (regulators, health care professionals, patients and donors associations, media,
opinion and religious leaders, educational professionals, judges, etc…) has been pointed as a
key factor for success.
Many contributors pointed out that the use of living donors should be promoted
Accessibility of transplants have been recognised as a problem not only between Member
states but also within the member states, partially as a consequence of the ever shrinking
donor rate, but also has been pointed out that there are huge differences in access that cannot
merely be explained by differences in organs donor rates.
It has also pointed out that the accessibility to transplantation as a complex issue, like other
healthcare access issues and that it cannot be separated from it general healthcare
environment. Coordination between Member states will certainly be a factor to improve the
situation but will not be the only one. Access to transplant requires for example financial and
human resources on the long run.
Some contributions underlined the phenomenon of transplant tourism (potential recipients
from one country trying to get a transplant in another country with higher donation rates than
in their own country). An issue has been identified as not been addressed in the consultation
document, the growing number of non-EU citizens waitlisted for organ transplantation,
namely in regions of the European borders. This increases the current shortage of organs and
at the same time faces the EU with ethical dilemmas.
There is a general support of exploring initiatives to combat organ trafficking
Deutscher Bundestag – 16. Wahlperiode – 77 – Drucksache 16/7192
7.2. Comparison of the options
a) First level: Use of existing programmes only
AAADDDVVVAAANNNTTTAAAGGGEEESSS DDDIIISSSAAADDDVVVAAANNNTTTAAAGGGEEESSS
Projects funded by the Commission and
carried out by selected consortium have
been proved as a valuable tool to progress
forward a better understanding of the
problems and finding possible solution.
These programs have involved the professionals
on the field and offer enough flexibility for
Member States to tailor the results of the
initiatives to their own national situations.
However it is also recognised that the
coordination of these projects under
different Community programmes is quite
difficult and that a coordinate action taken
into account the results of all the initiatives
and avoiding overlapping is the most
efficient choice.
The participants in these projects do not
always represent all Member States, in the
contrary many times the best establish
systems are leading the projects and the
results will not probably benefit to the
whole Community.
The projects have a limited time frame and
limited resources with the risk that once
the project is finished the continuity of the
results is not ensured. In addition the
projects not always have the capacity to
transform the results of their investigation
to the political level in order to make them
operative.
Finally the projects will be seen as one of
the tools possible to ensure a high quality
of organs but they do certainly not qualify
as harmonising measures under Art. 152.4
which expressly confers powers to the
legislator to adopt harmonised measures in
this specific field.
b) Second level: Active coordination between Member States on organ quality, safety and
availability.
AAADDDVVVAAANNNTTTAAAGGGEEESSS DDDIIISSSAAADDDVVVAAANNNTTTAAAGGGEEESSS
It is very important that further work under
the exiting programmes is continued and
extended involving Member States and
relevant stakeholders. However the
outcome of these projects will only be
This option will address the real main
problem identified by the experts: the
organ shortage. However national
legislations differ between Member States
A national approach would not solve
useful if health authorities will abide by completely the quality and safety
Drucksache 16/7192 – 78 – Deutscher Bundestag – 16. Wahlperiode
their conclusions.
The development of pan European
cooperation, sharing best practices,
common safety and quality standards, and
the promotion and maximisation of organ
donation would all be beneficial in
developing agreed quantitative and
qualitative indicators and benchmarks and
aid future development of EU policy in the
light of further information and
experience. The Community should get
the best of the best models and support its
application in the entire EU. It is clear that
what Europe needs is not so many short-
lived programs that are hard to translate
into real practice, but rather a full flagged
agenda of priorities.
The Strength cooperation will not only
help to develop the national transplant
systems – a prerequisite for cooperation in
this field- but also will identify and foster
a number of activities that only can be
carried out –or at least with better result s-
at European level.
Promoting the coordination between MS
should be the main objective; these actions
must work with a minimum of red tape,
work load and cost. Emphasis should be
on collaboration and sharing best
practices, taking into account the differing
circumstances of each member state and
not setting uniform targets across member
States.
objective, in addition there are still a
number of European factors that have to
be taken into account, i.e. organ
interchanges within the community.
Coordination between MS has often
proved not to be such an effective tool
without any legal instrument supporting
the actions. Thus, this would most likely
lead to not fully meet the objectives under
Article 152. Basic common binding
principles should be in place to allow a
smooth cooperation.
c) Third level. Second level + Minimum harmonisation on quality and safety + initiative on
Organ trafficking
AAADDDVVVAAANNNTTTAAAGGGEEESSS DDDIIISSSAAADDDVVVAAANNNTTTAAAGGGEEESSS
Deutscher Bundestag – 16. Wahlperiode – 79 – Drucksache 16/7192
An appropriate and flexible European
legal framework is a better response to the
requirements under Article 152 of the
Treaty on quality and safety.
Finding the appropriate risk-benefit
balance for the patient is a key aspect.
While respecting the clinical role of the
doctor in the decision on the acceptance of
organs for transplantation, community
binding legislation would have an added
value in terms of ensuring the basic quality
and safety requirements across the
Community.
Every year, a number of organs are
exchanged between EU Member States.
Cross border exchanges imply that the
transplantation process is carried out by
hospitals or professionals falling under
different jurisdictions.
The increasing phenomenon of transplant
tourism (potential recipients from one
country trying to get a transplant in
another country with higher donation rates
than in their own country) is a reality.
Having common binding standards of
quality and safety will be the only
mechanism to ensure the same health
protection all along the EU.
Establishing a regulatory Committee under
a Community Directive will facilitate the
coordination activities within Member
States. In addition would show leadership
on pan European level and encourage
those non EU European Countries
currently without any form of transplant
legislation to give serious and formal
consideration to all areas of the
transplantation process
It should be explored how the initiatives
under Article 152 could address the issue
of organ trafficking and/or if they have to
be complemented with initiatives under
Articles 29, 31(e), and 34(2)(b) of the EU
Treaty (JLS), oriented to combat Organ
The legislative proposal may have difficult
practical consequences for MS which in
turn may lead to an actual decrease in
number of donors. It could be seen as a
burden for the organisation of transplants
and patient accessibility. This area relates
closely to “medical treatment” where the
role of the medical doctor is a key factor
and thus should be left to MS, where it
could be addressed in a more efficient
way.
Some MS are had reservation in the past in
relation with Organ trafficking. The
problem of Organ trafficking seems to
occur outside of the EU. It seems that
patients from EU MS, who are waiting for
transplants, travel to third countries in
order to receive donation which has been
taken forcibly or by a payment (usually
low).
trafficking in order that the EU could be
Drucksache 16/7192 – 80 – Deutscher Bundestag – 16. Wahlperiode
seen to be acting proactively rather than
reactively.
7.3. Conclusions
Undoubtedly an EU initiative on organ donation and transplantation has an added value.
The use of an open method of coordination, specifically adapted to this concrete field, and as
a complement to the legislative framework, will provide the necessary policy mix to achieve a
gradual approach to the development of an EU policy. This approach will be based, in the first
stage at least, on the identification and development of common objectives for which it is
agreed that a Community response is necessary, on agreed quantitative and qualitative
indicators and benchmarks, regular reporting and identification of best practices.
Deutscher Bundestag – 16. Wahlperiode – 81 – Drucksache 16/7192
The preferred option
The Commission propose a combined set of actions to respond to the proposed objectives, this
option could be represented as follows:
As first level of intervention the work under the deferent Community programmes should
continue during the coming years. It is important that the results of these projects, such
European registers on activities in this field with agreed methodology, coordination between
research programmes or development of methodologies to increase organ donation, have
continuity and are adopted at political level, these initiatives should also be made accessible to
all the Community.
Strengthen the cooperation between Member states, specifically adapted to this concrete field,
will provide the necessary policy mix to achieve a gradual approach to the development of an
EU policy. This approach will be based, in the first stage at least, on the identification and
development of common objectives for which it is agreed that a Community response is
necessary, on agreed quantitative and qualitative indicators and benchmarks, regular reporting
and identification of best practices.
The Commission in collaboration with Member States should determine common EU
guidelines for national polices, formulate the objectives for the short, medium and long term
and describe the instruments and methods needed.
Main objective: High level of human health protection (Article 152 of the Treaty)
Ensuring quality and
safety
Increase organ
availability
Avoid Organ
trafficking
Directive on quality
and safety + IA
Strengthened coordination between
Members States on organ donation and
transplantation
Initiatives against
organ trafficking
Guidelines
and
professional
standards to
ensure good
medical
practices and
the evaluation
of post-
transplant
results
Share
experience
and best
practices to
establish
efficient
systems for
organ donor
detection and
procurement
Promotion of
training of
professionals
based on best
experience
Promotion
of
donations
from living
donors and
the use of
expanded
donors
Increase
public
awareness:
European
donor card
Guidelines for
systems for
offering surplus
organs to other
countries, with
special reference
to the exchange of
organs for urgent
patients and
difficult recipients
The Commission in collaboration with Member States should define the exact and balanced
scope of the EU legal framework on quality and safety for human organs and present a
Drucksache 16/7192 – 82 – Deutscher Bundestag – 16. Wahlperiode
proposal to Parliament and Council, a comprehensive assessment of the impact should be
attached to the proposal. The future proposal should establish a basic quality and safety
framework for Europe. Binding requirements should not represent any barrier for organ
donation, including the use under specific circumstances of the so call “expanded donors”. A
comprehensive assessment of the impact should be presented with the proposal.
This legal framework should be complemented with the cooperation between Member States
leading to the compilation of sufficient information that will assist in determining the
acceptable levels of risk in the use of expanded donors and the promotion of consensus
guidelines and professional standards to ensure good medical practices and the evaluation of
post transplant results: “organovigilance”
The Commission should promote cooperation between Member States on sharing experiences
and best practices oriented to establish efficient systems for organ donor detection and
procurement. The objective should be to get the best of the best models while respecting the
cultural and organisational diversity.
Other areas where active cooperation is important to increase organ availability are the
promotion of training of professionals based in the best experiences; to explore the promotion
of donations from living donors, to evaluate the procurement of organs from non-heart-
beating donors; and the use of “expanded donor” taking into account the quality and safety
aspects mentioned in the previous section.
It will be also important to join efforts and expertise in order to increase public awareness. In
this context the creation of a European organ donor card or its incorporation on the existing
health card should be considered.
Healthcare access issues cannot be separated from it general healthcare environment and has
to be seen in relation with other initiatives at community level in this area.
It should be focus in identifying the most efficient systems, sharing experience and promoting
best practices in accordance with local characteristics. Those Member States whose transplant
systems are not yet sufficiently developed could be supported and guided in their efforts to
improve patient care
Other actions should be oriented to identify the needs at EU level for the interchange of
organs. Guidelines for systems for offering excess organs to other countries could be
evaluated and in particular exchange of organs for urgent patients and difficult recipients (e.g.
children, highly sensitive patients).
The increasing mobility of people within the EU makes necessary to identify the main
problems on patient mobility. It will be also important a EU-wide agreement on all issues
concerning transplant medicine for extra-Community patients ("non-residents").
Finally it will be needed to explore how the initiatives under Article 152 could address the
issue of organ trafficking and/or if they have to be complemented with initiatives under
Articles 29, 31(e), and 34(2)(b) of the EU treaty (third pillar)
An assessment of the specific measures once decided should be done and presented with the
proposals, for each particular initiative the benefits should be quantified and contrasted with
the degree of intervention in so far as this is possible.
Deutscher Bundestag – 16. Wahlperiode – 83 – Drucksache 16/7192
8. MONITORING AND EVALUATION
As stated in the EC Impact Assessment Guidelines (SEC (2005) 8 June 2005) the road map
for monitoring progress should “set measurable indicators to cover both the quality of
outcomes and the implementation process, and define plans for evaluation.”
The structure of the Communication and the annexed Action Plan provides that for each aim
there are actions. Indicators, timeframe and responsible parties will be identified and
developed in cooperation with relevant partners/stakeholders.
Drucksache 16/7192 – 84 – Deutscher Bundestag – 16. Wahlperiode
Annex I Medical Background Information
TRANSMISSION OF COMMUNICABLE DISEASES.
Human immunodeficiency virus (HIV). The majority of the cases of HIV-1 transmission
through organ transplantation were described before the existence of the serological tests.
However there are also cases of HIV-1 transmission described after the introduction of the
tests, they were false negatives during the “window” period –the time delay between viral
exposure and detectible antiviral antibodies36. There are not cases described of HIV-2
transmission.
The effectiveness of the transmission is difficult to know, but it is assumed that is nearly
100% through solid organ transplantation from a donor HIV positive37. HIVAc (+ ) donors
carry a high risk of viral transmission, the infectivity of a small inoculum has been
demonstrated by blood transfusion studies4.
All potential organ donors have been screened for HIV since 1985. The rare instances of HIV
transmission despite negative HIVAc test results illustrate some limitations of serologic
testing. In one instance, massive transfusion of blood and blood components decreased the
antibody titer below the sensitivity limits of EIA. In a second case, transmission occurred
from a donor during the “window period”.
The transmission through these false negatives should be prevented through a good clinical
and behavioural history of the donor. See point 3 and 4 below.
Hepatitis B virus (HBV). The cases of HVB transmission have decreased due to the
serological screening, which normally includes Ag HBs test.
Kidney was the first graft involved in a case of HBV transmission.
There are studies that indicate that more than 1% of potential donors have an active HBV
infection and over 12% in hyper endemic areas. 3-4% donors have a past history of HBV
infection in countries with low prevalence like USA and over 10% in some European
countries.
The risk of transmission from donors with test against Antigen Hepatitis B (Ag HBV) positive
is nearly 100%. However the transmission of HBV to the recipients is also possible from
donors Ag HBV negative that have other serological markers positives38.
The risk of transmission by liver transplantation from a donor with a serological antibody
(HBVAb ) test positive against hepatitis B is higher because HBV resides principally within
36 Screening of donor and recipient prior to solid organ transplantation. American Journal of
Transplantation 2004 (Suppl. 10): 10-20
37 Criterios de selección del donante de órganos respecto a la transmisión de infecciones. 2ª edición. 2004.
Organizacion Nacional de Transplantes.
http://www.ont.es/Consenso?id_nodo=263&&accion=0&keyword=&auditoria=F
38 Feng S.; Buell J.F. Cherikh W.S., et al. Organ donors with positive viral serology or malignancy: risk of
transmission by transplantation. Transplantation 2002; 74 (12): 1657-1663
Deutscher Bundestag – 16. Wahlperiode – 85 – Drucksache 16/7192
the hepatocytes 4,39,40. The donor´s Hepatitis B Antigen status do not mitigate transmission
risks41. This type of donors represent in some countries between the 5-15% of all donors42.
In contrast with liver transplantation, transplantation of kidneys from HBcore antibody
positive donors seems to carry a minimal risk of clinical transmission. A meta-analysis of the
literature shows that only 1 of 133 recipients converted to HBs Antigen positive after
transplantation of a kidney from an HBc antibody positive donor43 44.14. It should be noted,
however, that the actual rate of viral exposure as measured by development of anti-HBV
antibodies (either HBsAb or HBcAb) is considerably higher. 27 % of kidney recipients from
HBcAb + donors demonstrated seroconversion compared with 4% of kidney recipients from
HBcAb - donors, for an odds ratio of 4.94 4.
Some studies indicate that the risk of transmission is 15-78% for liver transplantation, 2% in
kidney and 0% in heart transplantation.
An additional problem that could be found in donors Ag HBs positive is the co-infection with
the virus of hepatitis delta (VHD). It has been described the transmission of this virus trough
kidney transplantation resulting on severe acute hepatitis.
Hepatitis C virus (HCV) Transplantation of an organ from an HCV+ donor is known to be an
efficient mode of viral transmission 4,45,46,47,, . Approximately 5% of all potential donors in
USA and Europe are positive for Antibody HCV48.
A positive HCV-RNA, indicative of viral replication, has been associated with a higher risk of
transmission.49. The transmission from donors with RNA positive is estimated to be nearly
100%. The risk of transmission from a non RNA positive donor is not known.
The consequences for the recipient of an organ from a HVC positive donor are the
seroconversion in 50-67% of the cases and the percentage of development of hepatic disease
is around 35%.
39 Dodson SF, Issa S, Araya V, et al. Infectivity of hepatic allografts with antibodies to hepatitis B virus.
Transplantation 1997; 64 (11): 1582
40 Uemoto S, Sugiyama K, Marusawa H, et al. Transmission of hepatitis B virus from hepatitis B core
antibody- positive donors in living related
41 Dickson RC, Everhart JE, Lake JR, et al. Transmission of hepatitis B by transplantation of livers from
donors positive for antibody to hepatitis B core antigen. The National Institute of Diabetes and
Digestive and Kidney Diseases Liver Transplantation Database. Gastroenterology 1997; 113 (5): 1668.
42 Data from ONT, Spain
43 Madayag RM, Johnson LB, Bartlett ST, et al. Use of renal allografts from donors positive for hepatitis
B core antibody confers minimal risk for subsequent development of clinical hepatitis B virus disease.
Transplantation 1997; 64 (12): 1781.
44 Satterthwaite R, Ozgu I, Shidban H, et al. Risks of transplanting kidneys from hepatitis B surface
antigen- negative, hepatitis B core antibodypositive donors. Transplantation 1997; 64 (3): 432.
45 Wreghitt TG, Gray JJ, Allain JP, et al. Transmission of hepatitis C virus by organ transplantation in the
United Kingdom. J Hepatol 1994; 20 (6): 768
46 Tesi RJ, Waller K, Morgan CJ, et al. Transmission of hepatitis C by kidney transplantation–the risks.
Transplantation 1994; 57 (6): 826.
47 Pereira BJ, Wright TL, Schmid CH, Levey AS. A controlled study of hepatitis C transmission by organ
transplantation. The New England Organ Bank Hepatitis C Study Group. Lancet 1995; 345 (8948): 484.
48
Candinas D, Joller-Jemelka HI, Schlumpf R, et al. Hepatitis C RNA prevalence in a Western European
organ donor pool and virus transmission by organ transplantation. J Med Microbiol 1994; 41 (4): 220.
49 Fishmen JA, Rubin RH, Koziel MJ, Pereira BJ. Hepatitis C virus and organ transplantation.
Transplantation 1996; 62:147-154.
Drucksache 16/7192 – 86 – Deutscher Bundestag – 16. Wahlperiode
Overall, limited available data validate the assumption that heart or lung transplantation
presents a similar risk of HBV or HCV transmission as kidney transplantation. Finally with
regard to outcome, no conclusions can be drawn because the specific impact of the donor’s
positive serology cannot be discerned from the available data.
Other Viruses Human T- Linphotrofic virus (HTLV-I and II) is endemic in certain areas; out
of these areas the prevalence of this infection is low (lower that 1 % or even 0.1%). Infection
with HTLV progress after years or decades to associated myelopathy spastic paraparesis or to
adult cell leukaemia/lymphoma (ALT); progression occurs in less that 1% and 2-‘%
respectively. Cases of ALT after transplantation have been reported.
West Nile virus (WNV) is a flavivirus which can cause meningoencephalitis. In the fall of
2002, transmission of WNV from a single donor to four organ donors has been reported. An
additional case through liver transplantation has appeared. In August 2002, fever and mental-
status changes developed in recipients of organs from a common donor; transmission of WNV
through solid organ transplantation was suspected. Transplant recipients can acquire WNV in
1 of 3 ways: (1) transfusion transmission, (2) organ donor transmission, and (3) transmission
in the community. Posttransplant immunosuppression increases the risk of developing severe
disease after WNV infection. In the general population, WNV causes severe neurologic
disease in < 1% of infected patients. However, data from a seroprevalence study suggest that
the incidence is as high as 40% in organ transplant recipients.
Although prevention strategies are critical, there is disagreement within the transplant
community about the use of nucleic acid testing for screening of organ donors for WNV
because screening results can be affected by a number of factors, including local WNV
activity, test availability, and test characteristics.
Bacterial and fungal infections. A bacterial or micotic infection or colonisation can be present
in 60 % of deceased organ donors and mainly affect the respiratory and urinary tract.
Bacterial and fungal donor to host transmission with the allograft with result of loss of the
infected graft or death of the recipient has been widely documented. Nevertheless an adequate
antibiotic treatment of donor and/or recipient should prevent infection in the latter.
Micobacterium tuberculosis has been transmitted by transplantation, donor transmission
accounted for approximately 4% of reported post-transplant TB cases in a large review of 511
patients50.
Transmission of histoplasmosis by transplantation has been described, but most cases appear
to be the result of reactivation of past infection in the recipient. Transmission of
Coccidiodomycosis by lung transplantation has also been reported.
Parasitic infections
There are 342 parasitic species that are known to infect humans, mostly affecting those in
tropical and subtropical regions51. Recently however there are been a considerable spread of
50 Singh N; Paterson DL; Mycobacterium tuberculosis infection in solid organ transplantation recipients:
impact and implications for management. Clin infect Dis 1998; 27 1266-77
51 RS Barsoum Parasitic Infections in Organs transplantation. Experimental and clinical Transplantation
Vol 2. 2. December 2004
Deutscher Bundestag – 16. Wahlperiode – 87 – Drucksache 16/7192
these infections to the rest of the world as result mainly of travel and migration. Only 5% of
the known human pathogenic parasitic infections have been reported in transplant recipients.
Malaria transmission has been reported with kidney, bone marrow and multi-organ
transplantation. Toxoplasmosis is a major concern particularly on heart transplantation.
Toxoplasma has rarely been transmitted to liver and kidney recipients.
Transmission of Chagas diseases is a significant problem in endemic areas, and recently has
been reported in the US.
Prion infections
Creutfeld Jacob disease has been transmitted with treatment with growth factors and with
transplantation of cornea and duramater grafts. In July 2004, the United Kingdom announced
that a second instance of probable vCJD (new variant) transmission via blood transfusion had
been identified. The patient received the blood donated by an individual who was confirmed
in 2001 as a definitive vCJD case.
TRANSMISSION OF MALIGNANT DISEASES
First report of the UNOS (1994-96) showed a frequency of donors
with malignant cancer history of 1.7% and a rate of transmission
of cancer from donor to recipient of 4.3%.
United Network for
Organ Sharing
(UNOS) transplant
tumour register52
A more recent report from this registry (1994-2000 period)
showed 14 donors with tumour from a total of 35.503 donors (4
per 10.000) and tumour transmission to 15 recipients of 109.749
transplants (1.3 per 100.000). The tumors transmitted were the
following: 4 melanomas, 1 neuroendocrine tumor, 1
adenocarcinoma, 1 cancer of the pancreas, 1 nondifferentiated
squamous carcinoma, 2 lung cancers, 1 small cell carcinoma, 1
oncocytoma, 1 papillary tumor, 1 breast cancer, 1 prostate cancer)
Organización
Nacional de
Transplantes (ONT)
register
The frequency of donors with no detected tumour was 6.1 per
1000 donors during the last 15 years. Five of these donors
transmitted the disease (2.9 per 10.000 donors). Ten recipients of
the 155 that received an organ from a donor with undetected
cancer developed a tumour (4.6%). The tumours transmitted were
1 sarcoma, 1 germ cells carcinoma, 1 undifferentiated
52 Kauffman HM, McBride MA, Delmonico FL. First report of the United Network for organ sharing
transplant tumor registry: donors with a history of cancer. Transplantation 2000; 70 (12): 1747-51
Drucksache 16/7192 – 88 – Deutscher Bundestag – 16. Wahlperiode
carcinomatosis and two kidney carcinomas.
Danish Register53 Bikerland studied a cohort of donors during 27 years funding 13
malign tumours within 626 donors (2% of the donors) From these
donor only one has transmitted the tumour (a melanoma) to the
recipient (2 per 1000 donors)
Centro Nazionale
per i Trapianti
(CNT) register
The CNT has put in place a new strategy for the evaluation of
donors since 2002. The analysis of the period 2001-2002 showed
2.9 % of donors with tumours.
The Israel Penn
International
Transplant Register.
(IPTTR)54
The I. Penn register shows higher frequencies of tumour
transmission that the ones above. During 1994-2001 it registered
68 recipients of organs coming from donors with renal carcinoma,
with a tumour transmission in 43 of them (43%). 30 recipients of
organs received from donors with melanoma, with tumour
transmission in 23 (77%); 14 recipients received from donors with
melanoma, 14 recipients with coriocarcinoma, with tumour
transmission in 13 (93%). Other tumours that have presented
transmission to recipients were lung (41%), colon (19%), prostate
(29%), Kaposi Sarcoma (67%).
53 Arvid Bikerland S, Storm H. Risk for tumor and other disease transmission by transplantation: a
population-based study of unrecognized malignancies and other diseases in organ donors.
Transplantation 2002; 74 (10): 1409-13
54 Feng S, Buell J, Cherikh WS, Deng MC, Hanto DW, Myron Kauffman H, Leichtman AB, Lorber MI,
Maters RG, Mcbride MA, Metzger RA, Nolte FS, O´Connor KJ, Roth D, Terrault NA, Henry M. Organ
donors with positive viral serology or malignancy: Risk of disease transmission by transplantation.
Transplantation 2002; 74 (12): 1657-1663