CEOM BRUSSELS MEETING November 30, 2012 Ethical and Deontological Questions on Organ Donation and Transplantation [email protected] CHU Sart Tilman, University of Liege-Be President of the French Speaking Society of Transplantation Why should the Medical Council of Physicians be interested in Organ Donation and Transplantation? 1. Historical considerations and EU directives (2010/45-53/UE – 2012/25/UE) 2. Belgium amongst the world and EU 3. Belgian developments in Organ Donation and Transplantation and responses to EU directives (ACS) 4. Current problems with an EU perspective 1. Historical considerations and EU directives The CEOM objectives: - Promotion of quality in Medicine with respect to patients - Cooperation between organizations to elaborate: - Guidelines for quality - Commun ethical and deontological strategies (and rules) - Free circulation of health professionals, medical regulation, training and education - Patient information and free choice - … - Relationships with pharmaceutical industries and health authorities. 1. Historical considerations and EU directives The Belgian code of medical deontology: Art 5: taking care of all patients: no cultural, social, psychological…discrepancies. Art 6: help for urgent care. Art 27: free choice of physicians. But it could happen limitations for good quality care. Art 28: out of urgent care, a physician is allowed to stop… Art 29: need for informing patients. Art 30: minors – adults with no legal capacity. 31 1. Historical considerations and EU directives The Belgian code of medical deontology For Organ Donation and Transplantation: Art 53: application of current law on organ donation and transplantation (based on presumed consent): search for opposition. Art 98: when a patient is dead, all therapies must be stopped. Care could continue for organ donation according to patient wishes. Art 134: autopsy and legal aspects. The respect of the body. 1. Historical considerations and EU directives TTS, ESOT, SFT, BTS…actions: Amsterdam forum: living donor renal transplantation. Vancouver forum: living donor care (liver, pancreas, lung, bowel…). Declaration of Istanbul. WHO Resolutions: striving to achieve Self-Sufficiency WHA 44.25 May 1991 WHA 57.18 May 2004 WHA 63.22 January 2009 1. Historical considerations and EU directives Action Plan 2009/2015 EU directive 2010/45 and 2010/53 Quality – Security EU directive 2012/25 Tracability 2. Belgium amongst the world and EU Belgium = 10.4 x 106 inhabitants = 1 ET region + NL (1) + Lux (1) + G (7) + Au (1) + SL (1) + Cr (1) + …H (1) + Es (1) = 1 member state (27) 3. Belgian developments in organ donation and transplantation La Transplantation, Mythes, Légendes et Réalités Les Premières Transplantations chez l’animal La chirurgie vasculaire et l’Ecole Lyonnaise: Alexis Carrel et la « triangulation » (Nobel 1912) Les Premières Transplantations chez l’animal La chirurgie vasculaire et l’Ecole Lyonnaise: Mathieu Jaboulay et Alexis Carrel Sutures vasculaires La désinfection des plaies (1914): Carrel/Dakin L’échange d’une patte (1913) Le cœur-poumon artificiel avec Charles Lindberg Les premières greffes entre humains L’Ecole Russe: Voronoy (Kiev, Kherson 1933) Rec: femme 26 ans. Intoxication sublimé de mercure (O) Don: homme 60 ans. Trauma cranien (B) 5ml/h au J2 Décès de la patiente au J4 Pas de thrombose Les premières greffes entre humains L’Ecole Française: Serge Voronoff (Collège de France) 1928: Refus du Procureur de la République Rec: Jeune fille. Tbc rénale Don: Don de son corps à la science Criminel condamné à être décapité Greffes du testicule de singe à l’homme Les premières greffes entre humains L’Ecole Française (1951) Dubost et Œconomos; Servelle et Rougeulle Reins de guillotiné Küss, Teinturier et Milliez Rein de Matson Implantation: vaisseaux iliaques Les premières greffes entre humains L’Ecole Française (Noël 1952) Madame Renard et son fils Marius - Necker Les premières greffes entre humains L’Ecole Américaine Les jumeaux de Boston (Décembre 1954) Implantation selon la technique parisienne Les Premiers Succès de l’homogreffe Les jumeaux: 19 cas colligés en 1956 mais 30% de récidive de GNC Les antigènes de Transplantation: Jean Dausset en 1952 Immunodépression par irradiation suivie de greffe de moelle (Boston 1958) Faux jumeaux (Boston 1959) (Necker 1959) Transplantation hors gémellarité (Küss 1960) Irradiation – 6 Mercaptopurine Les Premiers Succès de l’homogreffe (1962) L’avènement de médicaments immunosuppresseurs en remplacement de l’irradiation totale: David Hume (Richmond): DCD; 21 ans de survie 6-Mercaptopurine (6-MP) Azathioprine Les Premiers Succès de l’homogreffe (1963) Le congrès de Washington: 244 homogreffes rénales (28 jumeaux vrais) Les premières greffes hépatiques et une série de 27 greffes rénales (25 succès) Perfusion initiale de macrodex froid (Roy Calne) Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD Professeur G.P.J. Alexandre Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD Alexandre : Dr. Gierts spoke about taking organs from a dying person. I would like to make it clear that, in my opinion, there has never been and there never will be any question of taking organs from a dying person who has “non reasonable chance of getting better or resuming consciousness”. The question is of taking organs from a dead person, and the point is that I do not accept the cessation of heart beats as the indication of death. We are as much concerned with the preservation of life in a dying person as with the preservation of life in a fœtus : but I think irreversible damage to the central nervous system is an indication of physiological death that permits us to take an organ from a body that is already a cadaver Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD Starzl : Dr. Giertz has drawn a distinction between the Stockholm case and the practice in Belgium which seems to me to be largely quantitative. I assume that when kidneys are removed from “living cadavers” in Louvain, only one organ is removed, so that the patient is not thereby killed. How long did your patients continue to be heart-lung preparations, Dr. Alexandre ? Were there any specific differences in the subsequent care of your cases and of the Stockholm patient ? The Swedish patient continued to be on the respirator after the kidney was removed. If, in your practice, the respirators is turned off immediately after the kidney is removed this could very easily explain the different survival times of less than one hour in Belgium, and 48 hours in Stockholm. Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD Alexandre : In our nine cases we switched off the respirator immediately after the kidneys were removed. The heart beats of all the patients ceased within two or three minutes. In my opinion it is irrelevant whether a heart-lung preparation goes on for two days or even for weeks : it is still a heart-lung preparation and for us it is still a dead person. Starzl : The notion of permitting removal of our organs while we still have a circulation is an important one. Personally I would agree to this for myself, but I could not permit this to be done to a member of my family. Progrès liés au prélèvement de greffons sur les morts 1964, octobre: mort cérébrale par hémorragie intracrânienne (Necker) 1965: hôpital Foch 1965: Uniform Act 1968, avril: circulaire Jeanneney 1968: Ad Hoc Committee Harvard School of Medecine Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD 1967 : First heart transplantation (Christiaan Barnard) 1968 : First heart transplantation in Fr. (Christian Cabrol) 1968 : First lung transplantation in Be.(Fritz Derom) 1969 : First liver transplantation in Be (P.J. Kestens) 1973 : First heart transplantation in Be (G. Primo) 1982 : First pancreas transplantation in Be (J.P. Squifflet) Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD June 1986 : Belgian law on Organ Donation and Transplantation Soft version of the presumed consent principle (opting out system ). The transplant surgeon cannot start any organ procurement : If the donor had expressed opposition at the National Registry. If opposition is communicated in any way to the surgeon. If a first degree relative expresses opposition. Death is not specified : brain death or cardiac death. Death must be reported by 3 physicians. Violent death must be reported to the Public Prosecutor. Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD June 1986 : Belgian law on Organ Donation and Transplantation 2007-2011 : Be, the leading country for MOD’s : 27.5 cadaver donors pmi 86.5 cadaver organ transplants pmi (43.0 kidneys; 22.7 livers; 8.7 lungs; 6.7 hearts; 5.3 pancreases and islets) Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be. First ever Heart Beating Donor MOD Age distribution Effective Donors 1990 – 2009 44% women / 56% men in 2009 Age distribution 59+ 40-59 20-39 <20 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 Average age 2009 effective donors: 48,35 yrs Youngest donor: 8 months Oldest donor: 86 years Landmarks in cadaver Organ Procurement in Belgium June 1963 : First cadaver kidney transplantation in Be.