1. 1st Internatonal symposium, Istanbul 29-31 May 2014 1 Ethical and legal issues in Deceased organ donation – a birds eye view Michael Bos 1 st International symposium Istanbul, Turkey

2. 1st Internatonal symposium, Istanbul 29-31 May 2014 2 Actual situation in Turkey 2014: >50.000 patients in Turkey with kidney failure, and in need of transplant Expected to rise to 80.000 in 2016 Only 17% have been transplanted Main problem: lack of coordination between ICU medical staff and MOH organ donation organization Also, high rate of family refusal for deceased donation 2001: National transplantation Coordination system (MOH)

3. 1st Internatonal symposium, Istanbul 29-31 May 2014 3 European picture countryDeceased donors pmp Kidney TX deceased donors pmp All kidney tx pmp Spain35,146,854,5 Croatia34,850,552,5 France25,942,347,9 Norway23,443,659,8 Italy21,926,129,3 Germany12,822,231,5 Greece6,811,415,0 Turkey4,67,039,0

4. 1st Internatonal symposium, Istanbul 29-31 May 2014 4 Public appeal campaign Organ donation week 3.7% of population now registered as organ donor National databank is needed

5. 1st Internatonal symposium, Istanbul 29-31 May 2014 5 Legislation: opt-in system Turkish law 2238 (1979) and Addendum 2594 (1982) Very basic law: 4 chapters, 17 articles Buying and selling of organs is forbidden Live donation ≥18 yrs, mental capacity Death determined by 4 doctors, following medical state- of-the-art (brain death) Permission for donation and transplantation can be given by deceased person (verbally or written), or next-of-kin If next-of-kin do not exist, or cannot be found, donation and transplantation can take place without permission of next-of-kin in a patient whose life depends on it

6. 1st Internatonal symposium, Istanbul 29-31 May 2014 6 Alternative system: opt-out E.g. Belgium, France, Spain Organ donation is allowed in persons, who – during life – have not expressed and/or registered an objection (= first person consent) Permission from next-of-kin is not legally necessary (but they are usually consulted)

7. 1st Internatonal symposium, Istanbul 29-31 May 2014 7 Differences opt-in vs opt-out In most opt-in legislations, permission for organ donation can be given: 1) by the deceased person (in a registry, on a donor card) 2) if no decision by deceased person<, next of kin can decide In opt-out legislation, it is basically always the deceased persons whose decides (first person consent)

8. 1st Internatonal symposium, Istanbul 29-31 May 2014 8 Brain death issue 1968: Harvard criteria ‘A person is dead when his brain is dead’ (C. Pallis) uniqueBrain death is accepted as the unique definition of the death of a person Medical and philosophical concept

9. 1st Internatonal symposium, Istanbul 29-31 May 2014 9 Whole brain death vs brain stem death Most countries have accepted whole-brain death criterium: irreversible loss of all functions of the brain, incl. brain stem UK: follows brain-stem death criterium – death is when the essential function of the brain stem is irreversibly lost Most western countries have brain death protocol: standardized diagnostic and additional testing guidelines

10. 1st Internatonal symposium, Istanbul 29-31 May 2014 10 Situation in Turkey Total brain death declarations (2014): 5341 brain dead patients in Turkey, but only 345 actual donors (4.6 pmp) Only 20% of family with brain dead donor consent to donation 1800 patients waiting for organ die every year Most of the 5449 transplants are with live donor Reasons for low number: Low trust in brain death determination Religious (Islamic) objections against organ donation 1980: High Council for Religious Affairs in Turkey ruled that Islam allows organ donation and transplantation (as does Islamic code of medical Ethics, and most Islamic religious leaders) – Declaration no. 396

11. 1st Internatonal symposium, Istanbul 29-31 May 2014 11 Islamic criticism of brain death Some religious critics: Islam defines ‘death’ as the separation of the soul from the body; however this does not occur in brain death. Ismail Yakit (theologian): the definition of death cannot be based on the separation of body and soul, as there is no exact (scientific) definition and manifestation of the soul. Doctors should define and determine death (irreversible loss of function, no chance of recovery)

12. 1st Internatonal symposium, Istanbul 29-31 May 2014 12 Other reasons for resistance Deceased donation is seen as taking part in a sort of black market for organs (popular misconception) Donating an organ damages the physical integrity of the body (however donors get proper treatment to preserve this outward integrity)

13. 1st Internatonal symposium, Istanbul 29-31 May 2014 13 Issue of consent First person consent vs family consent What if deceased has consented, but family refuses? Who has last word in decision? What if family members disagree? Should it be decision of spouse or wider family?

14. 1st Internatonal symposium, Istanbul 29-31 May 2014 14 Family guidance during organ donation Many family refusals are caused by insufficient or conflicting information & guidance from staff (J. Rodrigue) Best approach is to have one experienced person (nurse, doctor) as liaison throughout the donation procedure (UK – Specialized Nurse for Organ Donation) Family must be assured that patient gets optimal care, also when donation is refused or not taking place

15. 1st Internatonal symposium, Istanbul 29-31 May 2014 15 End-of-life care and DCD Donation after Circulatory Death is another approach to deceased organ donation DCD does not take place in Turkey? (no data available in Global Observatory) DCD involves: a) withdrawing/withholding life support care (controlled DCD) b) stopping after unsuccessful resuscitation effort (uncontrolled DCD)

16. 1st Internatonal symposium, Istanbul 29-31 May 2014 16 DCD and best interests principle Decision to stop life support/treatment is taken because further treatment is ‘not in the patients best interest’ Decision to withdraw treatment is a medical decision made by physician/team, based on notion of ‘futile care’ Decision to withdraw treatment is not taken with an eye on organ donation

17. 1st Internatonal symposium, Istanbul 29-31 May 2014 17 Determination of death in DCD More problematic than in brain dead patient No standardized tests Essential issue is circulatory and respiratory arrest (following cardiac arrest) 5-minute time interval (no-touch time) is observed to ensure that circulatory arrest is permanent/irreversible (resulting in lack of circulation in the brain and irreversible damage)

18. 1st Internatonal symposium, Istanbul 29-31 May 2014 18 Donor management Treatment of a dying (DCD) or brain dead (DBD) donor, with aim to maintain physical function, optimize organ viability and chance of successful transplantation. If a patient has (himself or through family) consented to donation, donor management is in his best interest (even if it results in some harm/distress)

19. 1st Internatonal symposium, Istanbul 29-31 May 2014 19 Allocation of organs Aim to distribute organs from deceased donors according to objective, medically based allocation algorithm HLA-based, Meld-system, LAS-score etc. Ethical debate whether aim should be to: a) serve sickest/most urgent patient first b) avoid primarily death on waiting list c) get best transplant outcome (survival, QoL)

20. 1st Internatonal symposium, Istanbul 29-31 May 2014 20 Should there be priority groups? Pediatric patients (pediatric organs, small adults, young donors <35 yrs) Old-for-Old (>65 yrs donors to >65 yrs recipients) Highly immunized patients Acceptable mismatch patients Rare phenotypes

21. 1st Internatonal symposium, Istanbul 29-31 May 2014 21 What to do with discarded organs? Some organs are retrieved but not transplanted for quality reasons What should be done with these organs? Used for research and education Destruction Sent back to donor (for burial/cremation) Almost no legal regulations for this

22. 1st Internatonal symposium, Istanbul 29-31 May 2014 22 Finally… Thank you for your attention! Any questions?